clinical research associate education level

• Top Courses
• Online Degrees
• Find your New Career
• Join for Free

How to Become a Clinical Research Associate

A clinical research associate acts as a liaison between research sponsors and the clinics conducting research. Here’s how you can become one.

Every pill, vaccine, procedure, therapy, or medical device that might be prescribed or used on you to improve your physical or mental health undergoes clinical research trials. During these trials, a drug might get approved for the Food and Drug Administration (FDA) or a medical device approved for consumer or hospital use. 

Clinical research associates (CRA) play a critical role in the health care industry and improving public health . They act as liaisons between those who sponsor research and those who facilitate clinical research. Even prior to the COVID-19 pandemic, rising population density and international travel have increased the spread of new and existing diseases. Clinical research is necessary to gain evidence-based insights on how well a drug or vaccine does.

A career as a clinical research associate can be rewarding for individuals who are excited by the prospect of a dynamic role overseeing many different kinds of clinical trials. Here’s how to get started.

What is a clinical research associate?

Clinical research associates, also called “monitors,” are individuals who act as liaisons between the institutions that sponsor and fund the clinical research trials, and the clinics that conduct the research. They are in charge of making sure the clinical trials run smoothly, monitoring all the procedures, processes, and results, ensuring the researchers are following established guidelines and protocols every step of the way. 

A clinical research associate works on behalf of the sponsor (pharmaceutical company, university, or health organization) or for a contract research organization (CRO). The CRO typically funds the research. Clinical trials are the long, scientific process of ensuring that certain drugs, therapies, and devices are safe and effective for public consumption and use. CRAs guide the trials forward in accordance with regulations for ethics and safety.

Clinical research associates work on a team of research professionals. This is the hierarchy:

Contract research organization (CRO) or sponsor (university, pharmaceutical company)

Principal investigator (PI)

Clinical research associate (CRA)

Clinical research coordinator (CRC)

Clinical research associate job description

As a clinical research associate, these are the typical tasks and responsibilities:

Monitor the clinical research process, including managing supplies and coordination

Oversee data collection and documentation, and inputting data into systems databases

Outline the trial objectives and present the trial protocols to a committee

Coordinate with an ethics committee that protects trial subject confidentiality

Prepare post-trial reports and manage creating the publications

Field-based CRAs travel to different locations to deal with medical professionals in clinics or hospitals. Some CROs hire in-house CRAs to focus only on document review and management, making only occasional site visits.

Where you’ll work

Skills needed.

Clinical research associates need to have certain skills to get hired and be successful in their roles. Whether or not you currently possess these skills, it is possible to learn and acquire them through taking online courses or on the job. Some important skills you’ll need include: 

Administrative skills, including the ability to document important information accurately

IT and computer skills, such as databases and systems management

Written and oral communication skills

Keen attention to detail and organization

Ability to manage and coordinate with several stakeholders

Strong understanding of the clinical research trials and health care space, along with medical terminology

Clinical research associate salary and job outlook

The salary for a clinical research associate can vary depending on your organization and experience level. Clinical research associates can earn a median salary of $95,310 per year, according to the US Bureau of Labor Statistics [ 1 ]. On Glassdoor, the average annual base salary is $69,236 and a total salary of $108,425 [ 2 ].

Clinical research associate was ranked fourth on CNN Money’s Best Jobs in America in 2012, which listed the median pay as $90,800 with a top pay of $129,000 [ 3 ]. Overall, the salary for this role can be high.

How to become a clinical research associate.

A career as a CRA can be fulfilling because you are essentially a part-translator, part-project manager, and part administrator for trials that have the potential to save lives. Here’s how to get started as a clinical research associate.

1. Earn a degree.

To become a CRA, you’ll want to earn a bachelor’s degree in a health-related field. Consider a major in health sciences, nursing, medical technology, or biological sciences. Degrees in the humanities or social sciences, such as sociology or psychology, can also be helpful in providing a strong framework for research insights as a CRA. The degree should provide the foundation you’ll need to pursue clinical research associate and technician roles. 

2. Get certified.

While you do not need a certification to become a clinical research associate, having one can differentiate you from other candidates when it comes to being hired or promoted in this role. You can choose from certifications offered by two different organizations. 

The Association of Clinical Research Professionals (ACRP)

The ACRP offers the Certified Clinical Research Associate credential. To earn this certification, you must have one of the following:

A bachelor’s degree and at least 3,000 hours of experience as a CRA

A current CCRC, CPI or ACRP-CP certification and be able to substitute 1,500 hours of work experience

Completed a clinical research degree program and be able to substitute 1,500 hours of work experience

CCRA applicants must submit proof of their current job description and resume, and pass the CCRA exam. They must also complete 24 hours of continuing education, and be recertified every two years in order to maintain their certification. Through the ACRP, you can also become certified as a research coordinator, principal investigator, and clinical professional.

The Society of Clinical Research Associates (SOCRA)

The SOCRA offers the Certified Clinical Research Professional (CCRP) credential. To earn this certification, you must have one of the following:

At least two years of clinical research experience or 3,500 hours of part-time experience in the past five years

A degree in clinical research and at least one year of full-time experience

A certificate in clinical research, a bachelor’s or associate degree in health science, science, or a related field, and at least one year of full-time work experience

SOCRA applicants must pass the CCRP exam, and be recertified every three years. To become recertified, you’ll need to complete 45 hours of continuing education. 

The main difference between the certifications offered by SOCRA and ACRP is that ACRP only certifies clinical research associates, but SOCRA’s CCRP certification applies to other types of clinical research professionals.

3. Apply for jobs.

When you have the necessary qualifications to become a CRA, you can start applying for jobs. Visit job sites such as Indeed or LinkedIn and type in “clinical research associate” to search for entry or junior-level positions.

Looking for your first job? Read this: How to Get Your First Job: A Guide

Make sure to enhance your resume with any health care-related experiences you may have, including volunteer activities and internships. You’ll want to quantify your accomplishments with statements such as: “I managed clinical trials in seven different states in 2020.”

Prepare for interviews by researching the company and preparing your best answers. Don’t forget to write up a list of questions to ask your interviewer. 

4. Continue learning.

Going on to earn a master’s degree can help you land a managerial position or salary boost as a CRA. Clinical research associates are needed in many different types of organizations, so there are plenty of opportunities to achieve more interesting and dynamic job opportunities when you pursue higher education. 

Start your health care career with Coursera

Launch your career in the health care industry by honing your skills in medical terminology. You’ll be able to identify parts of words commonly used in medicine, understand health records, and more with the Medical Terminology specialization from Rice University.

Article sources

US Bureau of Labor Statistics. " Occupational Outlook Handbook: Medical Scientists , https://www.bls.gov/ooh/life-physical-and-social-science/medical-scientists.htm." Accessed September 13, 2022.

Glassdoor. " Clinical Research Associate Salaries , https://www.glassdoor.com/Salaries/clinical-research-associate-salary-SRCH_KO0,27.htm." Accessed September 13, 2022.

CNN Money. " Best Jobs in America, 4. Clinical Research Associate , https://money.cnn.com/pf/best-jobs/2012/snapshots/4.html." Accessed September 13, 2022.

Keep reading

Coursera staff.

Editorial Team

Coursera’s editorial team is comprised of highly experienced professional editors, writers, and fact...

This content has been made available for informational purposes only. Learners are advised to conduct additional research to ensure that courses and other credentials pursued meet their personal, professional, and financial goals.

Clinical Research Associate

Clinical Research Associate Certification

CRA Training Program

CRAs monitor clinical trial sites for compliance with guidelines and protocols. Salary of $60k to 120k+ based on experience level.

Requirement

A minimum of 4 year degree in science required though scientists, IMGs, nurses, prior coordinators, and even senior CRAs take our course.

Takes 2-4 weeks. Start today. Self-paced. 3k+ enrollees choose us because of our advanced curriculum with practice applications and competitive pricing.

Certification

Triple-accredited course with 17.5 CME. Achieve 70% on 2 attempts on MCQ exam.

Clinical Research Associate Training

Advanced Clinical Research Associate Certification (ACRAC)

Introduction

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

Roles and Relationships in Clinical Trials

Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Communication between Blinded and Unblinded Staff

Contract Research Organizations (Delegation, Responsibilities, Management )

Sponsor and Investigator Roles

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

ICH GCP - Overview

An Introduction to Clinical Research

An Overview of ICH GCP

ICH GCP - Ethical Research in Vulnerable Populations

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Prisoners

Ethics of Research Involving Pregnant Women and Fetuses

Adverse Events

Advanced Review of Adverse Events

Clinical Trial Protocol

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

IRB and DSMB

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Review Questions

REVIEW: Review Questions for ICH GCP (for study purposes, not graded)

Site Monitoring Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site Qualification Visit (SQV)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Site Initiation Visit (SIV)

Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

Routine Monitoring Visit (RMV)

Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

Site Close-Out Visit (SCOV)

Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

Tools for Monitoring Visits

Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

FDA Bioresearch Monitoring Program (BIMO)

FDA Warning Letter

Audits and Inspection Review Questions (for study purposes, not graded)

REVIEW A: Quality Monitoring Review Questions (for study purposes, not graded)

SDV and Informed Consent

ICH GCP Section 4.8 Informed Consent

Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

Minimizing Source Data Queries In Clinical Trials

Case Report Form

Guidelines for Designing and Completing Case Report Forms

Do’s and Don’ts of a Case Report Form Design

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

ICH GCP - Trial Management, Data Handling, and Record Keeping

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Clinical Trial Management System-CTMS

Electronic Data Capture and Remote Data Capture Basics

Electronic Regulatory Submission and Review

Modernized Monitoring (Remote, Risk-based, Centralized)

An Overview of Remote Monitoring - COVID-19 Update

Remote Monitoring of Clinical Trials and EMRs

Centralized Monitoring

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

REVIEW PART B: Quality Monitoring Review Questions (for study purposes, not graded)

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

CFR 21 Part 11 - Electronic Signatures

Code of Federal Regulations

CFR 21 Part 11

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

Regulatory Training Quiz

Disclosures and Payments for PI, Site, Patients

Financial Disclosure- Duties and Strategies for Clinical Studies

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Misconduct and Fraud

Scientific Misconduct and Fraud

Detecting Falsification

REVIEW PART C: Quality Monitoring Review Questions (for study purposes, not graded)

Site Visit Templates

SQV Checklist

SQV Questionnaire

SQV Assessment

SQV Follow Up Letter

SIV Confirmation Letter

RMV Confirmation Letter/Fax

RMV Follow Up Letter

CRA TRANSITION Letter/Email/Fax

SCOV Confirmation Letter

SCOV Agenda

SCOV Report

SCOV Follow Up Letter

REFERENCE Module

Final Examination

Competency Exam

Start Today

• Monitor Trial Sites
• Preferred 4 Year Science Degree or RN License or Prior CRC
• Salary $60-120k+. High promotion rate.

CCRPS Reviews

Accelerated, zehra abbas.

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with histo...

Accelerated course but really concentrated. Practical and clearly explained. Perfect alternance of slides/lecture videos. Easily understandable by with history background and by other as well with thehelo of the slides.

Mary Dahodu

Great course with high knowledge impaction. Platform also was easy to navigate.

Dedication to real material

Asra feroze.

The diligence and direction provided by this course material has inspired my inner confidence to climb high to reach the pinnacle of my ambitions.

Refreshed my knowledge after 10 years in monitoring

Dr. sharib syed muhammad.

Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.

a fundamental stepping stone for all monitors

George grudziak.

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn ...

If you want to move up the ladder in clinical trials, this is the best course to take. It’s so affordable even though I’ve paid three times as much to learn what is covered in just a chapter. I refer back to the course every time I switch to a new trial to refresh my knowledge.

CCRPS trains monitors to succeed in remote and local site...

Esohe ayanru.

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to m...

I was recommended to take the course by a friend who was transitioning to clinical trials. I had only worked in remote trials as a CRC before but wanted to move up. This course was so advanced and really made sure you understood all the core guidelines and monitoring report processes. It made me feel much more comfortable when applying for new jobs.

Phd In Monitoring

Adriana paz mancia.

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...

Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

two weeks to update your resume

Shivani dhotre.

CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.

Detailed Information

Oladipo owoyomi.

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, hi...

This is one of the best courses i have ever done. Despite being online, the engagement was topnotch. Participation was of high standard and the knowledge, highly inspiring. I recommend it for anyone with a research drive.

A great review of clinical research for monitors

Jayant shrivastava.

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...

I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.

Learn by examples. Great follow through videos.

Abiodun adegbite.

Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.

Lifechanging for my career

Latoya munroe.

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...

The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

How to become a clinical research associate

To become a clinical research associate, you must first complete an accredited clinical research associate training program. The course provides an extensive review of the regulations and principles of clinical research, as well as practical application of the skills needed to execute and manage trials correctly.

Clinical research associate certification test covers topics like clinical research protocols, FDA regulations, Good Clinical Practice (GCP), ICH guidelines, data management and more. If you pass the exam, it means you're certified as a CRA.

