clinical research associate usc

Armstrong Research

Dr. april armstrong.

Dr. April Armstrong is Associate Dean of Clinical Research at Keck School of Medicine at USC. She also serves as Director of Clinical Research for the Southern California Clinical and Translational Research Institute (SC CTSI). In the Department of Dermatology at USC, she serves as Vice Chair, Director of Clinical Trials and Outcomes Research, and Director of the Psoriasis Program.

Dr. Armstrong obtained her medical degree from Harvard Medical School and completed dermatology residency at the Harvard Dermatology Residency Program. She also obtained a Master of Public Health degree from Harvard School of Public Health. Prior to joining faculty at the University of Southern California, Dr. Armstrong served as Vice Chair, Director of Clinical Research, and Director of Psoriasis Program at dermatology departments at the University of California Davis and later at the University of Colorado.

For her research focus, Dr. Armstrong is particularly interested in the appropriate use of systemic agents, comparative effectiveness research, technology-enabled healthcare delivery, and comorbidities associated with inflammatory skin diseases. Dr. Armstrong has conducted studies examining how new therapies impact patients’ disease states, quality of life, and their access to medical care. She is also examining how technology-enabled healthcare delivery can be applied to manage patients with chronic dermatological diseases. She is a federally funded investigator with an extensive clinical trial experience, having led or collaborated on over 120 studies. She has authored over 300 peer-reviewed scientific publications and has been an editor for the top pharmacology textbook Principles of Pharmacology. Her work has been supported by the NIH, Patient-Centered Outcomes Research Institute (PCORI), the Agency for Healthcare Research and Quality (AHRQ), the Dermatology Foundation, and the National Psoriasis Foundation.

Dr. Armstrong has held multiple leadership positions at professional societies, serving as a Medical Board of the National Psoriasis Foundation, Councilor to the International Psoriasis Council, Steering Committee Member for Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. Dr. Armstrong is Chair for Teledermatology SIG at the American Telemedicine Association. She also has served on multiple task forces and committees at the American Academy of Dermatology. Dr. Armstrong also has also served on the editorial boards of JAMA Dermatology, Journal of the American Academy of Dermatology, and Telemedicine and eHealth. She was also past President of Sacramento Valley Dermatologic Society.

“ I am fortunate to work with talented students, young doctors, and research staff every day. Some take the blind faith and travel across the country or the globe to work with me in Los Angeles. Over the years, I have found that I learn from them just as much as the other way around. Their courage, grit, and compassion fill me with the optimism that the future of dermatology is bright. Importantly, our lives become intertwined in the most beautiful and meaningful ways. I am privileged to be a witness to their incredible journeys. ” –April Armstrong, MD MPH

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USC Norris Comprehensive Cancer Center

An NCI-designated Comprehensive Cancer Center

Anthony B. El-Khoueiry, MD

Associate Director, Clinical Research  [email protected]

Anthony El-Khoueiry, MD, is the Associate Director for Clinical Research at USC Norris and an Associate Professor of Clinical Medicine at the Keck School of Medicine of USC. Dr. El-Khoueiry completed his medical degree, residency in internal medicine and fellowship in hematology and oncology at USC. He has extensive experience in clinical and translational research through his roles as medical director of the Clinical Investigations Support Office and director of the phase I program at the USC Norris. He is the recipient of the National Cancer Institute Cancer Investigator Team Leadership Award in 2011.

Dr. El-Khoueiry has established an international reputation in the treatment of gastrointestinal cancer and in particularly in research related to hepatobiliary (liver, gall bladder and bile duct) and pancreatic cancers. He is a member of the National Cancer Institute Hepatobiliary Cancers Task Force and chair of the Southwest Oncology Group hepatobiliary cancers subcommittee. He has lead several multicenter trials in HCC such as the phase II study of guadecitabine, a novel hypomethylating agent, and a phase I/II study of the anti-PD-1 antibody Nivolumab (checkmate 040) in patients with advanced hepatocellular carcinoma which was published in Lancet and resulted in accelerated approval by the FDA. He also served on the steering committee of international studies such as the randomized phase 3 study of cabozantinib versus placebo in patients with HCC who failed or are intolerant of sorafenib and which culminated in the approval of cabozantinib for advanced HCC. He is currently the lead investigator on an international phase Ib study combining pembrolizumab and regorefanib in advanced hepatocellular carcinoma. His other research interest includes drug development as manifested through his leadership of several first-in-human trials of various novel anti-cancer therapies, including ones that were developed at USC such as PRI 724, a novel Wnt pathway inhibitor, and sEphB4-HSA, an inhibitor of the EphB4-Ephrin B2 interaction with immunomodulatory properties. Lastly, as a member of the Stand up 2 Cancer Epigenetics Dream Team and the USC PI for this collaborative grant, he dedicates part of his time to the evaluation of epigenetics drugs in various solid tumors.

