action plan as research coordinator

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Action plan for action research

An Action Research Plan for school including pre, during and final implementation

Related Papers

Flordelez Cailing

ABSTRACT This research is a reading comprehension intervention, a total class of grade I and II pupils in Multigrade class, on the reading comprehension level of ten pupils out of 20 grades I and II pupils at risk for reading failure. They belong to the Frustration Level of their reading comprehension. Pre-test and Post reading was administered to Grade I and II pupils using set of passages from the PHIL-IRI and Developmental Reading Power to determine the reading comprehension skills of each pupils. This study aimed to improve the comprehension skills of grades I and II pupils in Multigrade class. The result showed that ten of the pupils significantly improved in their reading comprehension skills using graphic organizer. All target pupils’ in reading comprehension scores on the standardized PHIL-IRI passages and from the Developmental Reading Power were higher in the post test than at the pre-test. More comprehension gains were found in Phil-IRI passages that did not found in the intervention. Social validity measures taken from the teachers, parents, and pupils revealed positive evaluations of the intervention. Limitations, future direction on research, and applied inferences are discussed.

Joenel Demegillo

This descriptive research study was conducted to determine the relationship of reading comprehension and mathematics performance of the 302 pupils at Anecito Panolino Elementary School of Division of Passi City for the school year 2014-2015. The Phil-IRI test, the profile questionnaire and first periodical grade of pupils in Mathematics were used as the data gathering tool. The statistical tools used were frequencies, means, standard deviation, t-test, one-way Analysis of Variance, and Pearson Product Moment Coefficient of Correlation. Acceptance or rejection of the null hypotheses was based on the.05 alpha level. The pupils of Anecito Panolino Elementary School were males and were in ages six to ten years old. They belong to a family that is earning below the poverty line and were enrolled in Grade V. They have a weak reading comprehension as to speed level, reading level, and comprehension level despite of gender, age, grade level and family income. In gender and family income there is almost a significant difference however in age and grade level it showed almost no significance on reading comprehension. Regardless of groupings, mathematics performance of the pupils was an “unsatisfactory” rating. Significant difference in mathematics performance of the pupils was found on gender however, there is none with respect to age, family income and grade level. The positive correlation between the pupils speed level, reading level, comprehension level and mathematics performance was determined in the study.

Jestoni Jest Pestaño

pilar limin

DepEd Malolos - Region III

Joey R . Cabigao, PhD

This study primarily aims to determine the relationship of teachers’ organizational commitment and instructional competence. Organizational commitment is measured using four dimensions (Celep, 2000) while instructional competence is quantified using DepEd’s Instructional Tool. The study hypothesizes (Ho)that teachers’ organizational commitment and instructional competence have no significant relationship. Descriptive correlational method is utilized with 32 teachers of Malolos City High School-Santisima Trinidad as respondents for SY 2016-2017. Pearson r is employed to identify the degree of relationship at .05 level of significance. Among the four dimensions, the study reveals that only teachers’ Commitment to School (p-value= .020) has a significant relationship with instructional competence. As teachers’ commitment to school becomes stronger, instructional competence goes higher. Other three dimensions have no significant relationships with instructional competence. The study suggests to (1) develop school-initiated program to enhance teachers’ commitment to school leading to higher instructional competence; (2) align school practices with DepEd standards to maximize resources in delivering quality services thus building a good image to school; (3) ensure that institutional vision, mission, and core values are properly articulated to teachers as their guides in the service; and (4) conduct similar studies with larger number of teacher-respondents to determine if the other three aforementioned dimensions have significant relationships with instructional competence. Keywords – organizational commitment; commitment to school; commitment to teaching work; commitment to teaching occupation; commitment to work; instructional competence

edna albaran

This study attempted to enhance the Oral Reading Competence of Grades Four to Six pupil respondents through Remedial Instruction. Specifically, this study sought to answers to the following questions: 1. What is the Oral Reading Competence of Grades Four to Six pupil respondents after conducting two months remedial reading instruction? 2. What is the profile of Grades Four to Six pupil respondents considering the following: sex, attitudes towards oral reading, teacher traits, teaching methodology, exposure to reading materials 3. What is the Oral Reading Competence in English of the Grades Four to Six pupil respondents on the following: pronunciation, vocabulary, grammar, fluency, comprehension and overall results on enhancement oral reading skills after remedial instruction

salvador emproso jr

Kristine Chumacera

THE LEVEL OF ACADEMIC STRESS AND COPING STRATEGIES OF GRADE SIX-BERYL PUPILS AT EM’S SIGNAL VILLAGE ELEMENTARY SCHOOL, S.Y. 2019-2020

Research Action Plan

It is a fact that a research action plan is needed not only to provide a solution for an existing problem but also to provide detailed information for a new study. Research action plans are conducted by numerous individuals and groups on different fields (i.e., business, science, academe, government, technology, etc.).

Research Action Plan Template

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To guide you in creating a research action plan, we have provided some examples (in PDF format) as well as tips on how to create a research action plan.