You can get clinical research associate training online free with webinars, tutorials, eBooks and other materials related to the profession. This can help you learn more about the job before you get certified.

What is a clinical research associate

A CRA makes sure clinical trials are done correctly and on time. They make sure the clinical trial follows the plan, good clinical practice guidelines, ethics, and laws. CRA's must know a lot about trial protocols, patient safety, data integrity and regulatory requirements to guarantee the quality of a clinical trial.

Clinical Trial Associate

A clinical research monitor will review study sites' data collection processes to ensure that all data collected is complete and accurate. This includes conducting on-site visits to assess study sites' compliance with good clinical practices (GCP), review case report forms (CRF), and periodically audit research sites to ensure compliance.

Clinical Trial Monitoring

Clinical research associates do things like teach the protocol; talk to human subjects and their families; get ready for investigator meetings, trainings, documentations; manage study supplies inventory; track subject enrollment, visits, data reports, study timelines; and solve any problems that come up during the study.

Why get clinical research associate training

Clinical trial monitoring job growth.

Getting certified as a Clinical Research Associate (CRA) gives you the opportunity to start earning salaries of up to $100,000 and 33% of new CRAs receive promotions within the first year.

Clinical research association accreditation

The ACRAC training program is internationally accredited by industry standards including IAOCR, ACCRE, AMA, ACPE, ANCC to provide comprehensive training for those holding at least a BA in Science.

Fast track clinical research training

Flexible online training and on-demand video modules that can be completed in as little as 2 weeks for a clinical research associate fast track career.

Clinical Research Associate Salary

Salary for clinical research associate

Clinical research associate salary (CRA) is typically higher than the national average and varies depending on experience, job title, city of employment and industry. The average annual salary for a CRA was estimated to be $80,000 in 2024.

Entry-level clinical research associate salaries can range from $47,000 - $80,000 per year. As a CRA gains more experience and furthers their education, they may be able to negotiate higher salaries due to their valuable knowledge and skills.

can exceed $90,000 in certain geographies or with specialized skillsets. Generally speaking, the higher the level of education or specific certifications held by a CRA, the higher salary they can expect to earn.

Various factors impact how much a CRA can earn such as their employer’s size and industry sector (pharmaceuticals vs biotechnology companies), amount of travel required for research responsibilities and tasks assigned.

Clinical research associate job description

What does a clinical research associate do

Developing Protocols and Case Report Forms

The Clinical Research Associate is responsible for creating clinical research protocols and Case Report Forms. This includes writing instructions, outlining procedures, collecting data, assessing collected samples/specimens, and making sure people follow the protocol/investigational plan.

Monitoring Clinical Study Sites and Teams

The CRA role includes making sure that sites are monitored, data is accurate, and reviewing source documents. They also manage a team of physicians, nurses, support staff (if applicable), vendors (such as laboratories) involved in the clinical trial and providing training on protocol requirements in order to achieve successful outcomes from each trial/study conducted.

Ensuring Regulatory Compliance

CRAs need to make sure they follow all the rules and regulations for conducting studies. This includes making sure the studies are safe for patients, ethical, and accurate. CRAs also need to attend regular meetings with people who are involved with the study to discuss any changes in the rules or regulations that could affect how the study is conducted.

Clinical Research Associate Jobs

How to obtain a CRA job

Utilize online job boards, such as Indeed and Glassdoor, to search for open positions. When searching, use keywords such as "clinical research associate jobs", "clinical research associate job", "clinical research associate jobs entry level" and "remote clinical research associate jobs". Make sure to write a cover letter.

To find potential employers as a Clinical Research Associate, look in directories of medical companies or local businesses.Contact the employer by email or phone and tell them why you would be good for the job they are trying to fill.

Talk to people who have jobs like the one you want, follow professional organizations on LinkedIn, and go to events where you can meet these people. This way, you might hear about job openings.

Check social media for job postings by following accounts related to Clinical Research Associates and checking them regularly for new postings that might be a good fit for you.

Clinical Research Associate Certification FAQs

Clinical research associates (CRAs) are professionals who work in the pharmaceutical and healthcare industries to manage clinical trials and collect evidence. The primary role of a CRA is to ensure that all clinical trials and research studies are conducted according to legal requirements, ethical standards, and good clinical practices. CRAs interact with other healthcare professionals, researchers, patients, and sponsors to coordinate activities related to the trial. A successful CRA must have a strong background in science and medicine, as well as solid communication skills. Candidates for CRA jobs typically undergo training on Good Clinical Practices (GCP) prior to beginning their job duties. Clinical research associate roles include but are not limited to recruiting subjects for studies; designing protocols; performing administrative tasks such as budgeting; coordinating data collection; providing feedback on documents; conducting site visits; monitoring safety reports; reviewing patient records; preparing reports; analyzing data from clinical trials; maintaining records of trial progress; managing study databases; and developing clinical trial databases.

1) Spearhead the planning, implementation and evaluation of clinical studies by preparing study protocols, developing case report forms and managing data collection. This includes creating regulatory documents such as informed consent forms, patient diaries and Investigator's Brochures. 2) Monitor study progress with sites to ensure compliance with protocol requirements and regulations, such as Good Clinical Practice (GCP). Review raw data, verify accuracy and completeness of case report forms, analyze data using statistical software packages and participate in final report preparation. 3) Participate in the selection of sites for trials while maintaining professional working relationships with investigators. Generate metrics from study results and attend investigator meetings to provide target product profiles/project plans that align with organizational objectives.

1) Prepare study documents such as protocols, informed consent forms, case report forms and investigator brochures 2) Monitor sites to ensure compliance with study objectives, protocol requirements, good clinical practices (GCPs) and applicable governmental regulations 3) Ensure the accuracy of subject enrollment, data collection and handling processes 4) Oversee the maintenance of accurate source documents and regulatory binders 5) Manage investigator payments according to contract terms 6) Train site personnel on protocol and GCPs requirements 7) Track necessary regulatory documents such as licensure/DEA/IRB approvals; resolve any related issues with IRBs or other regulatory agencies. 8) Lead study start up activities including sending out essential materials to sites, distributing and completing required training for staff members; verifying that site initiation visits are completed timely 9) Prepare monitoring plans in consultation with the sponsor or CRO leadership; perform pre-study, initiation, interim and closeout visits at investigative sites as per study timelines. 10) Perform remote monitoring activities by regularly reviewing case report forms (CRFs), checking query log resolution status from sites. 11) Provide guidance on data entry queries from clinical research coordinators (CRCs) or other site personnel. 12) Monitor safety events reported by sites; notify appropriate parties promptly regarding serious safety events or protocol deviations. 13) Ensure that all adverse event reports are followed up for completion by review of medical records. 14) Generate routine visit reports using standard CRF formats; track budgets for each site according to protocol specific requirements & perform final reconciliation of monies within sponsor's payment system.

1) In order to become a Certified Clinical Research Associate (CRA) with CCRPS CRA certification, the first step is to research and obtain an undergraduate degree in any field related to clinical research, such as public health, healthcare administration or epidemiology. 2) Prospective CRAs should strive to gain experience in a clinical research setting through volunteer positions or internships within hospitals, clinics, universities or pharmaceutical companies. 3) The next step is to take and successfully pass the Certified Clinical Research Associate (CRA) exam offered through the Certified Clinical Research Professional Society (CCRPS). This comprehensive examination covers topics such as Good Clinical Practice (GCP), study design and implementation, regulatory compliance and ethics.

•CCRAs have a more standardized set of skills, which can help with advancing their career and obtaining higher salaries. • Becoming a CCRA provides greater opportunities for job advancement and the potential to improve salary. • Additionally, CCRA certification is a great way to demonstrate expertise, stay on top of industry developments, network within the field, and have access to exclusive resources.

1) Become an expert in clinical research studies. Take the time to learn as much as possible about different types of trials, protocols and procedures, as well as the regulations governing clinical research. Additionally, take advantage of any available continuing education opportunities and seminars to stay up-to-date on the latest developments in the field. 2) Develop strong organizational skills to effectively manage multiple studies, sites and deadlines. Create a system for tracking tasks and deliverables so that nothing falls through the cracks – this will keep sites, sponsors and investigators happy and maintain your reputation for excellence. 3) Establish yourself as a reliable source for knowledge both inside and outside your organization. Keep abreast of current trends in the industry so you can offer advice to others or answer their questions promptly; gain recognition by authoring publications or presenting at industry events; and always make sure your work is accurate and follows all applicable regulations.

1. PRA Health Sciences: A global biopharmaceutical organization that provides contract research services and drug development solutions to pharmaceutical, biotechnology, and medical device companies. 2. Syneos Health: A clinical services organization delivering integrated, tailored solutions to help customers accelerate the delivery of therapies to market with confidence. 3. IQVIA: A leading provider of integrated information and technology solutions for healthcare and life sciences organizations, helping them drive efficiency and effectiveness across all aspects of their business. 4. ICON Clinical Research: Providing strategic development advice and clinical trial execution services from a network of highly qualified site personnel across 63 countries. 5. Covance: A contract research organization (CRO) providing drug development solutions from laboratory testing services through to large-scale clinical trials in more than 25 countries worldwide 6. Chiltern International Ltd.: An award-winning CRO that offers full-service clinical development capabilities such as legal compliance support, project management, medical writing, data management/statistical analysis, safety/pharmacovigilance monitoring and global regulatory submissions assistance for clients in the US, Europe, Asia Pacific, South Africa and Latin America. 7. BioClinica Clinical Trials Solutions: Offering comprehensive eClinical suite that helps streamline processes related to study design, document management & reporting as well as imaging & safety data collection & review process management in real time around the globe for all types of studies—Sponsor-initiated Protocols (SIPs) or Investigator Initiated Studies (IIS). 8. Worldwide Clinical Trials: An award-winning CRO providing comprehensive clinical trial operations & data management services from initial concept development through final report generation across multiple therapeutic areas including oncology & rare diseases for both early phase studies & late phase trials in over 28 countries around the globe. 9. Clinipace Worldwide Clinical Trials Services: Specializing in creating innovative technology platforms for clinical research by combining its expertise in digital media with its deep understanding of regulatory policies thereby helping reduce complexities associated with managing large scale global projects involving multiple stakeholders from different parts of the world from start to finish – protocol design & buildout; patient enrollment & retention; site training; EDC builds; study closeout activities etc., involving both electronic data capture (EDC) based studies as well as non EDC based studies which can be delivered simultaneously or independently depending upon customer's requirements/goals at any one given point in time during the life cycle of a clinical trial project globally - US/EU/ROW markets etc., while adhering to the highest standards of quality assurance (QA), timelines and budget requirements resulting into improved operational efficiencies on part of our customers leading to better ROI figures towards end results achieved by successful completion of projects within stipulated timelines without compromising on Quality whatsoever!

1. Clinical research associates typically make an average of $53,000 a year, with a range between $45,000 to $62,000 annually. 2. The top 10 percent of clinical research associates can expect to make around $70,000 or more annually. 3. The lowest 10 percent of clinical research associates earn around $40,000 or less per year. 4. Mid-level salaries for clinical research associates usually fall within the range of $50,000 to $60,000 annually. 5. Incentives such as bonuses and commissions can significantly increase overall earnings for experienced clinical research associates. 6. Geographical location is often a factor in determining salaries for this profession; locations that tend to pay more include states like New Jersey, California and Massachusetts as well as metropolitan areas such as Seattle and San Francisco. 7. Other factors that may influence how much a clinical research associate earns include experience level and sector of the industry they are employed in (i.e., government, private or academic). 8. A career in this field offers many opportunities for growth and financial advancement; with additional education or certifications an individual could potentially make upwards of six figures annually after several years of experience in the profession.

Clinical Research Associate Course Syllabus

The CCRPS CRA program contents meets AMA requirements for 17.5 CME. This means that the course can help you succeed in your medical career. Additionally, the introductory chapter introduces you to clinical terminology and abbreviations commonly encountered in clinical research.

As a clinical research associate (CRA), it is important to know how to interact with other stakeholders in order to set up and monitor clinical trials for an investigational product or IP. These stakeholders include the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC), other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

The ICH-GCP guidelines provide procedures and precautions for protecting human research participants during clinical research. These guidelines cover obtaining informed consent from human subjects, maintaining trial records, reporting compliance and progress, as well as procedures for suspending or terminating trials. The chapter also covers the importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

This chapter will teach you about the different phases of clinical trials, from the pre-clinical phase to Phases 0-4. You will learn about important concepts like the structure and goals of each phase, dosing approaches, toxicology testing, and more. The chapter will also review the FDA's drug approval process.

The chapter provides an overview of GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

In chapter 6, we will learn about ethical research involving vulnerable populations. This includes people who are pregnant, children, mentally incapacitated individuals, and prisoners. We will learn about the challenges of conducting research with these groups of people, including obtaining consent from parents or guardians, providing fair incentives, and using deception or incomplete disclosure in a justified way.