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Human Research Protection Program

• Starting a Research Trial: the Basics

System Access

All USC faculty, staff and students are assigned a  USC NetID  account, also known as Shibboleth or enterprise account. This is essential to access systems in the university (email, iStar IRB submission system).

Some USC schools and departments maintain additional local systems such as Health Science Campus’s Medmail. Contact your departmental administrator to determine exactly which accounts you will need to activate.

iStar Registration

iStar is the online system used to submit research protocols for review and approval by the IRB.  iStar registration is required prior to submitting a protocol. To register an account in iStar go to istar.usc.edu . Protocols are reviewed for compliance with regulations of human subjects research (IRB), animal research, radiation safety and biosafety. The human subjects submission forms of iStar are used both at USC and CHLA.  IRB approval is required before recruitment can begin.  

Training and Certification

Investigators and staff who engage in research are required to complete courses specific to their responsibilities in research. The following links provide instructions for registration and training certifications. Additional training may be required by certain offices or sponsors. CITI course information and access .

• Required CITI Courses
• Research Training Finder  
• Department of Contracts and Grants Trainings

Study sponsors may require and provide additional training.

At USC, research trials are managed in two different workflows depending on whether the funding source is industry (corporate sponsorship) or non-industry (federal monies, foundations, or grants). New trials should be directed to either the CTO or DCG (see below),  according to the funding source. An MCA (Medicare Coverage Analysis) is required for most industry and non-industry trials, which means that while DCG will handle the contract, the CTO will need to complete the MCA.

Clinical Trials Office (CTO)

CTO provides  Medicare Coverage Analyses (MCA) , budgeting, contracting and sponsor relations for industry funded clinical trials. CTO also provides MCA for non-industry clinical trials. All industry sponsored trials (and non-industry sponsored trials that will incur healthcare professional fees and/or facilities billing) must be submitted to the Clinical Trials Office.

OnCore – Clinical Trial Management System

OnCore is a web-based Clinical Trial Management System (CTMS) used by CTO for managing industry sponsored clinical trials. All industry sponsored trials (and non-industry sponsored trials that will incur healthcare professional fees and/or facilities billing) must be submitted into OnCore.

• OnCore Training and Support Information:   [email protected]
• OnCore Training Resources
• OnCore Login

Department of Contracts and Grants (DCG)

With the exception of industry sponsored clinical trials, all contract and grant proposals at USC must be submitted to the USC DCG , after proposal and budget preparation by the investigators’ school(s). The CTO conducts Medicare Coverage Analyses (MCA) for non-industry as well as industry trials.

Cayuse Sponsored Projects (SP)

Cayuse Sponsored Projects (SP) is USC’s system for proposal and award management.

Sponsored Projects Accounting

Sponsored Projects Accounting (SPA) manages the post-award financial management of non-industry clinical trials. This includes working closely with study teams, school administration and DCG on tasks such as account establishment, letter of credit drawdowns, invoicing, collection, payment application, expense transfers, financial reporting (if applicable), and generally helping ensure appropriate management of sponsored funds.

Research trials at USC require IRB approval as well as approval from specific research committees depending on the materials and methods of the trial.

Need Guidance on Starting a Clinical Study at USC?

The study navigation tool will help you determine where to go to activate your clinical research study at USC, including contracting offices, review committees, and ancillary services. Based on your answers to basic questions (type of funding, study location), it displays the primary units and systems you can expect to interact with on the road to study activation. Note: there may be exceptions, depending on your specific circumstances.

• Clinical Trial Workflow

The Institutional Review Board (IRB) is a committee charged with reviewing, approving and monitoring research projects involving human subjects for compliance with institutional policies and state, local, and federal laws. The committee includes faculty, staff and members of the community. The IRB reviews clinical research as well as social-behavioral research. The IRB also serves the function of HIPAA Privacy Board.