Action Plan Template

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Action Plan Template to Print

User Research Action Plan Example

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New Research Plan Outline Example

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Research Action Proposal Outline Example

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The Importance of Creating a Research Action Plan

The importance of research action plans cannot be understated. As previously mentioned, they are conducted by various individuals and groups on various fields. Although they are commonly used by business entities and scientific organizations, they are also used by academe (by both professors and students alike), government, technology, sports, and social welfare groups. You may also see quality plan examples & samples .

We will be discussing below the importance of research action plans to each sector that was mentioned.

1. Business

This is where research action plans are constantly created and used. Business entities, specifically companies, conduct research for various reasons. Some do research to develop a new product or improve an existing one, some do research to analyze a new market, some do it for investment analysis , while some companies do it to improve their competitive advantage.

The reasons are not limited to the ones mentioned above, as they are other numerous reasons why companies conduct research. But despite the reason, business research is always aimed toward two things: profitability and sustainability.

Similar to business entities, scientific organizations also do heavy research. Scientific research is always aimed to provide better living conditions for not only humans but all the organisms living on this planet. Additionally, scientific research also centers on discovering things that were not deemed possible before (for example: evolution, relativity, space travel, etc.). You may also like company plan examples & samples .

3. Technology

Science and technology are always intertwined. Technology uses scientific processes to discover new objects and possibilities, while science uses technology to do the same thing. Since the dawn of the digital age, technology has been moving at a breakneck speed. Research has resulted in the most groundbreaking technological discoveries in the 21st century, and more is yet it to come in the next few years. You may also check out advertising plan examples & samples .

The images you see in movies (for example, the Iron Man or Black Panther suit, hologram interaction, nanotechnology) will all be possible sooner than you think.

4. Government

The most advanced and progressive countries rely on their government to do research. Either research to develop new infrastructure, improve transportation and utility systems, eradicate poverty, or to increase foreign and domestic investors, research has been key to improve a country’s economic standing and decrease national debt. You might be interested in sales plan examples .

Similar to science and technology, government and academe are also intertwined in which both sectors benefit each other. In most countries, government asks the assistance of academic institutions to create a research action plan, especially in studies relating to education. You may have also noticed that various educators have taken government positions to extend their expertise to the government. You may also see event plan examples & samples .

Playing sports is both a great pastime and a great money earner. There is money in sports, which is why numerous organizations turn it into a business. Sports-centered research do not only focus on increasing physical abilities and skills but also on marketing. Sports apparel companies like Adidas and Nike, as well as sports personalities like Michael Jordan and Lionel Messi, have all benefited not only from sports health and wellness research but also from sports marketing research. You may also like daily plan examples & samples .

7. Social Welfare

Social welfare is a subcategory of government, but this focuses on human resource specifically the improving of living conditions of individuals and communities.

Social welfare is very important as human resource provides the backbone of every country. If individuals are struggling to meet their daily needs, they become unhealthy and unfocused, thus reducing their effectiveness as being part of the country’s workforce. An unproductive workforce cannot support the government in any way possible. You may also check out management plan examples .

That is why research based on social welfare helps government identify and solve issues in regards to their citizens, aiding them to improve their financial standing to become more effective and efficient in their respective industries.

Market Research Action Plan Example

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Research Plan Proposal Example

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Research Proposal Template Example

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Research Action Plan Outline Example

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Basic Research Action Plan Outline

There is no standard outline in creating a research action plan. But there are sections in which are found in most research action plans. Listed below is a basic research action plan outline which is highly recommended when you will be making your own research plan in the future. You may also see annual plan examples and samples .

Feel free to edit and add sections from the PDF research action plan examples we provided if you think some sections are relevant to your research.

1. Introduction

Sometimes, researchers tend to overlook the introduction as it does not contain the meat of the study. But the introduction is as important as the other sections of the research action plan.

The introduction contains information on why the research is being conducted, and also provides info on how the research will affect the industry or sector it was based on. Remember that the introduction is not a summary of the research . That section is called “abstract.” The abstract is written once the study has been accomplished, and is usually inserted after the introduction.

2. Statement of the Problem

The general statement of the problem identifies the problems or issues that need to be solved in the research. The statement of the problem is usually formulated using WH and H questions, but those questions need to be very specific. Providing general questions will be difficult for the researcher especially when he reaches the data-gathering stage.

Here is an example of a “how” question in a problem statement for a research focusing on hologram smartphone development in 2018:

Incorrect (general): How can smartphone companies develop hologram technology in their products in 2018?

Correct (specific): How can the leading smartphone manufacturers Apple, Samsung, and Vivo implement hologram technology in their high-end phones when they have functions and features lined up for their models in the next two years? You may also like audit plan examples & samples .

Based on the examples above, it will be easier for the researcher to conduct the research as he will be focused on three smartphone companies Apple, Samsung, and Vivo instead of all the smartphone manufacturers as stated in the first problem. Additionally, the second problem centers in on the hologram’s impact to the company’s current portfolio of products, while the first problem does not even recognize the current products of the companies. You may also check out work plan examples & samples .