This chapter covers the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8 is all about clinical trial protocols (CTPs). This chapter goes into detail about what a CTP is and how to write one. It also covers important concepts like study risk benefit analysis (RBA), sample size and statistical power, data analysis, risk management, and study administration. Additionally, the chapter addresses concepts related to choosing participants for the study, including inclusion and exclusion criteria, safety concerns, and ethical considerations.

This chapter will teach you about protocol deviations and violations. You will learn about the different types of deviations and violations, and how to distinguish between them. You will also learn about the most common violations, including minor ones (like off-schedule subject assessments) and major ones (like failure to report AEs). Finally, the chapter will review principles for reporting protocol deviations and IRB approval for planned deviations.

The IRB (Institutional Review Board) and DSMB (Data Safety Monitoring Board) are responsible for reviewing and approving research studies involving human subjects. This chapter reviews the history of these boards, and discusses the principles that guide their decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

This module provides an overview of different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

This chapter provides a thorough understanding of the stages and steps involved in selecting a study site. The module reviews elements such as the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). It is important to learn about the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

This module goes into detail about site initiation visits (SIVs). You will learn how to prepare for an SIV, including what approvals, permits, and licenses you need. Additionally, the module covers what should be on the SIV agenda, such as orientation and training for site staff. Finally, you will learn about post-SIV procedures, such as filing compliance documents like FDA form 1572 and Financial Disclosure Form (FDF).

This unit will teach you about routine or periodic monitoring visits. You will learn about the agenda of an RMV, which includes receiving updates on AEs from site staff and overseeing the progress of trials. The unit covers different approaches to site monitoring, including traditional (full-scale) monitoring and risk-based monitoring (RBM). It also compares on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is essential for obtaining accurate data from clinical trials.

This chapter covers everything you need to know about ending or finishing a trial site. This includes things like notifying the IRB and coordinating schedules among site staff (PI, other investigators, medical staff) and the monitoring team (CRC, CRAs, etc.), as well as preparing for an SCOV meeting – drug inventory management, database verification and lockdown, subject notification and completion of all subject-related documents, staff-related documentation, and other administrative tasks like compiling a close-out report.

This unit provides tips and tools to help a CRA (clinical research associate) effectively monitor clinical trials. The chapter lists physical accessories that can be useful for monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

This module will help you understand and prepare for audits and inspections by the CRO, FDA, or other regulatory authority. It covers the difference between an audit and an inspection, and provides detailed protocols for both. Additionally, it outlines the sequence of an FDA inspection, including a walk-through of the Biomedical Research Monitoring Program inspection. You will learn about important audit and inspection documents, such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation). You will also learn about the Establishment Inspection Report (EIR) prepared by the auditor/inspector. Finally, you will understand the different types of observations in an EIR, including NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated).

This chapter discusses the ICH-GCP guidelines on obtaining informed consent from subjects. The highlights include the need to use non-technical language, transparently delineate risks, obtain consent without undue influence, obtain consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to ensure that subject trial data (as recorded in Case Report Forms or CRFs) correspond to source data (previous medical records).

This module provides a detailed overview of the structure and elements of a Case Report Form (CRF), including different forms for Principal Investigator (PI) verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events, etc. Additionally, the chapter outlines important data notation rules, such as the use of accepted acronyms (e.g., ‘ND’ for missing data and ‘UNK’ for unknown information), MM-DD-YY format, time-stamp data, etc., as well as guidelines for the design of CRFs (e.g., consistency of notation, avoidance of duplicate data fields).

In this unit, you will learn about Quality Control in clinical trials. This includes understanding what Quality Control is, its relationship with Quality Assurance, using Key Performance Indicators, having a Corrective and Preventive Action plan, and more. Additionally, the module will look at the QA process, focusing on risk-based monitoring and providing guidelines on Quality Metrics. The chapter also reviews ICH-GCP guidelines on subject safety, including risk-benefit assessment and stoppage rules in case of serious adverse events. Finally, it introduces the FDA’s Human Research Protection Program.

This tutorial provides an in-depth look at the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs), including IVRS and IWRS, as well as RTSM systems for Randomization and Trial Supply Management are examined. The benefits of standardized data management and data sharing, approaches to database management, and the concept of an Independent Data Monitoring Committee (IDMC) are reviewed. Critical elements of data integrity, such as proper anonymization and coding, completeness of data, data safety precautions, and logging of site visits and other progress reports are highlighted Essential features of a good Clinical Data Management(CDM) system that complies with FDA CFR Title 21and HIPAA regulation.

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements.

This unit will teach you about pharmacovigilance (PV), which is the process of monitoring the effects of drugs. You will learn about the statistics on adverse events (AEs), how to distinguish between Type A and Type B AEs, and how to assess the severity and probability of an adverse drug reaction (ADR). This unit also covers Individual Case Safety Reports (ICSRs) in detail, including their structure, content, and role in trial monitoring. Other topics include types of PV inspections, periodic safety update reports (PSURs), and study criteria for instituting data safety management boards (DSMBs).

In this chapter, we provide a detailed review of the protocol for receiving, storing and dispensing the investigational product (IP). At every stage, there are guidelines in place to ensure the safety of study subjects and staff. This includes handling the IP with care, logging relevant information such as date of manufacture and batch number, and recording shipping details. Additionally, we address the need for precautions when dispensing the IP, such as limiting access to authorized personnel only.

This section looks at how lab testing in clinical trials has changed over time. It used to be done in local labs, which had a lot of mistakes. Now it is done in central labs, which makes it more accurate and reliable. The section also covers standards for clinical trial laboratories, such as the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments). Additionally, it provides guidelines for lab audits, including fire safety and staff training.

The chapter reviews essential documentation that needs to be created and maintained throughout the clinical trials. This includes the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312. You will learn about each of these forms and why it is important to keep records updated, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. The unit also requires that you submit documents that describe the procedures for the study and site, including an SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR). This includes Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56), Series on food (100), pharmaceuticals (200 and 300), as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES). Part 11 lays down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

This module will cover the process of how drugs are evaluated by the FDA, and the role of a CRA in this process. You will learn about the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The criteria for evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, you will learn about FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

In this chapter, we will discuss FDA guidelines regulating financial disclosure in depth. This will cover the definition of 'conflict of interest' and the stipulations of Title 21 Section 54 on disclosure requirements. We will also study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on 'fair market value' as well.

The chapter also talks about things that might make it hard to meet recruitment goals, and how to make it easier, like being less picky about who can join, giving people money to cover travel costs, and making it clear what benefits come from participating. The unit also covers why patients might leave a trial early, and how to prevent that from happening as much, like making the experience better for patients (by paying more attention to them and being flexible with when they can come in for visits, etc.), and using technology to make things simpler and more efficient (like having digital forms that can be completed automatically). Finally, the unit discusses some new ways of keeping patients involved and compliant in clinical trials; these techniques use technology to get better results.

This module discusses reasons why people might commit scientific fraud, and the consequences of fraudulent practices in clinical trials. A scale is presented for classifying errors in clinical trial data. At one end of the spectrum is ‘honest, isolated mistake’ and at the other end is ‘deliberate data falsification with malicious intent’. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will learn how to identify signs of fraud during the actual clinical trials process.

Your session is about to expire

Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

Other Trials to Consider

Treatment as usual

Creating peace, strengthening connections for change, experimental: maintenance of certification (moc), vlpfc-pcc stimulation, in-person (or remote) intervention, driven app-based program, intervention, communication skills training, experimental group (wstp), popular categories.

DCIS Clinical Trials 2024

Clinical Trials in Houston, TX

Clinical Trials in Seattle, WA

Clinical Trials in Sacramento, CA

Clinical Trials in Greensboro, NC

Clinical Trials in Texas

Clinical Trials in Illinois

Paid Clinical Trials in San Diego, CA

Clinical Trials in Montreal, QC

Achromatopsia Clinical Trials 2023

Popular guides.

• Technical Help
• CE/CME Help
• Billing Help
• Sales Inquiries
• CE Certificates
• Billing Inquiries
• Purchase Inquiries

Premier Episode of On Research Podcast – What is a Clinical Research Associate?

Season 1 – Episode 1 – What is a Clinical Research Associate?

A Clinical Research Associate (CRA) is a professional within a healthcare setting who oversees research activities, typically related to clinical trials. CRAs can be employed and work in a variety of sectors, including government agencies, pharmaceutical companies, research institutions, and in similar settings. Most CRAs possess an academic degree from a higher education institution in a field related to the healthcare industry. The overall role and tasks of a CRA are outlined and defined by good clinical practice guidelines for clinical trials.

Episode Transcript

Darren Gaddis : From CITI Program, I’m Darren Gaddis and this is On Research. Today, what is the difference between a clinical research associate and a clinical research professional? The skills and training needed to be a clinical research associate and general misconceptions about clinical research associates. I spoke with Elizabeth Waddell, owner and CEO of the CRA Helper.

She has been in the clinical research industry for over 20 years. Elizabeth began her career as an in-house clinical research associate and later transitioned to an on-site clinical research associate. After 14 years as a monitor, she transitioned from a senior clinical research associate to a line manager role focused on training new CRAs.

As a reminder, this podcast is for educational purposes only. It is not intended to provide legal advice or guidance. You should consult with your organization’s attorneys if you have questions or concerns about relevant laws and regulations discussed in this podcast. Additionally, the views expressed in this podcast are solely those of the presenter.

Hi Elizabeth. Thank you for joining me today.

Elizabeth Waddell : Hi Darren. Thank you so much for having me. I’m excited to be here.

Darren Gaddis : To get us started, what is a clinical research associate or CRA?

Elizabeth Waddell : So a clinical research associate, like you said, A CRA, and they’re also known as a monitor. I think the best way to explain what it is, is to start with why is it even required.

So per FDA regulations and GCPs, the sponsor must ensure that the clinical trials are properly monitored and this is to ensure the rights and the wellbeing of the human participants are protected, and they have to make sure the patients are safe. And on the flip side, they need to make sure, and ensure that the data from the clinical trial is accurate, complete and verifiable from source documents. And that the study’s being conducted in compliance with the protocol GCPs and reg requirements. So there’s a lot they have to monitor in a trial and that’s where we come in, that’s where the CRAs come in.

We must monitor the studies on behalf of the sponsor. And our two major obligations are ensuring subject safety and data integrity. And there’s even guidance regarding the selection of CRAs, as we must be qualified by the training and experience to monitor the progress of the trial. So it’s a very important role, as keeping patients safe and protected is so huge. And also verifying the validity of the data is huge, because for example, in a pharmaceutical trial, the FDA is reviewing this data to evaluate if a drug is safe. They’re evaluating if the drug is effective and that’s going to go into all that decision-making if a drug is approved or not. So it’s very important, monitoring the progress of a trial.

Darren Gaddis : And from that definition, what is the difference between a clinical research associate and clinical research professional?

Elizabeth Waddell : So a clinical research professional to me, is anyone in the clinical research industry. So a CRA would be an example of a clinical research professional. It’s one of the roles in the industry. There are so many roles as you’ll see from project managers to auditors to clinical trial associates, and then you have roles at the site level as well.

Darren Gaddis : From your own experience, could you describe the training and skills that one needs, to be successful as a CRA ?

Elizabeth Waddell : So I’ll start with the training. When we would review CVs, a curriculum vitae, it’s like a resume in the research world. When we would review CVS in order to interview a potential CRA candidate, we primarily looked at their education, as well as their clinical research experience.

So taking a CRA training per se, wasn’t something that was required. Again, we focused on the clinical research experience. Now, although a CRA training course is not required though, can it help build confidence? Absolutely.

So for example, when I was assigned to a study that was a new therapeutic area, in addition to training at our company, I would take extra trainings to build confidence when monitoring the disease under study. So it’s the same thing with a CRA training course that may not be a requirement to get the job, but if it can help you learn and build the confidence to perform the job better or even interview better, it is so worth it.

And the same thing, even certification being a certified CRA, it wasn’t necessarily a requirement for me, I didn’t have to be certified and actually I did my certification, or obtained it when I was a senior CRA.

My company offered, they were like, “Hey, we’ll pay for it, you have the time. Do you want to go for it?” And I’m like, “Oh my gosh, yeah that would be awesome!” So I did do it, and it’s an accomplishment for sure, and I’m glad to have it and I’m glad to have the credentials. But did I have to be certified to get a CRA job? I did not. So I do like to point that out. Definitely, clinical research experience on a CV speaks volumes, but again, you do the training more for yourself to help build that confidence.

As far as skills required, definitely, attention to detail. You will go through documents like a fine tooth comb, you definitely need to have those eagle eyes, attention to detail, and definitely critical thinking skills, because in research you’ll find that not a lot of things are black and white. It takes critical thinking, problem-solving, sometimes escalating things to different study team members.

I’ve been in research for 20 plus years and I still send emails like, “Hey, I’ve noticed this. This is what I’m thinking of, how to resolve the issue, what are your thoughts?”

And sometimes you have to consult with different departments. Not being afraid. Do not be afraid to ask questions. Again, like I talked about, you’re going to confirm things with different departments sometimes. And to me, asking questions is not a sign of weakness, it’s a sign of strength, because you want to do your job, you want to confirm things for your study.