• How to Get IRB Review

Ancillary Regulatory Committees

Certain research activities require additional regulatory committee reviews and approvals (in addition to IRB oversight):

• Radiation Safety Committee
• Institutional Biosafety Committee
• Clinical Investigations Committee
• Stem Cell Research Oversight Committee
• Institutional Animal Care and Use Committee
• Conflict of Interest Review Committee

Southern California Clinical and Translational Science Institute (SC CTSI)

The  SC CTSI  is a research institute of the University of Southern California (USC) and Children’s Hospital Los Angeles (CHLA). The SC CTSI provides help with biostatistics, clinical research informatics, training and education, community engagement, team building, and funding for projects.

The SC-CTSI Clinical Research Support offices at USC and CHLA assist with research navigation, budgeting and contracting, study coordination, participant recruitment, and regulatory advice. The Clinical Trials Unit (CTU) supports complex, high-risk clinical trials and provides ad hoc services such as blood sample acquisition and processing.

SC CTSI activities include:

• Research Tools and Services
• Training grants
• Clinical studies directory
• sc-ctsi.org.    (323) 442-2872

Clinical Investigator Support Office (CISO)

The Clinical Investigational Support Office (CISO ) is the clinical research infrastructure of Norris Comprehensive Cancer Center. CISO personnel assist investigators with the conduct of all oncology trials for which USC is a Lead Academic Participation Site, including oncology trials at LAC+USC Medical Center and Children’s Hospital of Los Angeles (CHLA). As one of the original eight NCI-designated Comprehensive Cancer Centers, USC Norris’s Clinical Investigational Support Office has been managing clinical trials for over 20 years. All Norris studies are required by the National Cancer Institute (NCI) to be overseen by CISO. Studies that include cancer patients as a sub-population and not the main focus/objective of the research may not be required to be submitted to CISO. Contact CISO to discuss how this requirement applies to any specific study.

[email protected] (323) 865‐0451

Human Research Protection Program (HRPP) 

The HRPP operates under the direction of the Vice President of Research and Innovation. The HRPP is responsible for establishing the IRB policies for USC as well as identifying and implementing best practices to ensure continued USC accreditation. Additional responsibilities include oversight of USC IRBs as well as providing education to the human subjects research community.

Request Virtual Office Hours

[email protected]

Office of Research and Innovation

The  Office of Research and Innovation  is responsible for all aspects of research administration, research ethics and research advancement for the university. The office invests in research initiatives, encourages sponsored-research, and provides resources to promote high ethical standards in research.

 [email protected] (213) 740-6709

Office of the Chief Information Officer 

The  Office of the CIO oversees data protection. The office mission is to offer direction and support for the effective application and integration of information technology to improve the teaching, learning, research, and administrative environment of the university.

Gus Anagnos Chief Information Security Officer Office of the Chief Information Officer [email protected] (213) 740-7197

• USC Laboratories and Services

There are over 60 research laboratories and services located at the University of Southern California main campus (UPC), Health Science Campus (HSC), and Children’s Hospital Los Angeles (CHLA). Laboratory services include hematology, radiology, materials imaging, flow cytometry, histology and pathology, spectroscopy, cell culture and analysis.

• Point of Care Testing Information
• Keck School of Medicine USC/Pathology
• Laboratory Agreement and Utilization Worksheet (Lab Research Agreement Form) Oct 2021
• Laboratory License and Related Documents Request Form (May 2021)
• Department of Radiology

Research at Los Angeles General Medical Center

USC and Los Angeles General Medical Center have established an agreement for the conduct of clinical research including billing and approvals for research services conducted at Los Angeles General Medical Center. For more information, visit Research at LAC

Investigational Drug Services (IDS) for Drugs & Biologics

Research involving any investigational drugs or biologics is the responsibility of the USC IDS Pharmacy. Investigational drug or biologics receipt, accountability, storage, compounding, dispensing and disposition are managed in compliance with the FDA, industry sponsors, State and Federal Regulations. This responsibility applies to research conducted at any of these facilities:

• Keck Hospital of USC
• USC Norris Cancer Hospital
• Clinical Trials Unit at Norris
• Outpatient clinics
• Los Angeles General Medical Center
• Maternal Child and Adolescent Research

[email protected] (323) 865-3538

Investigational Device Services:

Prior to being used in a study, devices for research must be cleared for safety and hazard potential by Keck and Norris Hospitals purchasing departments. A purchase order must be obtained, even if the sponsor is providing the item free of charge. In order to comply with State and Federal regulations and accreditation requirements, no piece of equipment, device or supply may be brought directly into the hospital. Everything must be received through hospital materials management. All vendor representatives must be registered and must sign in daily through Reptrax. Any person who is not an employee or faculty of Keck or Norris Hospital must obtain permission to be on premises. This is accomplished by contacting:

Hospital Medical Staff Office (323)442-8686

Persons entering the OR and/or contacting/observing a patient must have proof of negative TB test. From October 1 through March 31, persons contacting/observing a patient must provide evidence of flu vaccination. There are no exceptions to these health clearance requirements.