3. Methodology

The methodology identifies the research’s respondents, locale, research design, and data-gathering procedure. This section basically lists down the methods and procedures the researcher will use in his study. The methodology tremendously aids the researcher as he focuses on the methods and procedures he previously chose, creating a more streamlined study that does not stray away from the problems the researcher wants to solve. You might be interested in weekly plan examples & samples .

4. Analysis of Data

Data analysis is basically the meat of the entire study or research. Data analysis is conducted after all the data have been compiled. There are numerous data analysis methods that researchers use, but the one that is actually used depends on the data that was gathered (number of respondents, type of study, research topic, etc.). You may also see implementation plan examples & samples .

Most of the time, a statistician assists the researcher on tabulating the data and also assists in identifying what analysis method to use. Data analysis will help the researcher determine what recommendations to use, so it is crucial that the data should be analyzed carefully. You may also like job plan examples & samples .

5. Recommendation

Recommendations are the result of data analysis. This section answers the statement of the problem through the data that was gathered and analyzed. Make sure each question in the statement of the problem has a corresponding recommendation. Recommendations are basically the solutions to the problems you presented, so again be specific in how you present your recommendations. You may also check out business plan examples .

Here is an example on a recommendation based on the problem listed above. How can the leading smartphone manufacturers Apple, Samsung, and Vivo implement hologram technology in their high-end phones when they have functions and features lined up for their models in the next two years? You might be interested in transition plan examples & samples .

Incorrect (general): The three smartphone companies should have a separate department to produce a new line of products that will implement hologram technology. (No further analysis is discussed).

Correct (specific): Based on 70% of the responses, the three smartphone companies should have a separate department to produce a new line of products that will implement hologram technology. This will create a more smooth production process as two departments will be working on different products, but still under the same company. (Detailed analysis to follow.) You may also see project plan examples .

6. Conclusion

The research conclusion is the last part of the research and serves a similar purpose to the introduction. The conclusion basically reiterates the information that was previously mentioned in the data analysis and recommendation, but it is not the summary of the entire research. The conclusion also agrees on what recommendations were made by the researcher. No further analysis is conducted in the conclusion. You may also like evaluation plan examples & samples .

Doctoral Thesis Research Plan Example

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Executive Summary for Research Plan Example

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Abstract Research Plan Example

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We hope you found this article to be informative as well as helpful when you will be making your own research action plan. We also included some examples in PDF to assist you (they are all free to download). Doing research requires long hours of hard work and patience, and sometimes the results do not even go the way you planned them to. The quality of data you compile and your eventual analysis of the said data are not the only determinants on creating a successful research study, as you also need to have a good research action plan .

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What is an Action Plan & How to Write One [With Examples]

By Danesh Ramuthi , Oct 26, 2023

An action plan is a meticulously structured strategy that pinpoints specific steps, tasks and resources vital to turning a goal into reality. It is extremely useful in any project management.

Crafting an action plan is like plotting a route for a cross-country journey. It’s the strategic map that outlines every step, decision and pitstop needed to reach your ultimate destination.

With a well-thought-out action plan, you’re not just shooting in the dark; you’re making informed, purposeful strides towards your goals. Dive deep with our guide and witness real-world examples that will inspire and guide you.

Need a tool to kickstart your planning? Try out the Venngage business plan maker and explore their extensive collection of action plan templates .

Click to jump ahead:

What is the purpose of an action plan?

When to develop an action plan, 7 components of a actions plan, 15 action plan examples.

How to Write an action plan?

Final thoughts

An action plan serves as a strategic tool designed to outline specific steps, tasks and goals necessary to achieve a particular objective.

Its primary purpose is to provide a clear roadmap and direction for individuals, teams or organizations to follow in order to efficiently and effectively accomplish their goals.

Action plans break down complex projects into manageable, actionable components, making it easier to track progress and stay on course.

Moreover, action plans play a crucial role in fostering accountability and coordination among team members. By assigning responsibilities and deadlines for each task or milestone, they ensure that everyone involved is aware of their roles and the overall timeline, reducing confusion and enhancing teamwork.

Additionally, action plans help in resource allocation, budgeting and risk management by enabling stakeholders to identify potential challenges and plan for contingencies.

Overall, the purpose of an action plan is to transform abstract goals into concrete actions, making them more achievable and measurable while ensuring that the resources and efforts are aligned with the desired outcomes.

Developing an action plan is crucial when you’re looking to achieve a specific goal or outcome. Here are instances when you should consider developing an action plan:

Start of an organization : Ideally, an action plan should be developed within the first six months to one year of the start of an organization. This initial plan lays the groundwork for the future direction and growth of the entity.
Project initiation : At the start of any project, an action plan helps to clearly define the tasks, responsibilities, and timelines.
Goal setting : Whenever you or your organization sets a new goal. Action plans transform these goals from abstract ideas into concrete steps.
Strategic planning : For long-term visions and missions, action plans break down the journey into manageable pieces, each with its timeline and responsible parties.
Performance improvement : If there are areas where performance is lacking, whether it’s personal or organizational, an action plan can outline the steps needed to elevate performance.