And you definitely need to have time management skills, there are a lot of deadlines and metrics that you must meet, so definitely time management, being able to prioritize, and then being able to reprioritize, because there’s many times things are changing in clinical research, you may get an email that totally changes your day. So you’ll have to reprioritize what needs to be performed for that day. And like I mentioned, being able to adapt, being flexible, so these are some soft skills that you’ll need to have as well, as deal with different personalities.

Very important, as you’ll be not only with your study team, but you’re going to be going to many different sites and interacting with different people and things, so that’s important to have as well as being able to be organized, being able to work independently because again, you’re going to many sites working by yourself there, monitoring documents, as well as sometimes when you’re not on the road, you may be working remotely, at home in your office.

So you have to be able to still meet your deliverables, work independently and be able to communicate effectively. And not just verbally, but written communications is very important. Lots of trip report completion, email communication, lots of documentation as a CRA, so definitely written communication is so important. And I know there are many more skills I could probably point out, but I would say this is a good start of important skills to have.

Darren Gaddis : And with all of this in mind, would you be willing to share your own journey to becoming A CRA ?

Elizabeth Waddell : Yeah, sure. I graduated with a bachelor’s in clinical research, and while I was doing my internship, I interviewed to work in the lab actually, at a company that manufactured vaccines. And I was offered the job, but at the same time I received a call from a recruiter with an opportunity as an entry level in-house CRA, and I was like, “Oh wow, this is clinical research…”

My heart was just being tugged in that direction, and it ended up that I chose the in-house CRA opportunity and it was definitely a blessing. I first was contract, then I went permanent, and after about a year of being an in-house CRA, a CRA 1, I was promoted to a CRA 2, and then moved to the clinical department and started onsite monitoring. And the rest is history, here we are 20 years later.

Darren Gaddis : And from your own tenure, what is one general misconception about CRAs?

Elizabeth Waddell : In my experience, I would say one of the misconceptions about CRAs I would see, is people would picture, “Okay, CRAs, they come to a site and their role is to go to the site and pick them apart.”

And although sometimes I would, I’d be at a site and I’d see another monitor come in, and maybe they would have this air about them, like high and mighty. And they wouldn’t nicely point out issues that they observe. Sometimes that happens…

But the truth is we are a team with the site. So even though I may go to a site and I’m monitoring the study and I’m reviewing charts and reg docs and study drugs… And yes, I may discover or observe an issue, there’s a way that we treat our sites, and a respectful way to point out observations and also reeducate them because we want to help them, we’re there to help.

We also should work together with a site as a team, having that same goal of subject safety and data integrity. So that’s definitely a misconception that people have because there’s not one role that’s higher than the other. You have the site level and then you have a CRA that’s either with a sponsor or a CRO, and again, we’re all a team doing this clinical trial together.

Darren Gaddis : How could someone get their start as a CRA?

Elizabeth Waddell : Well, most CRA positions require at least a bachelor’s degree and usually in a scientific area or a scientific discipline is preferred. This of course would depend on the company. In addition, most entry level CRA roles require about one to three years of clinical research experience. Again, that’s going to depend on the company, but clinical research experience, like I mentioned, speaks volumes on a CV, so some ways that people may gain this experience in order to apply for an entry level CRA position, they can gain this clinical research experience like me, maybe starting out as an entry level in-house CRA, and then move to onsite monitoring. Or they may gain experience as a clinical trial associate or a project specialist or project coordinator. And some may gain experience at the site level, as a research assistant, or a clinical research coordinator, and they’re also known as a study coordinator.

And I always say that in my experience, study coordinators make great CRAs. So some people gain experience that way, and others may start with even a clinical research internship and start getting that experience under their belt that way. So unless a company has a position where they have their own training program and they do not require previous research experience, which there’s not many that I’ve seen, most of the time the companies will require at least one to three years of that previous clinical research experience. So it’s definitely important to have clinical research experience under your belt.

Darren Gaddis : And what else would you like to share with us about CRAs?

Elizabeth Waddell : Clinical research is a blessing, and to be a part of, and being a clinical research monitor, CRA is so rewarding. And also there are so many roles that it can lead to in the industry, like becoming a lead CRA or project manager, or even if you want to manage CRAs like becoming a line manager or QA auditor, or like me managing and training new CRAs, which I absolutely love. So there is so much growth in the industry. So that’s another great thing about it.

Darren Gaddis : Elizabeth, thank you for joining me today. Be sure to follow, like and subscribe to On Research with CITI Program to stay in the know.

I also invite you to review our content offerings regularly, as we are continually adding new courses and webinars that may be of interest to you. All of our content is available to you anytime through organizational and individual subscriptions. You may also be interested in CITI Program’s, Clinical Research Coordinator courses. Please visit CITI Program’s website to learn more about all of our offerings.

How to Listen and Subscribe to the Podcast

You can find On Research with CITI Program available from several of the most popular podcast services. Subscribe on your favorite platform to receive updates when episodes are newly released. You can also subscribe to this podcast, by pasting “ https://feeds.buzzsprout.com/1896915 .rss” into your your podcast apps.

Meet the Guest

Elizabeth Waddell, BS, CCRA – The CRA Helper Owner/CEO of The CRA Helper. I provide online training based on 20+ years of clinical research experience in order to help others pursue a career as a Clinical Research Associate.

Meet the Host

Darren Gaddis , Host, On Campus Podcast – CITI Program

He is the host of the CITI Program’s higher education podcast. Mr. Gaddis received his BA from University of North Florida, MA from The George Washington University, and is currently a doctoral student at Florida State University.

• On Campus Podcast – AI in the Classroom (Part 1)
• CITI Program Media Playlist – April 17, 2024
• Person-First Language: Enhancing Respect and Inclusivity in Research
• What CITI Program is Reading – April 10, 2024

Privacy Overview

• Core Curriculum
• Web Seminars
• On-Boarding Programs
• On-Site Training
• On-Demand eLearning Courses
• Web Seminar Archives
• CCAD Programs
• GCP Training Assessments
• Mock Audits Findings Based Training
• Virtual Meetings Support Services
• Customized eLearning Solutions
• Licensing of Barnett's Content
• SOP Development Training
• Acquisition Integration
• Training Subscription
• Publications
• Course Catalog

• Training Courses
• GCP Training & Assessments
• Audits and Mock Inspections
• Licensing of Barnett's Content
• SOP Development & Training

Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

CRA & CRC: Beginner Program

Upcoming Courses

This course will be offered from 12:00 p.m. - 7:00 p.m. Eastern

Modal body text goes here.

Course Description

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC.

Learning Objectives

• Describe the investigational product development process
• Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practices (GCPs)
• Describe the roles and responsibilities of the Clinical Research Associate and the Clinical Research Coordinator before, during, and after a clinical trial
• Identify the requirements of the Investigator in supervising clinical research
• Discuss the role of an Institutional Review Board, its composition, and responsibilities in the clinical trial process
• Define the informed consent process, the elements of the informed consent document
• Describe an overview of the different types of Monitoring Visits, including preparation, activities, and monitoring visit follow-up
• Define source documents and Case Report Forms (CRFs) in relation to CRF completion and source document verification
• Describe definitions related to safety management, identification of adverse events, and reporting requirements
• Describe the difference between a sponsor audit and an FDA inspection and preparation

Who Should Attend

• Aspiring Clinical Research Coordinators and Nurses
• Aspiring Clinical Research Associates – In-house or Field-based
• College Students and New Graduates in a Scientific Field
• NOTE: This course is also appropriate for CRAs or CRCs with less than six months experience

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

• Introduction to Clinical Research
• Clinical Research Team: Roles & Responsibilities
• Investigational Product (IP) Development  
• Good Clinical Practice: FDA Regulations, FDA Guidance, and ICH GCP E6 Guideline
• The Clinical Study Protocol and Study Feasibility
• The Principal Investigator, Site Selection, and Study Initiation  
• Institutional Review Board, the Consent of Human Volunteers, and HIPAA  
• Safety Reporting: Definitions & Reporting Requirements
• IP Accountability, Essential Documents, and Routine Monitoring Visits
• Source Document Verification, Data Management, and the Trial Close-out Visit  
• Interactive Exercises I and II: CRF completion and monitoring simulation exercises
• Regulatory Compliance & Quality Assurance: Audits & Inspections

Interactive Activities

• Case Study Reviews – Adverse Events, Protocol Modifications, Study Feasibility, Informed Consent and Monitoring Visit Scenarios
• Site Selection, IP Accountability, Source Document Verification and Case Report Form Exercises

Registration Fees

Special rates are available for multiple attendees from the same organization.  Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: [email protected].

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 22.5 hours (2.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-004-L04-P. Released: 3/22. 

                Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

• MTS Health Sciences Clinical Research Certification – CCRA, CCRC, CPI
• Anesthesia Technician
• Audiologist & SLP
• Cardiovascular Technologist
• Dental Assistant
• Dental Hygienist
• Diagnostic Medical Sonographer
• Dialysis Technician
• EKG Technician
• EMT & Paramedic
• Kinesiologist
• Mammography Technologist
• Medical Assistant
• MRI Technologist
• Neurodiagnostic Technologist
• Nuclear Medicine Technologist
• Ophthalmic Technician
• Pharmacy Technician
• Phlebotomist
• Physical Therapist Assistant & Aide
• Psychiatric & Mental Health Technician
• Radiation Therapist
• Radiologic Technologist
• Respiratory Therapist
• Surgical Technologist
• Cytologist (Cytotechnologist)
• Dental Lab Technician
• Histotechnologist
• Medical Lab Assistant
• Medical Lab Technician
• Biological Sciences
• Biomedical Science
• Biotechnology
• Health Sciences
• Medical Laboratory Scientist
• Nutritionist & Dietitian
• Pathologists' Assistant (PathA)
• Pre-Vet (Veterinarian)
• Biomedical Equipment Technician
• Biomedical Informatics
• Health Informatics
• Health Information Management
• Health Information Technology
• Healthcare Administration
• Medical Billing & Coding
• Nursing Informatics
• Sterile Processing Technician
• Patient-Facing Technology Programs
• Laboratory Technology programs
• Natural & Clinical Lab Science
• Medical IT & Administrative

Certification Guides

Career guides, interviews & features, clinical research certification - ccra, ccrc, cpi, search for schools.

When you click on a sponsoring school or program advertised on our site, or fill out a form to request information from a sponsoring school, we may earn a commission. View our advertising disclosure for more details.

Gaining a clinical research certification can offer many benefits for those in the field. Earning a credential through a rigorous application review and test indicates to potential employers that the holder boasts specific experience and skills making him or her more likely to succeed in a given occupation.

In the case of clinical research, this is especially important since running clinical trials requires hands-on training and continued guidance to ensure compliance with long-established standards.

These clinical research professionals include varied roles, including clinical research associates (CRA), clinical research coordinators (CRC), and principal investigators (PI).

In sum, having a certification in one of these areas can provide the following advantages:

Enhances Professionalism – Certified clinical researchers and investigators can take their career to a more professional level by:

• Becoming well-grounded in a core body of knowledge defined by the certifying body
• Committing to the pursuit of knowledge in their area of expertise through ongoing professional development
• Gaining certification through assessment signifying they possess the knowledge and skills necessary to lead in their field
• Committing to follow a code of ethics as defined by the certifying body

Indicates Competence – Through certification, an applicant’s knowledge and skills as a qualified, ethical clinical researcher are validated by a third party. Certification verifies an understanding of international clinical research standards and the ability to apply those standards to the researcher’s profession.

Applies Quality Standards to the Profession – Certified clinical researchers commit to the protection of human subjects, compliance with research regulations, and the quality of the data they collect.

Sets a Professional Apart from Others – Researchers who gain certification show their commitment to quality, ethics, and international research standards which sets them apart from those without certification. Clinical research certifications prepare researchers for career advancement and greater responsibility as leaders in their field.

Can increase Salary – Certified clinical researchers also have the potential to earn more than their non-certified colleagues.

Arizona State University

Johns hopkins university (aap), university of west florida, become a certified clinical research associate (ccra).

Certifying Agency: The Association of Clinical Research Professionals (ACRP)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRA exam. Experience older than ten years will not be considered. See below for exam content details.

Up to 1,500 hours of work experience may be substituted for one of the following options:

• Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
• Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)

All applicants undergo a formal eligibility review process upon application.

Exam Details: The exam assesses proficiency in six core knowledge areas including:

Candidates must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRA Exam Handbook from the CRA Certification page under “About the Exam”.

• Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
• Exam Duration: Maximum of three hours
• Exam Delivery: Secure computer terminals
• Exam Language: English
• Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status and when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
• Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals must participate in 24 contact hours or points of continuing education and activities every two years. Alternatively, they may retake the certification exam.

Careers for CRAs: Clinical research associates are employed by sponsors from pharmaceutical companies, device companies, grant companies, universities, sponsoring physicians, or other entities. They serve in the role of an independent monitor in the administration and progression of clinical trials on behalf of the sponsor. CRA certification can advance a career as a:

• Clinical Research Associate
• Research Nurse
• Independent Consultant/Contractor

Become a Certified Clinical Research Coordinator (CCRC)

Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRC exam. Experience older than ten years will not be considered. See below for exam content details.