Complete the Research Associate Questionnaire to pursue research associate credentialing for Keck Medical Center of USC.

• Research Associate Questionnaire

Supplies and materials:

Lilia Stanfill Manager, Materials Management [email protected] (323) 865-9980

Hospital operations and logistics:

Ellen Whalen, RN, DRSc Associate Hospital Administrator [email protected] (323) 442-8396

The Food and Drug Administration regulates all drugs, biologics and devices whether used for investigational purposes or seeking approval for marketing.

To conduct a clinical investigation of a drug, biologic, or device, FDA must approve the research. For an investigational new drug an IND application is required. For an investigational device an IDE application is required. The FDA may determine the research is exempt from the IND or IDE requirement.

In most cases, the clinical trial sponsor files the IND(Investigational New Drug Application) or IDE(Investigational Device Exemption). If an investigator holds an IND or IDE the investigator assumes the responsibilities of both an  investigator and a sponsor .

• NIH Research Toolkit
• NIH Regulatory Binder Checklist

Investigational Drugs and Biologics

An Investigational New Drug (IND) application is the document submitted to the FDA for permission to conduct a clinical study using a drug or biologic that is new or being used for an unapproved dosage, formulation or indication. If a study does not require an IND, the investigator must provide the IRB with an FDA determination of IND exemption.

Investigational Devices

An Investigational Device Exemption (IDE) application must be submitted to FDA to allow for the conduct of a clinical study using a significant risk device that is new or not approved for a given use (A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject).

If the investigation involves the use of a device that does not pose significant risk to humans (a non-significant risk device), an IDE application to FDA is not required. Submissions for non-significant risk devices are made directly to the IRB. The sponsor-investigator must explain to the IRB why the device does not pose a significant risk.

If compensation will be provided to study participants, in lieu of cash, it must be made in the form of a ClinCard (debit card) for recurring payments, or a single payment Prepaid One-Time Card. Request for both cards may be processed via USC eMarket request forms.

ClinCard Services

For assistance with the ClinCard program or general questions: (213) 740‑6015 [email protected]

USC utilizes on-line systems for most research administration processes, in addition to OnCore:

Total Access for Research Administration (TARA)

TARA is the portal linking to research administration systems at USC. With the exceptions noted below, TARA does not support research conducted at Children’s Hospital of Los Angeles (CHLA).

Conflict of Interest

diSClose is a system for USC Employees to disclose any possible  conflicts of interest . Any outside financial relationships with pharmaceutical or device companies must be disclosed in diSClose regardless of whether research is involved. Researchers who are proposing or have received support from the US Deptartment of Health and Human Services (including NIH, CDC, HRSA, and AHRQ) must also make an annual disclosure of all financial interests related to their institutional responsibilities to USC, regardless of whether any of these interests give rise to a conflict of interest related to their research.

A regulatory binder is a set of records maintained for each clinical trial. The documents include all submissions and communications with the IRB and other ancillary committees, investigator brochure, and protocol. The following documents are commonly required in the study binder:

• Responsibilities of Sponsor-investigators

USC IRB Membership Rosters

The lists of members on the USC Institutional Review Boards are periodically updated and posted on the following sites.

• Biomedical IRB
• Social Behavioral IRB

Federalwide Assurances (FWAs)

The University of Southern California maintains assurances of compliance, called Federalwide Assurances (FWAs), with the Office for Human Research Protections (OHRP) in the US Department of Health and Human Services (HHS). The University is required to enter into this agreement because it receives federal funding for research involving human subjects. It is an assurance that USC follows a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research.

Certificates for Required Training

Copies of the certifications obtained for all required training should be filed in the regulator binder for the study.

GCP Compliance Statement

• USC GCP Compliance Statement

21 CFR Part 11 Compliance Statement

The following documents ensure that the USC’s iStar system and the Keck Medical Center electronic medical records system are compliant with FDA Part 11.