An action plan is a detailed outline that breaks down the steps necessary to achieve a specific goal. Here are the typical components of an action plan.

1. Objective or Goal

The cornerstone of your action plan is the objective or goal. This should be a clear and concise statement outlining the desired outcome or result. Having a well-defined objective provides a direction and purpose to the entire plan, ensuring all tasks and actions are aligned towards achieving this singular aim.

2. Tasks or Actions

Once the objective is set, the next step is to list down the specific tasks or actions required to achieve this goal. These tasks should be broken down into detailed steps, ensuring no essential activity is overlooked. The granularity of these tasks can vary based on the complexity of the goal.

3. Set deadline

For each task or action, set a realistic and achievable deadline. This timeline ensures that the plan stays on track and that momentum is maintained throughout the execution. It also allows for monitoring progress and identifying potential delays early.

4. Resources needed to complete the project

It’s crucial to recognize and list the resources you’ll need to complete the tasks. This can encompass financial resources, human resources, equipment, technological tools or any other assets. Identifying these early ensures that there are no bottlenecks during execution due to a lack of necessary resources.

5. Person responsible

Assign a person or a team for each task. This designation ensures accountability and clarity. When individuals are aware of their responsibilities, it reduces overlap, confusion and ensures that every task has someone overseeing its completion.

6. Potential barriers or challenges

Every plan will face challenges. By anticipating potential barriers or obstacles, you can be better prepared to address them. This proactive approach ensures smoother execution and less reactionary problem-solving.

7. Measurement of key performance indicators (KPIs)

Determine how you’ll measure the success of each task or the plan overall. KPIs are tangible metrics that allow you to gauge progress and determine whether you’re moving closer to your goals and objectives. They offer a quantifiable means to evaluate success.

Action plans serve as blueprints, guiding the steps and resources needed to achieve a specific goal.

They come in various formats, tailored to different scenarios and objectives. Here, we present a range of action plan examples that cater to diverse purposes and situations.

From business strategies to simple task lists, these examples illustrate the versatility and importance of well-structured planning.

Business action plan example

A business action plan is essentially a strategy roadmap, meticulously tailored for realizing broader business objectives. By crafting a solid action plan, businesses can channel their resources, manpower and strategies in a direction that harmonizes with their larger vision.

Key to this plan is the identification and alignment of steps that resonate with the company’s comprehensive strategy, ambitions of growth and aspirations for operational enhancements.

While this might entail a myriad of specific steps based on unique business goals, some common elements include setting clear key performance indicators (KPIs), undertaking a thorough SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis to grasp the current business landscape and establishing a timeline to keep track of progress.

Furthermore, allocating responsibilities to team members or individuals ensures that every aspect of the strategy has a dedicated focus. Budgeting, essential to the success of the action plan, ensures that every initiative is financially viable and sustainable.

Regular reviews and iterations based on feedback and changing market dynamics keep the action plan agile and relevant.

Related: 5 Steps to Create an Actionable Employee Development Plan [with Templates & Examples]

Company action plan example

A comprehensive company action plan serves as the strategic linchpin, ensuring a coherent and coordinated approach to realizing organizational goals. Central to this plan is the incorporation of rigorous market research and analysis, which provides insights into consumer behaviors, market trends and potential opportunities.

Equally vital is the focus on product development and procurement, ensuring that the offerings align with market demands and stand out in terms of quality and relevance.

Alongside, adept legal and financial management safeguards the company’s interests, ensuring compliance with regulations and prudent fiscal oversight.

Simple Green And Orange Company Action Plan

Moreover, the essence of any successful company action plan lies in its sales and marketing strategies. These define how the products or services are positioned and promoted in the market, ensuring visibility and engagement with the target audience.

Navy And Yellow Modern Minimalist Action Plan

However, while acquisition is crucial, retention plays an equally significant role. Hence, impeccable customer service and nurturing relationships become indispensable components, fostering loyalty and ensuring that clients remain ambassadors for the brand long after the initial transaction.

Related: 30+ Project Plan Examples to Visualize Your Strategy (2023)

Sales action plan example

A well-structured sales action plan serves as the backbone for systematic and efficient progress. Central to this plan is the identification and utilization of the most effective sales channels, whether they are direct, online or through third-party avenues.

Strategic Food Sales Action Plan Template

Clarity on the products and services on offer, combined with their unique selling propositions, facilitates tailored and resonant sales pitches.

Budget considerations ensure that resources are judiciously allocated, balancing the act between expenditures and potential returns. This financial prudence is complemented by setting realistic sales projections, which act as both a motivational target and a yardstick for success.

Timelines, or proposed deadlines, infuse the process with a sense of urgency, ensuring that the momentum of the sales drive is maintained.