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRC Exam Handbook from the CRC Certification page under “About the Exam”.

• Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status as well as when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.

Careers for CRCs: Clinical research coordinators are employed by clinical research organizations under the direction of a principal investigator, who practices research under GCP guidelines. CRP certification can advance a career as a:

• Clinical Research Coordinator

Become a Certified Principal Investigator (CPI)

All CPI candidates must also provide proof of employment as a principal investigator (PI) or sub-investigator (sub-I) on two clinical trials.

Up to 1,500 hours of work experience and one clinical study PI or sub-I position may be substituted for one of the following options:

Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CPI Exam Handbook from the PI Certification page under “About the Exam”.

Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals may take the current certification exam or they must participate in 24 contact hours or points of continuing education and activities every two years.

Careers for CPIs: Principal Investigators hold a PhD or equivalent and are responsible for the ethical and safe conduct of clinical trials. CPI certification can advance a career as a Principal Investigator.

Become a Certified Clinical Research Professional (CCRP)

Certifying Agency: The Society of Clinical Research Associates (SOCRA)

Eligibility Requirements: Applicants must be working under Good Clinical Practice (GCP) guidelines and must meet one of the three following criteria sets:

• Two years of experience as a full-time clinical research professional or 3,500 hours of part-time experience during the last five years
• Associate, undergraduate, or graduate degree in clinical research and has a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional
• Undergraduate or graduate certificate in clinical research with no less than 12 semester credit hours or totaling 144 credit hours from an academic institution of higher learning; an associate or bachelor’s degree in a pharmacy, science, health science, or related field; and a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional

Applicants must submit an application, resume/CV, job description, verification of employment letter, and signed ethics statement.

Exam Details: The exam focuses on five content areas patterned after the 2017 SOCRA Job/Task Analysis. Examinees can download a detailed exam outline . Generally, candidates are tested on ethical principles, safety, informed consent; clinical trial protocol and amendments; institutional review board/ethics committee roles and responsibilities; investigator roles and responsibilities; and sponsor roles and responsibilities.

• Exam Format: 130 multiple-choice questions that assess understanding and application, 30 of which are beta testers and are not scored. Examinees must answer 72 of the 100 scored questions correctly to gain certification.
• Exam Duration: Maximum of four hours
• Exam Delivery: Paper and pencil format or computer-based testing
• Paper/Pencil (Members: $395, non-members: $450)
• Computer-Based Testing (Members: $395 + $115 within North America, +$175 outside North America, non-members: $450 + $115 within North America, +$175 outside North America)
• Exam Dates: Paper and pencil format dates run throughout the year in various locations. Computer-based testing is determined once the application is approved.

Renewal Process: Certification is valid for three years and must be renewed by application . CCRPs must complete 45 hours/credits of continuing education during this period, 22 of which must be related to clinical research. The other 23 hours may concern the professional’s specific career path. The fee to renew is $350.

Careers for CCRPs: Because clinical research professionals come from various professional paths, CRP certification can help advance careers in medical technology, nursing, statistics, biology, teaching, health records, administration, pharmacy, and other careers.

Become a Certified Research Administrator (CRA), Certified Pre-Award Research Administrator (CPRA), or Certified Financial Research Administrator (CFRA)

Certifying Agency: The Research Administrators Certification Council (RACC)

Eligibility Requirements: Candidates must comply with one of the following criteria sets:

• Holds a bachelor’s degree and has three years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
• Holds an associate’s degree and has five years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
• Has six years of professional experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization; candidates falling into this category must complete a petition application including two letters of reference

The third option is only available through a special petition process and each petition is evaluated on a case-by-case basis.

Exam Details: The questions for each type of exam are obtained from previously certified individuals in those fields (CRA, CPRA, and CFRA). Exam sections consist of varying topics depending on the certification and include some of the following: project development and administration, legal requirements, research partnership and funding, project costs, fiscal compliance, and more.

• Exam Format: CRA (200 multiple choice questions); CPRA (250 multiple choice questions); CFRA (200 multiple choice questions)
• Exam Delivery: Computer-based testing at certified PSI testing facilities
• Exam Fees: $395
• CRA: Spring – May 11 to May 25, 2024; Fall – November 2 to November 16, 2024
• CPRA: Spring – February 17 to March 2, 2024; Fall – August 17 to August 31, 2024
• CFRA: Spring – March 2 to March 16, 2024; Fall – September 7 to September 21, 2024

Tests are administered Monday through Saturday during the outlined two-week exam windows at various PSI locations throughout the U.S. and Canada.

Renewal Process: Certification is valid for five years. Renewal for another five years follows these requirements:

• CRA recertification requirements include 80 hours of continuing education, either taken or taught, or activities participated in, and three questions for use on a future certification exam. Educational activities include a variety of options as defined by RACC.
• CPRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related to pre-award activities; or by retaking and successfully passing the CPRA exam.
• CFRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related specifically to financial activities; or by retaking and successfully passing the CFRA exam.

Become a Certified Clinical Data Manager (CCDM)

Certifying Agency: The Society for Clinical Data Management (SCDM)

Eligibility Requirements: Applicants must meet one of the four following criteria sets:

• Holds a bachelor’s degree or higher and has a minimum of two years of full-time clinical data management experience
• Holds an associate’s degree and has a minimum of three years of full-time clinical data management experience
• Has four or more years of full-time clinical data management experience
• Has part-time work experience that equals or surpasses the full-time experience requirement

Applicants must submit an application as well as a CV.

Exam Details: The exam seeks to establish a universal standard of education, experience, and knowledge by which certified individuals would be recognized in the profession of clinical data management.

• Exam Format: 130 multiple-choice questions that assess competence and expertise in the field of clinical data management
• Exam Duration: Maximum of 3.5 hours
• Exam Delivery: Online, computer-based exams at testing centers
• Exam Fees: Exam fees range from $125 to $325 depending on membership and country of origin. There is a reduced fee for retaking the test within one year
• Exam Dates: Exams are scheduled through Prolydian and are proctored virtually, so there is no need to travel to a testing site.

Renewal Process: Renewal fees range from $60 to $150 depending on membership and country of origin. Certification is valid for three years. CCDMs must obtain 18 continuing education units (CEUs) within three years, 60 percent of which must be directly related to clinical data management training.

Career Enhancement for CCDMs: Clinical data management professionals can enhance their career through certification by validating a specific skill set and knowledge that certifies them as experts in their field and shows the ability to mentor and prepare others for certification as a CDM.

Certification can benefit organizations because by hiring CCDMs, the company ensures best practices, efficiency, improved quality, comprehensive knowledge, excellence in the field, and a commitment of employees to professional development.

Learn More About Clinical Research Certification

Clinical research professionals wishing to learn more about clinical research certification can take a free online course offered by The National Institutes of Health . Topics covered by the course include:

• Roles and responsibilities of the investigator and the institution
• Regulatory issues
• Ethical issues involved in human subjects research
• Clinical investigators and the mass media

This course is offered 24 hours a day online and offers an exam at the end. Attendees who gain a score of 75 percent or higher on the exam will receive a certificate that verifies that the participant has gained an overview of the information presented in the course.

With her passion for uncovering the latest innovations and trends, Kimmy Gustafson has provided valuable insights and has interviewed experts to provide readers with the latest information in the rapidly evolving field of medical technology since 2019. Kimmy has been a freelance writer for more than a decade, writing hundreds of articles on a wide variety of topics such as startups, nonprofits, healthcare, kiteboarding, the outdoors, and higher education. She is passionate about seeing the world and has traveled to over 27 countries. She holds a bachelor’s degree in journalism from the University of Oregon. When not working she can be found outdoors, parenting, kiteboarding, or cooking.

Related Articles

• Upskilling in the Allied Health Professions
• Single-use Plastics in Medicine Raise Concerns About Sustainability
• How to Become a Clinical Research Associate

Related Programs

A Career Path Guideline : How to Become a Clinical Research Associate (CRA)

If you want to become a clinical research associate (CRA), you need to begin by first ensuring if this career path is appropriate for you. Are you really interested to be a part of clinical research industry? Can you come across completion in ensuring clinical trials are conducted ethically and safely ? Are you keen in a career that allows you to grow up and take on more responsibilities? If so, then a career as a clinical research associate may be sound suitable for you!

Following is outlined what you will require to succeed in a career as a CRA (clinical research associate). You will also find good information about CRA as a career, such as job duties, job description (JD), a list of prospective employers, salary prospects and much more!

Job Description (JD) Clinical Research Associate

A CRA has an important task within the clinical trial process. He/she has the key responsibility to verify that the safety, rights and well-being of human subjects (patients) are protected and that the reported clinical trial data are accurate, verifiable from source documents and complete. Most importantly, the clinical research associate makes sure that the conduct of the trial is in compliance with the recently approved protocol or amendment(s) protocol, with good clinical practice (GCP), and with applicable regulatory authority requirement. The CRA performs clinical site (hospital) monitoring and manages/ collects clinical research documents, including clinical study protocol, ICFs (Patient Informed Consent Form), CRFs (clinical case report forms), IBs (Investigator Brochure) and clinical trial related documents.

Clinical Research Associate Job Responsibilities

CRA need to ensure safe and right conduct of clinical trials according to ICH-GCP guidelines.

• Maintain current understanding of organization’s SOP (standard operating procedures) and also required sponsor SOPs if applicable.
• CRA required in providing clinical study progress reports to Clinical Trial Manager /Designee periodically.
• CRA must plan & conduct pre-study site evaluation visit with Sr. Clinical Research Associate / Clinical Trial Monitor.
• CRA must conduct clinical site feasibility and also help CTMs in study feasibility.
• CRA Prepare and maintain Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents etc.
• CRA prepare EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation.
• CRA also attend and assist with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
• CRA plan & perform SIV (site initiation visit) with Sr. Clinical Research Associate/CTM
• At the time of site initiation visit (SIV) CRA meet clinical investigators (PI) and their team to make sure that all aspects of the study are understood by the principal investigator and his/her staff, validate the suitability of the EC / IRB & make sure that all records required for the study are complete.
• CRA is also expected to handle clinical central laboratory in regard to issues of site.
• CRA plans, conducts site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee.
• CRA keep track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development.
• Assessment of subjects (patients) for study protocol compliance though SDV (source data verification).
• CRA monitor patient Informed Consent progression for clinical study.
• CRA examine on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
• CRA make out the discrepancies in the case report forms against the source documents, resolve them and after that take away the CRFs.
• Periodic follow up with clinical site for resolution of DCFs or any queries.
• Adverse event/serious adverse event AE/SAE reporting and follow up with the concern departments.
• CRA make sure appropriate Investigational Product (IP) answerability at site.
• CRA plan and conduct site close out visit (SCV) and make sure that collection of all clinical study data are complete.
• CRA prepare the applicable site visit reports and follow up letter.
• Subsequent to study completion, make sure that investigational products (IP) of the study are returned to the CRO / sponsor.

Education and Training Required to Become a Clinical Research Associate (CRA)

To get an entry-level job in clinical research, you are required to be an undergraduate degree in life sciences, nursing, biotech or medical sciences and a diploma or certification in clinical research from a reputed institute. It is suggested to have a graduate degree as it can enable one to stand eligible for much more senior level positions, a higher pay grades and achieve benefits over other individuals.

It is sometimes feasible to break into this profession from the administrative side as well without having formal education and learning in the above-mentioned areas; however it demands a significant amount of administrative knowledge in clinical research, and perhaps further qualifications.

Skills Required to Become a Clinical Research Associate (CRA)

In order to turn out to be an efficient clinical research associate, you need to have a certain set of skills. Being efficient in this skill set could allow you to move into more responsibilities and better pay. These skills include:

• Understanding of the clinical research, healthcare system, healthcare regulation and procedures for regulating the growth of healthcare products.
• Should be capable to prepare a clinical development plan.
• Should be capable to make sure clinical trial data is reliable and correct and that the legal rights, sincerity and privacy of trial subjects are safeguarded.
• Require to have a complete knowing of liabilities and responsibilities of performing study with human subjects.
• Should have a knowing of the challenges and restrictions of implementing and retaining databases.

Who Employs Clinical Research Associates (CRA)?

• Clinical research associates (CRA) are generally employed by the following kinds of organizations:
• Contract Research Organization (CRO)
• Biotech companies
• Pharmaceutical companies
• Self-employment (Freelance basis)

Clinical Research Associate (CRA) Salary

The salary ranges of clinical research associates can differ based upon a variety of aspects, which include their level of education and learning, their amount of experience, the place of work, whether they have done any clinical research diploma/ training/ certification or not, the stage of funding for their project, organization HR policy and several others.

The fact is that there is no unique salary data for clinical research associates in many countries such as Canada or the United States, India. We can on the other hand, get an excellent idea of their salary level by looking at the CRA job posting posted by various organization in their website, pay scale grading organization and many reputed job portals.