• iStar system (8/27/13)
• iStar electronic signature (8/27/13)
• EMR Part 11 Keck Medical Center (3/31/16)

USC Emergency Management and Business Continuity Plan

The emergency management and business continuity plan support USC’s central mission of teaching, research, and service by preparing schools and departments to resume critical operations rapidly following a disaster. The university maintains backup and recovery plans to protect against the loss of vital data due to an adverse event or disaster. The following links are provided to USC Emergency Management, Business Continuity and IT Disaster Recovery policies:

• USC Policy Emergency Management
• USC Norris Comprehensive Cancer Center Business Continuity and Disaster Recovery Plan

Clinical Trials Must Be Registered to ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research studies. Registration of clinical research studies is required by law prior to study enrollment. Protocol Registration System (PRS) is the  Clinicaltrials.gov  system used to register and update studies.

HHS has expanded the legal requirements for registering and submitting results for clinical trials involving FDA-regulated drug, biological and device products. National Institutes of Health has issued a  complimentary policy  for all NIH-funded clinical trials including phase 1 studies and clinical trials of behavioral interventions.

Health outcome studies must be registered in clinicaltrials.gov before enrolling subjects This requirement applies to:

• All NIH-funded  clinical trials of behavioral interventions or non-FDA-regulated products.
• Clinical trials involving FDA-regulated drug, biologic and device products
• Any study intended for publication in a journal complying with the ICMJE (International Committee of Medical Journal Editors) or other publication that requires registration to clinicaltrials.gov

Registration of Non-Cancer Trials Jean B. Chan, Associate Director Dept of Contracts & Grants [email protected] (323) 442-2825

Registration of USC Cancer Trials Vicky Soto, Project Specialist Cancer Center- Clinical Investigator Support Office [email protected] (323) 409-4359

How to Register With Clinicaltrials.gov

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• Privacy, Confidentiality, and Anonymity in Human Subjects Research
• Urgent Review

Serving patients, researchers and sponsors by expediting clinical trials for novel and promising therapies

Meet the CTO

By rocio maldonado.

The Clinical Trials Office is here to help. Meet the people who are working to assist you in opening your clinical trial at USC. Our mission is to work with departments with efficiency, transparency and excellent customer service.

Melissa Archer, J.D., Director , joined the Clinical Trials Office in February 2016. She has specialized in industry sponsored research for the past 6 years of her career and previously served as a Principal Contract Officer at Cedars-Sinai Medical Center. Prior to that, she spent the majority of her career as a medical malpractice and hospital litigation attorney in the Tampa Bay Area. She is a native Floridian and a graduate of the University of Florida and Stetson University College of Law.

Chris Ancheta, Project Specialist, joined the Clinical Trials Office in April 2016. He came to us from UCLA, where he worked as a Research Administrator in the cancer center; focusing on Medicare coverage analysis, budget development/negotiation with industry sponsors, NIH-NCI grants management and post-award for Oncology and HIV/infectious disease clinical trials. Chris will be working closely with Melissa, Director of the CTO, to establish and improve the CTMS workflow, and develop applicable policy and procedures. He is responsible for the triage of study submissions and task management in OnCore.

Amanda Ruelas, Medicare Coverage Analyst,  joined the Clinical Trials Office in March 2016.  She has been part of the USC family since 2011, where she worked as a Clinical Data Specialist and transitioned into the role of Clinical Research Coordinator. Her 4 years as a Clinical Research Coordinator has allotted her extensive knowledge and understanding of clinical trials and research. She graduated with her Bachelor of Science in Cellular & Molecular Biology from California State University Dominguez Hills and is an active member of the Society of Clinical Research Associates.

Pre-Award: Team A

Denise Deack, Budget Specialist, develops and negotiates industry-sponsored budgets primarily for the Division of Oncology. She has worked for USC for over 25 years in various capacities and therapeutic areas within the Clinical Trials Office.

Sara Katrdzhyan, Senior Contract Manager, is responsible for negotiating contract terms for clinical trial agreements. Sara has successfully executed contracts for clinical trials and has built great working relationships with clinical research staff and principal investigators. She has extensive experience in managing and maintaining compliance of agreements. Prior to joining USC, Sara was a Contract Compliance Manager, where she oversaw a group of compliance specialists at Healthways in Phoenix, AZ. She also worked for several years at the Jet Propulsion Laboratory in Pasadena, CA.

Pre-Award: Team B

Rocio Maldonado, Sr. Contracts Officer, is responsible for managing and negotiating clinical trial contract terms. She joined CTO in February 2015. Prior to joining USC, she had negotiated purchasing agreements and was managing all business operations for Perioperative Services.