However, the true measure of the action plan’s efficacy lies in its key performance indicators (KPIs). These metrics, be it lead conversion rates or customer retention figures, serve as tangible markers, highlighting the plan’s strengths and signaling areas that might require recalibration to increase sales.

Food Retailer Sales Action Plan Template

Corrective action plan example

The essence of a corrective action plan lies in its meticulous structure, tailored to address and rectify deviations or inefficiencies identified within an organization. At its core, each action item serves as a focal point, detailing specific areas or processes that require intervention.

Accompanying each action item is a clear description that provides a comprehensive understanding of the issue at hand.

However, merely identifying a problem isn’t enough; delving deep into its origins through root cause analysis ensures that solutions target the fundamental issues, rather than just addressing superficial symptoms.

This analysis then paves the way for defining the corrective action, a tangible step or series of steps designed to mitigate the identified problem and prevent its recurrence.

Besides, to ensure the plan’s effectiveness, assigning a responsible person to each action item is paramount. This individual or team is entrusted with the task’s execution, ensuring accountability and focus.

The status of each action keeps stakeholders informed about the progress, be it in the planning phase, ongoing, or completed.

Lastly, setting a due date for each corrective action introduces a sense of urgency and purpose, ensuring that issues are addressed in a timely manner, minimizing disruptions and maximizing operational efficiency.

Simple action plan example

A simple action plan strips away the layers of complexity, offering a concise and direct approach to achieving a goal or addressing an issue. This type of plan is characterized by its straightforward structure, devoid of extraneous details, yet powerfully effective in its clarity.

It is specifically designed for tasks or objectives that don’t necessitate elaborate strategies or multi-layered approaches.

White and Red Simple Corrective Action Plan

The core components of a simple action plan usually include a clear statement of the task or objective at hand, followed by a sequence of actions or steps to be taken.

Each step is described succinctly, ensuring that anyone involved has a clear understanding of what is expected. Responsibilities are defined clearly, with each task allocated to an individual or a team, ensuring accountability. Timelines might be integrated, providing a clear framework for completion, even if they’re just broad milestones.

Regular check-ins or assessments, although minimal, might be incorporated to monitor progress.

The beauty of a simple action plan lies in its agility and adaptability, making it particularly suited for individual projects, short-term tasks or situations where a rapid response is required.

How to write an action plan?

Creating an effective action plan is a foundational step towards turning aspirations into tangible results. It provides a clear roadmap, ensuring that each step taken aligns with the overall objective.

Whether you’re aiming to enhance a business process or achieve a personal goal, a well-drafted action plan can be your guiding light. Here’s key steps on how you can craft one:

Step 1: Establish SMART goals: Initiating with a goal that is specific, measurable, achievable, relevant and time-bound ensures you have a clear and focused endpoint in sight. Smart goals serves as the cornerstone for your entire strategic blueprint.
Step 2: Determine necessary tasks: Decompose your overarching objective into smaller, actionable tasks. This modular approach not only makes the mission less daunting but also provides a sequential pathway to goal attainment.
Step 3: Assign essential resources: Depending on the tasks at hand, designate necessary resources, be they human, financial or technological. This ensures that every activity has the backing it needs for successful execution.
Step 4: Prioritize tasks by importance: Not all tasks hold equal weight. Determine the hierarchy of tasks based on their impact on the goal and their time sensitivity. This allows for a systematic progression.
Step 5: Outline timelines and key markers: With tasks in hand, set clear deadlines for each. Introduce milestones, which act as periodic check-ins, ensuring you’re on track and allowing for celebrations of smaller victories.
Step 6: Oversee and modify your strategy blueprint: As you progress, there will invariably be learnings and challenges. Regularly review your plan to make necessary adjustments, ensuring its relevance and effectiveness.
Step 7: Consider ready-to-use templates: If starting from scratch feels overwhelming, lean on structured templates to guide your planning. There’s plenty of business plan softwares and platforms such as Venngage that offer a plethora of action plan templates , tailored to various needs, which can significantly streamline the process.

An action plan is more than just an action steps, it’s a strategic blueprint that bridges the gap between aspirations and realizations.

Through this comprehensive guide, I’ve walked you through the purpose, ideal timings, core components, and practical examples of action plans across various domains.

Leveraging tools of project management , you can track progress, assign tasks and ensure every team member stays on the same page.

It’s not just about setting goals, but about strategically planning every step, ensuring tasks completed align with the larger project goals.

Remember, success isn’t just about having goals but about charting the right course to achieve them

And if you’re looking to supercharge your planning efforts, don’t miss out on the Venngage business plan maker.

Dive into their extensive collection of action plan templates and make your strategic planning both efficient and effective.