Career Growth for Clinical Research Associates (CRA)

Despite the fact that career structures vary from organization to organization, you can usually go up from an entry-level position in clinical research such as Jr. research associate, clinical trial administrator pretty quickly, based upon aspects such as the expertise of your skill set, your level of commitment, your prior experience, your level of training & education, and several others. Increased responsibilities may possibly include tasks such as:

• Doing the job on pre-trial procedures.
• Participating investigator meetings (IM).
• Coordinating with ethics committee (EC).
• Coordinating with regulatory authority.
• Monitoring and training Jr. staff.
• Project management.

James Lind Institute offers multiple self paced online training programs that can help you become a Clinical Research Associate. To know more about the training programs available please click here http://www.jliedu.com/programs

Related posts:

Profile cancel

Email Not published

• Mission and Introduction

Since incorporation in 1991, SOCRA has been through many changes, all of which were important contributors to our growth. The path that brought us to this level started with an exploration into available educational opportunities for site based clinical coordinators. The lack thereof and the thirst for information resulted in an organization founded by creative and forward thinking leaders. Today, the organization has realized membership growth and program expansion exceeding its expectations.

The most important factors in our success over the past years have been our membership support, our educational programming and our certification program . Innovation and investment of skill and knowledge have resulted in an exceptional organization with expertise and understanding in providing educational programming and member services.  The quality of our programs and educators is unparalleled.

Our educational programming has been wonderfully successful as has our certification program and our noteworthy Annual Conference . We are committed to devoting a tremendous effort to developing and providing new and innovative approaches to learning. We intend to explore new educational opportunities and to maximize those opportunities for future success.

• Welcome from the President
• List of Directors
• 2024 Board of Directors Election
• Nominations

In order to promote quality clinical research, to protect the welfare of research participants, and improve global health, SOCRA's mission is:

• To establish educational programming and provide continuing education for clinical research professionals
• To establish an internationally recognized certification program for clinical research professionals (CCRP®)
• To foster the professional development and peer recognition of clinical research professionals

That all clinical research fully protects every research participant and is accomplished with excellence, quality, and professionalism.

ACRP Certification

With a 30-year legacy, acrp certification is the most reputable credentialing program in clinical research. since 1992, more than 40,000 professionals and their employers have come to trust acrp certification as the mark of excellence in clinical research., “joining acrp and becoming certified was the best thing i ever did to jumpstart my career in research and has opened many doors for me.”, jeri burr, ms, rn, ped-bc, ccra, facrp acrp certified since 1999, benefits of certification >, start your next career journey by exploring acrp’s flagship certification and subspecialty credential programs below. each program provides specific information and resources on exam eligibility, exam content, how to apply, scheduling & testing, how to prepare, and after your test. if you have questions, explore the faq page or the acrp certification handbook ., acrp certified professional, acrp-cp ® is a credential formally recognizing clinical research professionals of all types, regardless of their roles or functional activities on the clinical study team., learn more >, certified clinical research associate, ccra ® is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., certified clinical research coordinator, ccrc ® is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., certified principal investigator, cpi ® is a credential formally recognizing clinical research professionals with experience as a principal investigator or sub investigator on multiple studies., acrp medical device professional, acrp-mdp ® is a credential formally recognizing clinical research professionals with specialized knowledge in medical device clinical trials. candidates must be acrp certified to sit for this exam., acrp project manager, acrp-pm ® is a credential formally recognizing clinical research professionals with specialized knowledge in project management. candidates must be acrp certified to sit for this exam., the academy’s acrp-cp, ccrc, ccra, and cpi programs are accredited by the  national commission for certifying agencies (ncca),  which sets internationally recognized standards for the development and operation of certification programs. the standards assure that a program is valid, reflects current practice, and treats candidates fairly and are based on the established processes for developing certification exams., the most respected certification thought leaders in the country agree that ncca accreditation is the gold standard when it comes to accreditation of programs that certify professionals working in healthcare—including the clinical research industry. when you’re searching for certification programs, make sure you always look for the ncca-accredited program seal., bring certification to your team —acrp certification is an ideal solution for managers looking to enhance team knowledge, grow leaders, and signify to others that their study teams are among the best of the best. learn more >.

Explore Jobs

• Jobs Near Me
• Remote Jobs
• Full Time Jobs
• Part Time Jobs
• Entry Level Jobs
• Work From Home Jobs

Find Specific Jobs

• $15 Per Hour Jobs
• $20 Per Hour Jobs
• Hiring Immediately Jobs
• High School Jobs
• H1b Visa Jobs

Explore Careers

• Business And Financial
• Architecture And Engineering
• Computer And Mathematical

Explore Professions

• What They Do
• Certifications
• Demographics

Best Companies

• Health Care
• Fortune 500

Explore Companies

• CEO And Executies
• Resume Builder
• Career Advice
• Explore Majors
• Questions And Answers
• Interview Questions

Clinical Research Associate Education Requirements

The educational requirements for a clinical research associate are a bachelor's degree in a relevant field, such as biology, nursing, psychology, business, or pharmacy. The job requires project management skills, which can be obtained through certifications like Certified Clinical Research Professional or Certified clinical research associate.

What education do you need to become a clinical research associate?

What degree do you need to be a clinical research associate.

The most common degree for clinical research associates is bachelor's degree, with 65% of clinical research associates earning that degree. The second and third most common degree levels are master's degree degree at 17% and master's degree degree at 7%.

• Bachelor's , 65%
• Master's , 17%
• Associate , 7%
• Doctorate , 6%
• Other Degrees , 5%

What should I major in to become a clinical research associate?

The best majors for a clinical research associate include biology, nursing, psychology, business, pharmacy, medicine, health care administration, biochemistry, biophysics, molecular biology, public health, and chemistry. According to the education requirements, a bachelor's degree is the most common entry point for this career.

• Biology , 23%
• Nursing , 14%
• Psychology , 10%
• Business , 8%
• Other Majors , 45%

Most common colleges for clinical research associates

Clinical research associates often get their degrees at University of California, Santa Barbara, University of North Carolina at Chapel Hill, and University of California - Davis. Here are the most common colleges for clinical research associates in the US based on their resumes.

Best majors for clinical research associates

Best colleges for clinical research associates.

Advanced education for clinical research associates leads to higher salaries and better job opportunities. Zippia identified the best colleges for clinical research associates based on metrics like admissions rate, retention rate, mean earnings of graduates, and student working ratios. The University of Pennsylvania, University of Michigan - Ann Arbor, and Georgetown University are among the top schools for aspiring clinical research associates. These colleges offer a strong educational foundation for those pursuing a career in this field.

1. University of Pennsylvania

Philadelphia, PA • Private

In-State Tuition

2. University of Michigan - Ann Arbor

Ann Arbor, MI • Private

3. Georgetown University

Washington, DC • Private

4. Johns Hopkins University

Baltimore, MD • Private

5. Columbia University in the City of New York

New York, NY • Private

6. Vanderbilt University

Nashville, TN • Private

7. University of Florida

Gainesville, FL • Private

8. California State University - Bakersfield

Bakersfield, CA • Private

9. University of Southern California

Los Angeles, CA • Private

10. Northeastern University

Boston, MA • Private

20 best online courses for clinical research associates

1. Understanding Clinical Research: Behind the Statistics

If you’ve ever skipped over the results section of a medical paper because terms like “confidence interval” or “p-value” go over your head, then you’re in the right place. You may be a clinical practitioner reading research articles to keep up-to-date with developments in your field or a medical student wondering how to approach your own research. Greater confidence in understanding statistical analysis and the results can benefit both working professionals and those undertaking research...

2. Clinical Trials Operations

This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will...

3. Good Clinical Practice ICH GCP for Clinical Research

Certification on ICH GCP E6 R2 Good Clinical Practice for Clinical Research The Only Complete Course You Can Find Online...

4. Certificate Course in Clinical Research (CCCR)

A Clinical Research Course-ICH-GCP E6(R2), Clinical Trials, Essential Documents, Sponsor, Investigator, Pharmaceuticals...

5. Clinical Trials Analysis, Monitoring, and Presentation

In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data...

6. Clinical Trials Data Management and Quality Assurance

In this course, you’ll learn to collect and care for the data gathered during your trial and how to prevent mistakes and errors through quality assurance practices. Clinical trials generate an enormous amount of data, so you and your team must plan carefully by choosing the right collection instruments, systems, and measures to protect the integrity of your trial data. You’ll learn how to assemble, clean, and de-identify your datasets. Finally, you’ll learn to find and correct deficiencies...

7. Good Clinical Practice for Clinical Research Professionals

The Complete, Certified ICH GCP (R2 & R3) Course for Investigators, Study Coordinators, Sponsors, Monitors and Study staff...

8. The Beginners Course for Clinical Research

The Essentials of Clinical Trials - Clinical Research for Beginners...

9. Drug Development

The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New...

10. Design and Conduct of Clinical Trials

In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, a trial without...

11. The Simplest Guide to Clinical Trials Data Analysis with SAS

Step into the world of Pharmaceutical industry Clinical Trials Clinical Research Biostatistics Clinical SAS SAS...

12. Basic of Clinical Data Management

Clinical Data Management...

13. Making Data Science Work for Clinical Reporting

This course is aimed to demonstate how principles and methods from data science can be applied in clinical reporting. By the end of the course, learners will understand what requirements there are in reporting clinical trials, and how they impact on how data science is used. The learner will see how they can work efficiently and effectively while still ensuring that they meet the needed standards...

14. Clinical Data Science

Are you interested in how to use data generated by doctors, nurses, and the healthcare system to improve the care of future patients? If so, you may be a future clinical data scientist!\n\nThis specialization provides learners with hands on experience in use of electronic health records and informatics tools to perform clinical data science. This series of six courses is designed to augment learner’s existing skills in statistics and programming to provide examples of specific challenges,...

15. Clinical Research for beginners

The Art of Publishing - Master Pub Med, Study design, Biostatistics, Journal choice, Manuscript writing & Referencing...

16. Good Clinical Practice (GCP)

Key features of the GCP guideline, roles and responsibilities involved and the requirements of essential documentation...

17. Predictive Modeling and Transforming Clinical Practice

This course teaches you the fundamentals of transforming clinical practice using predictive models. This course examines specific challenges and methods of clinical implementation, that clinical data scientists must be aware of when developing their predictive models...

18. Certificate Course in Drug Regulatory Affairs (DRA)

Pharma course (NDA, ANDA, CTD, DMF, USFDA, Regulatory strategy, GMP, Clinical Research, Orange Book, Pharmaceuticals)...

19. Constructing a Website With Google Sites

For Teachers and Students...

20. Pharmaceutical Industry Drug Regulatory Affairs (DRA)

Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs...

Top 10 most affordable universities for clinical research associates

The most affordable schools for clinical research associates are University of Florida, hunter college of the city university of new york, and california state university - bakersfield.

If the best universities for clinical research associates are out of your price range, check out these affordable schools. After factoring in in-state tuition and fees, the average cost of attendance, admissions rate, average net price, and mean earnings after six years, we found that these are the most affordable schools for clinical research associates.

1. University of Florida

Cost of Attendance

2. Hunter College of the City University of New York

3. california state university - bakersfield.

4. SUNY Farmingdale

Farmingdale, NY • Private

5. University of South Florida

Tampa, FL • Private

6. California State University - Fresno

Fresno, CA • Private

7. Brigham Young University

Provo, UT • Private

8. Florida International University

Miami, FL • Private

9. Minot State University

Minot, ND • Private

10. Florida State University

Tallahassee, FL • Private

Top 10 hardest universities to get into for clinical research associates

The hardest universities for clinical research associates to get into are University of Pennsylvania, Johns Hopkins University, and Vanderbilt University.

Some great schools for clinical research associates are hard to get into, but they also set your career up for greater success. The list below shows the most challenging universities to get into for clinical research associates based on an institution's admissions rates, average SAT scores accepted, median ACT scores accepted, and mean earnings of students six years after admission.

Admissions Rate

SAT Average

2. Johns Hopkins University

3. vanderbilt university, 4. columbia university in the city of new york, 5. georgetown university.

6. Stanford University

Stanford, CA • Private

7. Northeastern University

8. Northwestern University

Evanston, IL • Private

10. New York University

Top 10 easy-to-apply-to universities for clinical research associates.

The easiest schools for clinical research associates to get into are AdventHealth University, barry university, and d'youville college.

Some schools are much easier to get into. If you want to start your career as a clinical research associate without much hassle, check out the list of schools where you will be accepted in no time. We compiled admissions rates, average SAT scores, average ACT scores, and average salary of students six years after graduation to uncover which were the easiest schools to get into for clinical research associates.

1. AdventHealth University

Orlando, FL • Private

2. Barry University

3. D'Youville College

Buffalo, NY • Private

4. Gwynedd Mercy University

Gwynedd Valley, PA • Private

5. Mount Saint Mary's University

6. Curry College

Milton, MA • Private

7. Nyack College

8. Felician University

Lodi, NJ • Private

9. Wayland Baptist University

Plainview, TX • Private

10. Notre Dame College

Cleveland, OH • Private

Average clinical research associate salary by education level

Clinical research associates with a Doctorate degree earn more than those without, at $82,012 annually. With a Master's degree, clinical research associates earn a median annual income of $76,978 compared to $69,127 for clinical research associates with an Bachelor's degree.