Teresa Trejo, Budget Specialist, is responsible for developing and acting as a University representative in budget negotiations for industry-sponsored clinical trial budgets. She has been with USC for 14 years where she has gained extensive knowledge in negotiating and developing budgets for clinical trials. She has successfully built great working relationships with sponsoring companies and clinical research staff.

Pre-Award: Team C

Bobby Gatson, Budget Specialist, has worked with industry clinical trials since 2007. He has worked in the capacity of a Contract Analyst and Budget Specialist. Prior to 2007, Bobby had been a research coordinator and Q/A Q/C coordinator with NIH and CDC-funded, infectious disease studies.

Adena Gharaptyan, Contracts Officer, is responsible for managing and negotiating clinical trial contract terms. She has also worked in the capacity of Budget Specialist at CTO. Previously, she had negotiated purchasing agreements with LA County Internal Services Department. Adena has been part of the USC family since 2012, where she graduated with her Bachelor of Science in Accounting.

Post-Award: Billing

Cindy Morales, Claim Analyst, is responsible for reviewing and processing medical claims. Her role requires that she interpret clinical trial budgets in order to process medical claims accordingly. She was originally part of Sponsored Projects Accounting (SPA) department, and prior to that was a member of the USC CRO team. Cindy’s career at USC, began with the Department of Surgery as an Accounting Representative, primarily focused around medical billing and coding and payment collection. Her current role has further developed her knowledge of research and clinical trials.

Talena Sanchez, Data Entry Operator, administers the TRUE database and email/fax inbox. She coordinates with research teams to review and validate all participant information that is entered in TRUE, as well as maintaining records/logs for the medical claims process. She has held positions with USC’s Health Research Association and Keck Medicine of USC’s Access Center, where she has gained experience in medical billing and clinical trials.

Nora Turrey, Supervisor – Claims Analysis & TRUE , reviews and assesses the scope of clinical research billing for Keck, Norris, LA County and USC CARE providers. She maintains the TRUE database and review of TRUE documents. She has over 20 years of medical services experience within USC.

Post-Award: Accounting

Stephanie Gonzales, Accountant I, manages the clinical trial accounts for post-award. She facilitates the accounts receivable for all studies. Her role involves daily communication with departments and sponsors. Stephanie holds a Bachelor of Science in Accounting and has been working for the University of Southern California for 3 years.

Kyoko McCarthy, Accountant I , is part of the CTO post-award team. She manages the financial aspect of clinical trials and facilitates the receipt of study funds. She has more than 2 years of experience in research funds.

Esther Suko, Accounting Supervisor, oversees the accounting and financial aspects of post-award for clinical trials. Her extensive experience has allowed her to specialize in translating budget details into effective management systems. She has successfully applied her organizational as well as accounting knowledge and skills to develop processes to manage the post-award financial functions of clinical trial operations.

Anna Tan, Accountant I, has been with the Clinical Trials Office for the past two years. In her role, she provides a variety of accounting and financial activities associated with sponsor payments, hospital claims, and study drugs for clinical patient care.

Clinical Research Town Hall Meeting

Oncore training dates.

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Areas Of Work Select Administrative Operations Auxiliary Services Faculty Human Resources Information Technology Keck Medicine of USC

Employment Type Select Faculty Full Time Faculty Part Time Staff Full Time Staff Part Time

Let’s change the world together!

USC is a leading private research university located in Los Angeles – a global center for arts, technology and international business. As one of the city’s largest private employers, responsible for more than $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic schools and units. As a USC employee, you will enjoy excellent benefits and perks , and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work. Think you’ve got what it takes to join us? We invite you to search our open positions and apply!

Postdoctoral Scholar-Research Associate

A postdoctoral position is available at the Section of Biostatistics within the USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California. USC ATRI is an academic institute committed to advancing the development of new treatments for Alzheimer’s Disease (AD), and manages an exciting portfolio of national and international observational studies as well as phase 2 and phase 3 clinical trials in AD. The ATRI Biostatistics Section is looking to expand its statistical team in San Diego.

This position will involve both methodological and applied research in the design, conduct, and analysis of randomized clinical trials with a focus on clinical trials in Alzheimer’s and other neurodegenerative diseases. This individual will split their time working on (a) challenging methodological problems in AD studies, including the modeling and analysis of participant recruitment and retention in multicenter clinical trials as well as predicting disease course and treatment response and (b) gaining experience as a collaborative biostatistician, including conducting power analyses and writing statistical analysis sections for grants and conducting analyses for ongoing studies.

This position offers a hybrid work arrangement, which includes a combination of onsite and remote work.