Resolving and Preventing Repetitive Problems in Clinical Trials

April Bishay, BA, MBA Senior Manager, Clinical Compliance, MedImmune

Anatoly Gorkun, MD, PhD Chartered MCIPD, Senior Manager, Scientific & Compliance Training, MedImmune

Abstract : Clinical trial findings from audits reveal the same type of problems year after year despite the implementation of quality systems, compliance training, and corrective and preventive action plans. This article provides an overview of the root cause of these problems and how to ensure that corrective and preventive actions are addressing the actual problem rather than its symptoms. Actual case study illustrates some of the common problems in clinical trials.

Introduction

Today, clinical trial professionals are provided with guidelines, regulations, company policies, procedures, and endless amounts of training to help them with the conduct of clinical trials.

Despite all the training one receives or all the guidelines, regulations, company policies, and procedures in place to assist with the conduct of a clinical-trial, problems including unanticipated situations or safety issues may arise (Table 1). Clinical research professionals are often unable to give their full attention to every detail of the study due to the speed in which the trial progresses, the strain on company resources, or many of the other day-to-day factors that impact ones’ time and attention.

An auditor is at an investigator’s site performing a clinical trial audit. The auditor reviews the site documentation including personnel signature/delegation forms and source documents and notes the following issues:

Delegated responsibilities were assigned to everyone regardless of their role on the study. The site personnel signature/delegation form was not completed correctly or in a timely manner. For example, the dates for the clinical investigator’s signature were changed and updated. Some of the dates were after the person began conducting protocol-required procedures.
Dr. MJ signed the electronic version of a physical exam for Subject 1285’s visit for Cycle 1, Day 1. Dr. MJ, however, was not listed on the delegation log to perform protocol-required procedures.
The number of site personnel listed on the signature/delegation form far exceeded the number of people who actually worked on the clinical trial.

Additional background related to the audit finding:

No protocol deviations or violations were recorded in the monitoring reports for these issues. The monitor identified the issues only as follow-up actions and has not seen the clinical investigator in months.
Communication between the monitor and the clinical investigator occurred primarily through follow-up letters sent after each monitoring visit.
Issues noted in the audit finding had been ongoing for approximately one year.
The clinical research site routinely lists everyone working in their department on the Form FDA 1572 rather than determining which staff members actually work on a specific clinical trial.

Corrective and Preventive Action P lans

A corrective and preventive action (CAPA) plan is a series of actions taken to resolve a compliance issue, and most importantly, to prevent further recurrence (Table 2). A CAPA plan will focus on the immediate noncompliance and the broader scope of the problem. It involves investigating and understanding the issue, correcting the issue, and preventing the root cause. CAPAs can be used for audit or inspection observations, compliance improvement, or risk mitigation.

The first step in developing a CAPA plan is to identify the issue. Issues can include deviations or violations, findings identified through quality control, as well as audit and inspection findings. Quality issues may be isolated or they may have a broad impact across trials and programs and can represent:

A single occurrence or a cluster of occurrences
Gaps indicating noncompliance with regulations, policies, and/or procedures
Risk to subject safety and/or data integrity, and, as a result, risk to the company’s license to operate.

After identifying the issue, one must evaluate its severity and impact by considering:

The potential for a broader impact across clinical trials
The impact on company processes and procedures
How the issue will impact other departments
Whether the issue requires immediate action

For example, an email from an investigative site with the subject’s name has just arrived. Should immediate action be taken or should clinical research professionals wait for a CAPA? In this specific case, the clinical research professional should act immediately. They must redact the subject’s name because it violates data privacy regulations and the Health Insurance Portability and Accountability Act (HIPAA). The recipient must also discuss the problem with the sender of the email and report it internally, as required by company policy.

Root Cause Analysis: Getting to the Real Issue

A root cause analysis (RCA) is a method used to examine and identify the underlying reason for why an issue has occurred. Performing an RCA allows one to identify effective actions to correct or eliminate the cause and prevent the issue from recurring.

Case Study (Continued)

Now we return to the case study.

The monitor performed the root cause analysis on the audit findings which states:

“The site staff was not updating the site delegation log upon completion of training.”

This, however, is not the real root cause of the issue. It is a symptom. How do we know this is just the symptom of the issue? Simple. We can still ask the question “Why?”

Why hasn’t the site delegation log been updated?
Why are the other issues in the audit finding not addressed with this root cause?

The root cause identified by the monitor does not address the real issue. It is only a brief observation without knowing why the problems are occurring.

There are several different methods available to help us identify the real root cause of an issue. One of the most common and simplest methods used is the 5-Whys method. The method allows one to explore the cause and effect of an underlying problem by asking the question “Why?” five times. Asking a “Why?” question may lead to another “Why?” question until “Why?” can no longer be asked. One may not necessarily need to ask five “Why?” questions to identify the root cause. One may be able to get the root cause with three “Why?” questions, for example, while other times it may take more than five.

One of the findings from the case study audit involved changed dates. The clinical investigator’s signature dates had been changed and some dates were recorded after the staff began clinical trial-related activities. Now let’s try to determine the root cause by using the 5-Why method.

Question #1: Why were the clinical investigator’s signature dates changed?