Clinical Research Associate Education FAQs

What is the best college for clinical research associates, search for clinical research associate jobs.

Updated April 5, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

• Clinical Associate Education Requirements
• Clinical Coordinator Education Requirements
• Clinical Project Manager Education Requirements
• Clinical Research Assistant Education Requirements
• Clinical Research Coordinator Education Requirements
• Clinical Research Manager Education Requirements
• Clinical Trial Coordinator Education Requirements
• Clinical Trial Manager Education Requirements
• Coordinator And Research Assistant Education Requirements
• Laboratory Manager Education Requirements
• Research Administrator Education Requirements
• Research Associate Education Requirements
• Research Coordinator Education Requirements
• Research Nurse Education Requirements
• Research Project Coordinator Education Requirements
• Clinical Associate
• Clinical Coordinator
• Clinical Project Manager
• Clinical Research Assistant
• Clinical Research Coordinator
• Clinical Research Manager
• Clinical Trial Coordinator
• Clinical Trial Manager
• Coordinator And Research Assistant
• Laboratory Manager
• Research Administrator
• Research Associate
• Research Coordinator
• Research Nurse
• Research Project Coordinator
• Clinical Research Associate Athens, GA
• Clinical Research Associate Belleville, IL
• Clinical Research Associate Byram, MS
• Clinical Research Associate Centereach, NY
• Clinical Research Associate Chili, NY
• Clinical Research Associate Chula Vista, CA
• Clinical Research Associate Glendale, AZ
• Clinical Research Associate La Habra, CA
• Clinical Research Associate Massapequa Park, NY
• Clinical Research Associate Missoula, MT
• Clinical Research Associate Nampa, ID
• Clinical Research Associate Oklahoma City, OK
• Clinical Research Associate Raleigh, NC
• Clinical Research Associate Saint Petersburg, FL
• Clinical Research Associate Tumwater, WA
• Zippia Careers
• Executive Management Industry
• Clinical Research Associate
• Clinical Research Associate Education

Browse executive management jobs

Providing courses, products & services so Clinical Research Professionals can thrive & achieve fulfilling careers.

How to Get into Clinical Research

by ClinEssentials Team | Feb 7, 2024 | Clinical Research Careers , Clinical Research Coordinators , Clinical Trial Assistants , Tips for Research Professionals | 0 comments

Clinical Research is an exciting, rapidly growing field, but figuring out what you want to do and how to find a job can be challenging! 

If you want to break into the Clinical Research industry, it is helpful to learn the fundamentals and where you can get beneficial experience that will lead you to the best role for you.

This article goes over what Clinical Research is, what it takes to secure a job in the Clinical Research industry, and how to find the right job based on your skills and experience.

What is Clinical Research?

The primary goal of Clinical Research is to develop new ways to prevent, detect, diagnose, and treat diseases and other medical conditions. 

According to the National Institutes of Health (NIH), “Clinical Research is vital to the NIH mission of enhancing health, lengthening life, and reducing the burdens of illness and disability.”

A team of Clinical Research Professionals works on each clinical trial. Each research team member has a specific role, and the overall goals are to prioritize patient safety, maintain compliance, adhere to the study protocol, and provide quality data on time and within budget.

Clinical Research is rewarding work because of its potential to make advancements in preventing, treating, curing, and improving quality of life. 

How can I get a job in Clinical Research?

The education and experience credentials needed to become a Clinical Research Professional vary based on the specific role. 

A Clinical Research Coordinator (CRC), for example, can be an entry-level position. A high school diploma or GED is required for the CRC role, and zero to two years of Clinical Research experience is ideal. A college degree is not a requirement; however, a four-year bachelor’s degree in a health-related field may be helpful for CRCs who want to continue to level up in the industry. Being familiar with medical terminology is also a plus.

The role of a Clinical Research Associate (CRA) is a very sought-after job but is not entry-level. Most CRAs have a 4-year Bachelor of Science degree in a health-related field. Experience as a CRC or CTA will help prepare you to be a CRA. Individuals typically move into the CRA role after 1-2 years of monitoring or other relevant experience. 

An advanced degree in Clinical Research, biological sciences, or a related field can help you distinguish yourself from other applicants. 

Employment in Clinical Research is highly competitive. However, if you are open to starting at an entry-level position, you can gain experience through your work, take advantage of training courses, and use this to apply for job openings. Pursuing specific courses and certifications also helps you gain opportunities and a helpful advantage.

What are the different types of roles in the Clinical Research industry?

It is important to note that there are many different roles in the Clinical Research industry. It is helpful to understand how each role fits into the overall picture.

For this article, we focus on three of the most well-known and desired roles in Clinical Research: Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), and Clinical Trial Manager (CTM). We encourage you to research other positions outside of these three as well to see which role best resonates with your ultimate career goals. We also recommend choosing your area of interest based on your skill set, educational background, and experience. 

Clinical Research Coordinators 

CRCs typically work on-site and are under the supervision of the Principal Investigator (PI). CRCs support, facilitate, and organize daily clinical trial activities for one or more trials at their research site. They work directly with patients.

Typical daily responsibilities of a CRC include:

• Assist with patient recruitment
• Conduct study procedures as outlined in the protocol
• Follow up on action items
• Collect vitals, ECGs, and patient labs
• Communicate with team members and/or study participants
• Provide updates to the PI and CRA
• And much more!

Experienced CRCs who excel in the role can advance to the CRA role. Additional training will be required when advancing from the CRC to the CRA role. 

Clinical Research Associates 

CRAs, also called Study Monitors, are typically employed by a Sponsor, aka Pharmaceutical company or Clinical Research Organization (CRO). Some CRAs are also independent contractors.

CRAs manage clinical trials to ensure the safety of new medications, devices, or procedures. A CRA’s primary responsibility is to monitor the progress of an ongoing clinical trial and verify compliance with the trial study protocol and ensure patient safety. Most CRAs manage multiple clinical trials simultaneously.

Typical monitoring responsibilities for a CRA include:

• Asses Serious Adverse Events (SAEs), Adverse Events (AEs), and Adverse Events of Special Interest (AESIs)
• Verify patient eligibility
• Follow up on and create new action items
• Review study documents
• Communicate with the site staff and answer questions
• Confirm the integrity of the data
• Provide training for site personnel
• Write monitoring visit reports

CRAs generally travel to assigned sites for monitoring approximately eight to ten days per month. Most CRAs work out of a home office when they are not traveling. 

You can read about the similarities and differences between CRCs and CRAs here . 

Similar to CRCs being promoted to CRAs, the next progression for a CRA is to the Clinical Trial Manager role.

Clinical Trial Managers 

A CTM is a challenging role that comes with a lot of responsibility. As leaders of a Clinical Research Team, CTMs are accountable for the success of their studies. Different from other Clinical Research roles, CTMs are involved in each stage of a clinical study – from Study Start-Up to Study Close-Out. A Clinical Trial Manager typically oversees day-to-day clinical activities and drives study timelines. 

Typical responsibilities for a CTM are:

• Review monitoring visit reports
• Develop recruitment and retention methods
• Train and manage the Clinical Research Associates
• Communicate relevant information and issues to the Sponsor
• Ensure the trial runs smoothly
• Manage study vendors
• Analyze and approve invoices

Clinical Trial Managers are in meetings for at least half of their workday, have limited travel, and generally complete most of their work from their home office. This blog post offers a comprehensive look at the CTM role.

The next level for a CTM is becoming a Project Manager (PM) or Associate Director of Clinical Operations.  

Where can I find training opportunities for research professionals?

Companies may offer training opportunities, but you can also find more comprehensive training and certification courses outside of your company.

Here are a few organizations to check out and see if the training they offer is right for you:

• Association of Clinical Research Professionals (ACRP)
• Society of Clinical Research Associates (SOCRA)
• Aspiring CRA
• The CRA Academy
• The CRA Helper

*Please note: This is not an exhaustive list. Instead, it gives you a few websites to check. A simple Google search will result in additional options.

The ClinEssentials CTM Training Course

The ClinEssentials CTM Training Course is for aspiring and current Clinical Trial Managers who feel underprepared, overwhelmed, or intrigued about the CTM role. 

The All Access + LIVE Course is for individuals with at least 1-2 years of Clinical Research experience. Participants receive over 12 hours of direct access to the instructor and learn via live training sessions that include practical application of concepts learned and self-paced learning modules.

The Self-Paced Course is for more experienced individuals with at least four years of Clinical Research experience. Self-paced participants can learn at their own pace, as their schedule allows, and can join the live Q&A Sessions to have the instructor answer questions and learn from others.

Click here to learn more about and register for CTM Training and receive the education, skills, resources, and support to help you become a leader in your field!

How can I find relevant experience for a job in Clinical Research?

Internships are offered at most clinical research companies.

Look for internship opportunities at Pharmaceutical companies or CROs. Many provide internships to undergraduates interested in pursuing a career in Clinical Research. This is a great way to get in the door, work your way up, and take advantage of the available opportunities for gaining experience.

Volunteer or work in a hospital

Consider volunteering at a local hospital or medical center. Working directly with patients and other healthcare workers in a medical setting provides a valuable experience that is a helpful addition to your resume.

Networking with people currently employed in Clinical Research is a great way to learn and understand what it takes to have a successful career. This also may lead to connections for job leads and opportunities. 

Along with joining local networking groups, consider becoming active in an online community. Ask questions, add comments, and show your interest. 

Take it further by following industry leaders like Dan Sfera and Tiffany Ashton on LinkedIn. Read their posts (don’t forget to read the comments!), watch their videos, and you will learn valuable information that may give you an edge in your career.

If you are already working in Clinical Research and want to move to the next level, share your intentions with your boss. Ask for opportunities to take on additional responsibilities to help you learn and gain experience in the role.

For example, if you are a CRC who wants to become a CRA, ask if you can shadow the CRA during their next monitoring visit. Or, if you are a CRA who wants to become a CTM, ask if you can plan a Kick-Off Meeting, provide training for other CRAs, or take on another CTM task. 

You can talk about your experience and demonstrate that you showed initiative in your interviews, which is a great way to stand out from other candidates.

Next steps for aspiring Clinical Research Professionals

Clinical Research is a gratifying career. Take time to develop some skills needed to succeed in the industry. 

ClinEssentials created the Introduction to Clinical Research Guidebook for anyone who is new to or interested in pursuing a career in the Clinical Research industry. The Guide features fundamental facts, a 10-step plan to start your career journey, trusted websites, free resources, and more. 

Click here to purchase the Guidebook – and jump-start your career with the information you need to know.

Read the guide, research, do your “homework,” and look for ways to get experience to be prepared with a well-planned and effective strategy to land your dream job. Also, be sure to write an effective and focused resume that helps you stand out. 

PRO TIP: Be careful of resume writing services that are not familiar with the Clinical Research industry. They may offer good suggestions, but not necessarily suggestions that will help you stand out in the Clinical Research job market.

You can Book a Call with a Clinical Research Career Expert from ClinEssentials who knows what employers are looking for. You’ll start with the basics and conclude with actionable steps to keep you moving forward. Click here to schedule a 60-m inute cal l – and receive four fantastic freebies to use as you continue on your career path.

Tiffany Ashton, MAS, CCRA, has over twenty years of experience as a Clinical Research Professional. Tiffany is the Director of Operations for ClinEssentials, a consultant in the Clinical Trial Manager role, and the expert instructor for the CTM Training Course.

Submit a Comment Cancel reply

Your email address will not be published. Required fields are marked *

Submit Comment

More Resources

How Clinical Trial Managers Are Involved with Study Recruitment

by ClinEssentials Team | Jan 10, 2024 | Clinical Research Careers , Clinical Trial Managers , Tips for Research Professionals

CRA Responsibilities for Each Stage of a Clinical Trial

by ClinEssentials Team | Dec 27, 2023 | Clinical Research Careers , Clinical Research Associates , Tips for Research Professionals

How to Review a Clinical Trial Protocol (Free Checklist Included)

by ClinEssentials Team | Nov 8, 2023 | Clinical Research Careers , Clinical Trial Managers , Tips for Research Professionals , Tools for Research Professionals

What is the Difference Between a CRC and a CRA?

by ClinEssentials Team | Oct 4, 2023 | Clinical Research Careers , Clinical Research Associates , Clinical Research Coordinators , New to Clinical Research , Tips for Research Professionals

Guest Column | November 24, 2020

Starting a career in clinical research: 7 things we wish we knew.

By Laurie Halloran and Michelle Pratt, Halloran Consulting Group, Inc.