Location: San Diego, CA

The annual base salary range for this position is $70,000.00 - $90,000.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

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Key searches, about our research programs.

The Catherine and Joseph Aresty Department of Urology is ranked #2 in research funding from the National Institute of Health (NIH) and has ranked in the top 2 over the past two years. “Alongside our clinical excellence, reflected by ‘Top 10’ rankings in U.S. News & World Report (2018-202), this NIH recognition for research excellence attests to the all-around stature of our team,” said Inderbir Gill, MD, Chair and Distinguished Professor of Urology, Shirley and Donald Skinner Chair in Urologic Cancer Surgery and associate dean for clinical innovation.

We attribute this research success to USC Urology’s inherently innovative mindset, which is strongly rooted in clinical-translational excellence. Our focus is on advancing the science, thereby improving the outcomes and lives of our patients

“More specifically, this ranking reflects our scientific innovations in epigenetics, robotic simulation, and stem cell & regenerative medicine, as well as our deep collaborations with inspiring colleagues in translational genomics, single cell genomics, drug development for novel therapeutic targets, and engineering & AI.”

The department includes four full-time Ph.D. basic scientists and four medical oncologists who have active laboratory programs focused on various aspects of urologic oncology. Each has a dedicated fully-equipped laboratory with technical staff support. The laboratories are located in either the USC Norris Comprehensive Cancer Center or the adjacent Harlyne J. Norris Research Tower.

In addition to individual laboratory equipment, the USC Norris Comprehensive Cancer Center has 12 laboratory cores with technical staff and equipment available to cancer center laboratories. These include DNA sequencing, genomics, microarrays, cell culture, cell and tissue imaging, small animal imaging, pharmacoanalytical core, transgenic mouse modeling, translational pathology, biostatistics and informatics.

Clinical Research

Innovation, discovery and game-changing urologic patient care are at the forefront of clinical research

In addition to the basic science facilities, the Catherine and Joseph Aresty Department of Urology also maintains three mature clinical databases for oncology patients treated with cystectomy, radical prostatectomy and partial or total nephrectomy at USC since 1981 and is actively developing a similar testis cancer database. Each of these databases has between 1000-4500 patients, and there is full-time trained staff responsible for chart abstracting, follow-up and management of the databases. These databases are IRB-approved, fully searchable and integrated with pathologic tumor banks of available frozen and fixed tissue and blood samples.

Clinical Research Activities

• Inderbir Gill, MD, MCh:   Minimally invasive techniques in management of genitourinary cancers. Needle biopsy of small renal mass: radiologic, histologic and cytogenetic and molecular correlates.
• Sia Daneshmand, MD :  Outcomes in multidisciplinary management of testis cancer and bladder cancer.
• Anne Schuckman, MD:   Outcomes in squamous cell cancer of the penis with tissue correlates.
• Jacek Pinski, MD, PhD:   LHRH receptor polymorphisms and response to androgen-deprivation therapy in prostate cancer patients.
• Mitchell Gross, MD, PhD:   Microtubule-targeted therapy for high-risk localized prostate cancer.

National/International Trials (Partial List)

The GU Oncology team at USC is involved in numerous national and international clinical trials and registries. The following is a partial list of some of the dozens of trials offered.

• SWOG S1011- A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer.
• SWOG S1314- SWOG S1314- A Randomized Phase III Study Of Co-Expression Extrapolation (Coxen) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer- Study Co-Chair
• 4B-13-1 Cysview® Blue Light Cystoscopy Registry
• 4B-13-4 Evaluation of the UroVysion™ Test in Predicting Recurrence and/or Progression of Disease in Patients Receiving initial BCG for Primary High Grade Ta-T1 and CIS Urothelial Carcinoma of the Bladder

Basic Science Research

The department prioritizes and is committed bench to bedside urology research

The department’s basic research activities are directed by Gangning Liang, PhD. All of the faculty members below have indicated their willingness to have urologic oncology fellows in their labs. Past fellows have worked in the laboratories of Drs. Jones, and Pinski, among others.