Site’s Response: The study coordinator asked the clinical investigator to update the delegation log at the start of the study. The clinical investigator made updates to the log and updated the signature dates.

Question #2 : Why were some dates recorded after the person started protocol-related procedures?

Site’s Response: The clinical investigator was busy and focused on other priorities, wrongly assuming that the study coordinator was keeping up with this activity.

Question #3: Why did the clinical investigator assume that the study coordinator was keeping up with this activity?

Site’s Response: The clinical investigator feels that this is an administrative task; therefore, he assumed that the study coordinator was keeping up with all of the paperwork.

Question #4: Why didn’t the study coordinator follow up with the clinical investigator to remind him to update the form?

Site’s Response: The study coordinator was too busy to follow up on general study paperwork due to the rapid enrollment of subjects into the study, prioritized work related to subject enrollment, and ongoing subject visits.

Question #5: Did the study coordinator ask for assistance?

Site’s Response: No.

Question #6 : Why hasn’t the study coordinator asked for additional assistance?

Site’s Response : There is no room in the department budget to hire additional staff.

Question #7: Why hasn’t the investigator slowed recruitment to allow the study coordinator to catch up?

Site’s Response: Study recruitment is going quicker than expected. The clinical investigator is required, by contract, to enroll a defined number of subjects; therefore, subject enrollment cannot slow down.

Other findings from the case study audit were the incorrect assignment of delegated responsibilities and the number of site personnel listed on the delegation log exceeded the number that worked on the trial. The audit report states that the same activities were assigned to everyone regardless of their role on the study. The following questions can be asked to identify the root cause:

Question #1: Why were physician-related activities, to be conducted only by the clinical investigator or sub-investigators, delegated to non-physician roles on the delegation log?

Site’s Response: Physician-related activities are not being conducted by non-physicians. These activities were assigned in error.

Question #2: Why were there so many people listed on the delegation log?

Site’s Answer: We routinely list everyone on the delegation log rather than those who actually work on a trial.

Question #3: Why was Dr. HS left off of the delegation log when it is routine to list everyone?

Site’s Response: The delegation log was not routinely updated to keep up with new and departing staff.

Question #4: Why are you unable to perform ongoing maintenance of the delegation log?

Site’s Response: We were unable to keep up with both recruitment activities and administrative tasks.

We can continue asking “Why?” questions after Question #4, but this would only lead back to workload issues, which have already been questioned previously.

Another finding from the case study audit showed that the monitor had followed up on issues previously, yet some of the issues have remained open for over a year.

Question #1: Why do the issues remain open when recoded over a year ago?

Monitor’s Response: Due to high recruitment, the study coordinator struggles to keep up with the work on the study.

Question #2: There is no evidence that you have escalated this to your (CRO) study manager. Why haven’t you escalated this issue to your manager?

Monitor’s Response: The issues were documented for follow-up in monitoring reports and follow-up letters after each site visit. I was not aware of the need to escalate site workload issues to my (CRO) study manager. I assumed that my study manager was aware of the issue, and I would have said something, especially because it is my study manager who reviews my monitoring visit reports for this site.

Question #3: Why haven’t you escalated or reported the lack of investigator oversight/study management as a potential quality issue?

Monitor’s Response: I was unaware that this would qualify as a potential quality issue. I only thought that it was an issue for follow up.

Information gathered while performing the 5-Whys method clearly shows that there are communication problems between the monitor, clinical investigator, and site staff. Communication problems are also present between the monitor and the CRO study manager. Poor communication within the CRO study team kept the issue from being escalated to the sponsor. The sponsor could have tried to help resolve issues at the site if the sponsor had been informed. Unfortunately, the sponsor was only made aware of the issue when the audit report was released.

The root cause analysis provides information that can be used to develop corrective and preventive actions. Common themes identified in the case study audit include (Table 3): (a) site staff have a high workload due to rapid subject enrollment, (b) there are no site processes indicating who is responsible for performing tasks, (c) poor delegation of study tasks as assumptions are made about who does what, (d) lack of adequate oversight by the clinical investigator, (e) the monitor did not provide sufficient follow up, and (f) poor communication between all parties.

Corrective Actions

Developing effective corrective actions should eliminate the cause of a detected non-conformity or other undesirable situation or event.

The below are some corrective actions that can be put into place to help address issues identified during the audit. There are more corrective actions that can be implemented, but here are a few to start with:

At the next monitoring visit, the monitor will review the site delegation log with the clinical investigator and the study coordinator to ensure that all staff members who have contributed to the study are listed and responsibilities are appropriately delegated. This activity will be documented in the monitoring visit report and in the follow-up letter to the site.
The monitor, clinical investigator, and site staff will discuss responsibilities for performing various study tasks and address workload issues. Information from the discussion will be provided to the CRO study manager and sponsor to see if additional support can be provided. This activity will be documented in the monitoring visit report and in the follow-up letter to the site.

Preventive Actions

Implementing corrective actions alone will not prevent non-compliance. Preventive action must be taken to eliminate the cause of non-compliance or other undesirable potential situations or events.