This experience has shaped my passion for clinical research education at all levels and my vow to pay it forward. I try to consistently work on initiatives that bring better learning opportunities and more defined competencies and standards to clinical research roles. – Laurie Halloran

In recent years, careers in clinical research have become more plentiful and the opportunities for formal clinical research education are more accessible. The industry, however, is still looking at a talent shortage that could become acute in the next decade. 1 A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry. The real challenge clinical research professionals face at every stage on their career paths is the need to be two things: technically astute (e.g., regulatory knowledge, medical/pathophysiology expertise, data science, technology solution navigation) and emotionally intelligent. These two components of clinical research professionals are pivotal to the success at every level. The intent of this three-part series is to provide insight and guidance to help professional clinical researchers effectively navigate their careers.

Entry-Level Clinical Research Positions And Potential Career Paths

A clinical research coordinator (CRC) 2 works under the direction of a principal investigator (PI) at a clinical site to coordinate and facilitate the daily clinical research activities, including screening and recruiting patients, collecting and recording data, and maintaining study documentation. Working at the site provides a different perspective of clinical research than a CRA or clinical trial associate (CTA) role. Progression on the site side of clinical research typically starts with more senior CRC roles, CRC manager, and, depending on the size of the research site, even leading an entire research department. Many CRCs also move to the industry side of clinical research into a CTA or CRA role.

CTA is a position that supports management of clinical trials under the direction of the clinical trial manager (CTM). In this role, a CTA gains exposure to many aspects of trial management, including working directly with study plans and timelines, vendor oversight, patient enrollment, regulatory documentation, and oversight of the trial master file (TMF) (all study documentation). Many CTAs advance their career though more senior CTA roles, CRA roles, and eventually as CTM or clinical project manager (CPM).

A CRA 3 is the most commonly available clinical research position. In this role, a CRA acts as a liaison between the clinical trial management and the clinical sites that are enrolling subjects. The main responsibilities are clinical monitoring, overseeing the progress of the clinical trial at the site and ensuring that it is being conducted appropriately. The daily focus is on protocol and regulatory compliance, data reliability, and the proper care, treatment, and safety of patients. Many CRA positions can be found at contract research organizations (CROs); however, some sponsor companies also have typical CRA roles or an in-house CRA position. In terms of career development, a CRA typically progresses up through more senior CRA roles to team lead, CRA manager, or potentially to CPM.

Any of these positions is a great way to get into clinical research. Each of these positions provides an education on all elements of clinical research and a foundation for future roles and growth in the industry. By getting this broad view, you will be able to learn more about the specific aspects of clinical research that interest you so you can tailor your career path 4 in that direction. In addition, try to identify an area that continues to challenge you and helps you grow.

If you are interested in exploring different options, we suggest visiting the ACRP’s Find Your Element campaign. 5

Advice From Former Entry-Level Candidates

While the behaviors and skills expected for an entry-level position in clinical research are similar to those that would be expected of any professional candidate, the importance of patient safety, the volatility of the industry, and the number of technical skills you must develop in a short period of time are challenges unique to the life sciences space. For those who have not had any formal training in clinical research, here are seven insights that would have been helpful at the beginning of our careers.

1. Patient Safety Drives All the Work You Do

Clinical research has strict regulations worldwide that have been inspired by key historical events (e.g., Tuskegee syphilis experiments, Jesse Gelsinger’s death). 6,7,8 Change has often come following tragedy or public outcry. Understanding the historical context helps you understand why clinical research is differentiated from other experimentation. Also, it is important to understand that whether or not you are working directly with patients, you can impact patient safety.

2. Understand the “Whys”

You can work in this industry for a long time and never be directly involved in drug or device development. Review the drug discovery and development process 9 to understand the different phases of development and associated regulations. Figure out where your position fits into this process and why it is important. Become familiar with the roles of the different departments in your company and why you need to interact with them. Understanding the bigger picture, emphasizing the reason why every responsibility you have, regardless of career level, is meaningful and important to help you understand why the clinical trial you are working on is being done.

3. Learn your GxPs

Good practice quality guidelines 10 ensure that your drug or device is safe and functions as expected. Having at least a high-level understanding of these guidelines will help you approach your work with a quality mindset and support a culture of quality at your company.

4. If It Is Not Documented, It Didn’t Happen

Everything in clinical research must be documented, and document control is not optional. All companies should have standardized processes for the preparation, recording, and correction of data as well as the maintenance of the records throughout the life cycle of a document. Be organized in your document filing and don’t put your TMF filing and maintenance on the back burner.

5. You Will Have Many Questions

In this industry, you will never have all the answers, regardless of how experienced you are. Questions not only help you but help study team members or sites who “don’t know what they don’t know.” Question things that do not make sense operationally (e.g., ask if a procedure is really necessary when developing a protocol), always considering the patients, the big picture, and your objectives.

6. Communication Skills Are Key 11

With so many moving parts in clinical research, having effective communication habits is necessary. Educational programs do not necessarily set you up with the soft skills 12 that you need when entering the workforce. Become familiar with the concept of soft skills and when you join a company, take the time to understand their communication best practices.

7. You Are the Driver of Your Career

Larger companies in the industry may have a developed training program; however, at many smaller companies you will be learning on the job. Be as proactive as you can to create a network and a system of support (e.g., a coach or mentor). Volunteer for opportunities outside of your comfort zone, mentor others, and learn as much as you can. Advocate for yourself and try not to compare yourself to others, as there are so many different needed skillsets in this industry. Find a path that feels like the right fit, based on your strengths and passions.

As an individual contributor in clinical research, your speed, high-quality results and deliverables, proactivity in keeping management informed, and attention to detail are all equal. Different skills, abilities, and insights will be needed depending on if you would like to continue in a contributing role or move toward management and leadership. In our next installment of this series, we will discuss the transition from an individual contributor to a management role.

References:

• https://www.pharmavoice.com/article/2016-11-talent-war/
• https://forteresearch.com/news/roles-and-responsibilities-of-a-clinical-research-coordinator/
• https://clinicalresearchfastrack.com/clinical-research-associate-career/
• https://tracs.unc.edu/index.php/services/education/careers
• https://careersinclinicalresearch.org/
• https://blog.lillytrialguide.com/clinical-trial-history-regulations-regulatory-guidelines-requirements/
• http://cdn2.hubspot.net/hub/149400/file-410979295-pdf/docs/CRT_Timeline_download.pdf
• https://clinicalcenter.nih.gov/recruit/ethics.html
• https://www.nebiolab.com/drug-discovery-and-development-process/
• https://www.ich.org/page/quality-guidelines
• https://www.indeed.com/career-advice/resumes-cover-letters/communication-skills
• https://www.indeed.com/career-advice/resumes-cover-letters/soft-skills

About The Authors:

Like what you are reading?

Sign up for our free newsletter, newsletter signup.

Get extra -20% OFF THE ALL-IN-ONE COURSE with "EXTRA20"

SAVE UP TO -50%

ON YOUR FIRST PURCHASE

Clinical Research Associate – Enterprise

• Level: Professional
• Continuing Education Units: 80 contact hours, 8.0 CEUs
• Certificates: GCP, VIARES

COURSE Content

• Background of medicines development
• Research and discovery stage & product development
• Clinical development
• Regulatory submission, Health Technology Assessment, lifecycle management
• ICH GCP and other applicable regulations
• Applicable international and national regulations
• ICH GCP E6 (R2)
• FDA Regulation
• Quality Assurance: Audits and Inspections
• Elements of a Study Protocol according to ICH GCP
• Trial Design
• Methodologies
• Ethics Committees
• Sponsor / Monitor
• Investigator
• Competent Authority
• Assessing Investigational Sites
• Training and Upgrading Investigational Sites
• Organizing the Initiation Visit
• Setting up the required documentation – Essential Documents
• Planning, Conducting, Documenting, and Reporting Monitoring Visits
• Managing Issues
• Organizing the Close-Out Visit
• Documentation
• Patient Information
• Collecting Patient Consent
• Special Patient Populations
• Types of Adverse Events
• Identifying and Reporting Serious Adverse Events
• Definition of investigational medicinal product (IMP) / study drug
• Provision of the IMP
• Drug Accountability
• Randomization, blinding and un-blinding processes
• Managing Expiry Dates
• Collecting IMP after Site Close-out
• Clinical Research Form (CRFs)
• Process of Data Collection
• Data Collection Systems
• Data validation process
• Query Process
• Data Quality Assurance

VIARES CERTIFICATE

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:

• course title
• contact hours
• continuing education units (CEU)
• your overall course score
• date of completion
• personal certificate verification code

We also show you how to best share your certificate on LinkedIn and other social media platforms.

There are several reasons why you might consider getting a CRA certification:

Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.

Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.

Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.

Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.

Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.

Hear from our graduates

The VIARES Talent Program is an opportunity for achieving more in-depth knowledge regarding the Clinical Trials, but it is also suitable for those who are looking for a career change and thus, new to the Clinical Trials Field. Extensive live training

with professionals was provided throughout the program, knowledge checks, and assignments which were later discussed during the sessions. I strongly recommend the VIARES Talent Program and its team.

It was a very interactive course! I liked it! The topics were very enriching and very organized. The moderators were very knowledgeable. I loved the assignments; they made me think harder! I was also privileged to get the one year membership

with ACRP and I also completed the ELKA which was very enjoyable. Thanks to the VIARES team.

reviews curated by judge.me

Why become a CRA?

There are several reasons why you might consider becoming a Clinical Research Associate (CRA):

Opportunity to contribute to developing new drugs and medical devices: As a CRA, you will be involved in clinical trials that test the safety and effectiveness of new drugs and medical devices. This is an opportunity to contribute to the development of new treatments that can improve the lives of patients.

Career growth potential: Clinical research is a growing field, and there is a high demand for experienced CRAs. With experience, you can advance to positions with greater responsibility and higher pay.

The salary of a CRA can vary depending on several factors, including the location, type of employer, level of experience, and educational background.

According to the data from the U.S. Bureau of Labor Statistics, the median annual salary for clinical research associates was $70,720 as of May 2020. However, salaries can range from around $47,000 to over $125,000 per year.

Overall, a career as a CRA can be financially rewarding, with opportunities for career advancement and increased earning potential over time.

Flexibility: CRAs can work for pharmaceutical companies, contract research organizations, academic institutions, or government agencies. There are also opportunities to work remotely or travel to different clinical trial sites.

Personal fulfillment: As a CRA, you will be part of a team that is working to improve patient outcomes. This can be personally fulfilling and rewarding work.

Ultimately, whether or not you should become a CRA depends on your interests, skills, and career goals. If you are passionate about medical research, enjoy working in a team environment, and have strong attention to detail, a career as a CRA may be a good fit for you.

WHAT ARE TYPICAL RESPONSIBILITIES OF A CRA?

The typical responsibilities of a CRA can vary depending on the employer, the stage of the clinical trial, and the size of the study team. However, some common responsibilities of a CRA may include:

• Study site management: CRAs are often responsible for managing the study sites participating in a clinical trial. This may involve conducting site feasibility assessments, training site staff on study protocols and procedures, and monitoring site performance.
• Data collection and review: CRAs may collect and review study data to ensure that it is accurate and complete. This may involve reviewing medical records, lab reports, and other documentation.
• Adverse event monitoring: CRAs are responsible for monitoring adverse events reported by study participants and ensuring that they are reported and managed appropriately.
• Regulatory compliance: CRAs must ensure that the study is conducted in accordance with relevant regulations and guidelines, such as good clinical practice (GCP) and the International Conference on Harmonisation (ICH) guidelines.
• Documentation: CRAs must maintain accurate and complete study documentation, including case report forms (CRFs), study logs, and other study-related documents.
• Communication: CRAs must communicate effectively with study team members, site staff, and study participants to ensure that the study is conducted smoothly and that any issues are addressed in a timely manner.
• Subject recruitment: CRAs may be involved in supporting recruitment of eligible study participants.

Overall, the role of a CRA is multifaceted and requires a high level of attention to detail, organization, and communication skills.

Is this the best option for me?

To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.

In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.

If you are not sure if this is the right training for you,  we are happy to help you make the right decision.  Email us at [email protected] and we will contact you.

€  239,90

• Language - English
• Access on desktop, tablet and mobile
• Online Exam & Certificate of Completion
• Contact Hours and CEUs

Other Enterprise Courses

€  359,90

• Professional
• 12-16 weeks online and self-paced

• 4-6 weeks online and self-paced

Get new job posts and all the news about our VIARES clinical research courses in your inbox!

• All Courses
• Verify Certificate
• Privacy Policy
• Term Of Service
• VIARES Trainer
• Contract Sales Specialist

Our support and sales team is available 24 /7 to answer your queries.

Clinical Research Training courses all prices incl. VAT

Copyright © 2023. All rights reserved.

Request Course outline

Explore our pricing plans, 12 payments.

• One year access to your training courses
• Personalized certificate upon completion
• VIARES exam – 2 attempts included
• All online-training course material
• Online access to our learning management system
• One year access to your training courses​
• VIARES exam – 2 attempts included​
• Including the VIAES CAREER ACCELERATOR
• Plan ends automatically after 12 payments
• No training course handouts for offline learning
• No unlimited access
• All benefits from the montly payment plan
• Life-time access to your purchased course
• Training course handouts included
• Life-time support from the VIARES tutors
• And much more...