Intramural Basic Science Research Activities (Partial List)

• Gangning Liang, PhD: Epigenetic Alterations in Pre-malignant Tissue of the Bladder; Determining the mechanistic and therapeutic roles of microRNAs in bladder cancer
• Jacek Pinski, MD, PhD:  (medical oncology):   Comparison of Neuroendocrine (NE) Cell Differentiation of Normal Prostates between Ethnic Groups (DOD PC 051 259)
• Amir Goldkorn, MD (medical oncology): Telomerase as a therapeutic target and as a predictive biomarker in GU malignancies, specifically in tumor sub-populations (cancer stem cells, circulating tumor cells)
• Parkash Gill, MD (medical oncology):   Regulation of angiogenesis in bladder cancer; Eph4B expression in bladder and prostate cancer.
• Mitchell Gross, MD, PhD (medical oncology):   Circulating markers to predict docetaxel-response in CRPC; Proteomic Approach to Understand Therapeutic Response to Cancer Treatments
• Vicky Cortessis, PhD (Environmental, genetic, and molecular epidemiology): etiology of testis cancer and related conditions (cryptorchidism, hypospadias, sub-fertility) and bladder cancer; determinants of recurrence, late effects and resistance of these malignancies to systemic therapy.

Labs & Facilities

Cutting-edge research is performed in state-of-the-art space

The laboratories of urologic cancer research include a 2,300 square foot unit located on the seventh floor of the USC Norris Comprehensive Cancer Center and a 1,400 square foot unit located on the fifth floor of the Norman Topping Tower (adjoining the USC Norris Comprehensive Cancer Center ). The laboratory program focuses on the molecular and cellular biology of human bladder and prostate cancer.

Faculty members in the Catherine and Joseph Aresty Department of Urology who maintain individual laboratories include Roger DeFilippo, MD and Chih-Lin Hsieh, PhD, and Gangning Liang, MD, PhD .

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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 to improve physical or mental health undergoes clinical research trials. During these trials, a drug or a medical device might get approved for consumer or hospital use. 

Clinical research associates (CRA) play a critical role in the health care industry and in improving public health. They liaise between those who sponsor research and those who facilitate clinical research. Even before 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 act as liaisons between the institutions that sponsor and fund the clinical research trials and the clinics that conduct the research. They're in charge of ensuring the clinical trials run smoothly, monitoring all the procedures, processes, and results, and ensuring the researchers follow established guidelines and protocols at every step. 

A clinical research associate works on behalf of the sponsor (pharmaceutical company, university, or health organization) or for a contract research organization (CRO) that 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 following ethics and safety regulations.

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 input 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 the creation of publications

Where you’ll work

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.

Skills needed

Clinical research associates need certain skills to get hired and be successful in their roles. Whether or not you currently possess these skills, you can learn and acquire them through 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 the organization you work for and your experience level. According to Glassdoor, clinical research associates in Canada earn an average salary of $ 73,209 [ 1 ]. The job outlook for clinical research associates is projected to be moderate to good in nearly all provinces and territories in Canada through 2026, according to the Job Bank [ 2 ].

How to become a clinical research associate.

A CRA career can be fulfilling because you are essentially 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. Qualify for certification.

You can take several paths to becoming a certified CRA in Canada. One path is to earn a high school diploma and clock 3,000 to 3,500 part-time hours of work experience in the field. At least one of those years of part-time work must be in Canada and must have been within the past five years. This work is typically in a supporting role, helping experienced CRAs. Your tasks will likely start mundane, but you will get more advanced assignments as you gain experience. 

Another path is to graduate high school and gain two years of qualifying experience—again, typically in a support role—in the last five years. 

The third path is to earn a post-graduate certificate in clinical research and then earn at least one year of Canadian clinical research working experience in the last two years. 

To enrol in a post-graduate certificate program, you will need a bachelor’s degree in health sciences or to be a registered nurse or registered in another regulated health profession. You can also qualify with a certification with a recognized body in health technology or if you’re currently employed in clinical research. 

2. Get certified.

After qualifying, you are eligible to sit for the Certified Clinical Research Professionals Society (CCRPS) CRA certification exam. The CRA course and exam costs USD$450. 

3. Apply for jobs.

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

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 a list of questions to ask your interviewer. 

4. Continue learning.

Earning a master’s degree can help you land a managerial position or salary boost as a CRA. Many types of organizations need clinical research associates, so pursuing higher education can lead to more interesting and dynamic job opportunities. 

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

Glassdoor. " Clinical Research Associate Salaries in Canada , https://www.glassdoor.ca/Salaries/canada-clinical-research-associate-salary-SRCH_IL.0,6_IN3_KO7,34.htm" Accessed April 23, 2024.

Government of Canada Job Bank. " Clinical Research Associate in Canada , https://www.jobbank.gc.ca/marketreport/outlook-occupation/23070/ca." Accessed April 23, 2024.

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