Developing effective preventive actions:

Should prevent issue(s) from occurring or recurring
May require changes to a process in order to correct a weakness
Must target the underlying root cause identified in the root cause analysis
Should aim to ensure that the issue will not be repeated.

Preventative actions for the case study should focus on the common themes that came out of the root cause analysis: (a) site staff have a high workload due to rapid subject enrollment, (b) there are no site processes indicating who is responsible for performing tasks, (c) poor delegation of study tasks because assumptions are made about who does what, (d) lack of adequate oversight by the clinical investigator, (e) the monitor did not provide sufficient follow up, and (f) poor communication between all parties.

A few examples of preventive actions include:

The monitor will schedule the next monitoring visit while meeting with the clinical investigator and site staff in an attempt to improve meeting attendance with the clinical investigator.
At each monitoring visit, the monitor will speak with the study coordinator or clinical investigator to see if there have been changes in study staff, to see about completion of training, and to review the delegation of study procedures with the clinical investigator.
The clinical investigator and the study coordinator will dedicate time for the review of site activities with an agreed-upon frequency.
The monitor will receive training/mentoring on effective communication, escalation, follow-up, and issue resolution. The monitor’s manager should periodically check on the monitor to see if additional training and mentoring are required to improve communication skills and issue resolution.
The monitor and the clinical investigator will agree on the study oversight process at the investigative site, utilizing regular review meetings to evaluate current and potential issues, findings, and workload. They will continuously implement the required changes to improve the quality of the study conduct.

Follow-up and Closing the CAPA Checking the effectiveness of implemented corrective and preventive actions is an important part of the CAPA process, especially for issues that are deemed as critical or serious. Continued oversight and monitoring is required to verify that the actions taken have been effective and that the issue does not recur.

In some cases, actions taken may not be effective. In such cases, it is necessary to re-examine the root cause and agree upon additional actions to address the issue.

CAPAs are closed when actions and documentation are completed and corrective and preventive actions have effectively resolved the incident and mitigated the risk of recurrence. This requires evaluating the effectiveness of the actions taken and whether goals were achieved.

Documentation to Support the CAPA When a CAPA plan is implemented due to an audit or inspection, one must be able to show the range of activities taken to address the issue. CAPA documentation must be maintained to demonstrate planning and implementation in addition to providing evidence of decisions made and actions taken.

Documentation can include:

A factual description of what happened
Root cause analysis description
Immediate and planned actions
People responsible for ensuring that the actions are taken
Timelines for completion
Documentation to support corrective and preventive actions implemented.

Documentation must be updated with ongoing actions until the CAPA plan is closed. Supporting documentation must be always available.

In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA) may consider repetitive problems as a serious breach of Good Clinical Practice (GCP). For example, the inclusion and exclusion criteria in a protocol states that a procedure must be completed and results must be within a given range. The site enrolls a subject into a trial and administers investigational product prior to receiving the results. Fortunately, the subject’s results were received and were within the range specified in the protocol. The subject was not harmed in this instance, but there was the potential to harm the subject should the results have shown that the subject was not suitable for participation in the trial. Enrollment of a subject prior to confirming that all inclusion and exclusion criteria were met would be documented as a protocol violation, and discussion would occur between the CRO and sponsor on how to proceed with this subject and the site. Would this situation need to be reported to the regulatory agency as a serious breach? Most likely not, but if the site should do this again, the CRO and sponsor would need to consider if the site’s actions fit the criteria of a serious breach.

Successful issue resolution depends on identifying the real cause of the issue by performing a root cause analysis and finding effective corrective and preventive actions. Successful resolution involves the development of a corrective and preventive action plan that addresses the actual root cause of the issue. The CAPA is closed when the corrective and preventive actions have effectively resolved the issue and prevent it from recurring in the future. Continuing process improvement is vitally important because minor issues can grow and may have a negative impact on the safety of patients, the study results, and the reputation of the CRO and sponsor.

TABLE 1: Reasons for Repetitive Problems in Clinical Trials

Unexpected situations like safety issues may arise
Lack of attention due to other priorities
Logistical problems like shipping, etc.
Technical issues with equipment, etc.
Limited amount of control over the people they work with
Investigative site
Contract research organization
Laboratories and other vendors

TABLE 2: Corrective and Preventive Action

Resolve a compliance issue or incident
Prevent further recurrence of the issue
Investigating
Understanding
Preventing the root cause
Audit or inspection observations
Compliance improvement
Risk mitigation
Identify the issue
Evaluate the impact
Conduct root cause analysis
Develop the corrective action
Develop preventive actions
Follow up and close

TABLE 3: Common Themes in the Case Study Root Cause Analysis

The study coordinator and the clinical investigator have a high workload
No site processes or proper delegation: who does what?
More oversight of site activities required by the clinical investigator
Lack of follow-up by the site and the monitor
Communication problems:
At the site
Between the monitor and the clinical investigator and site staff
Between the monitor and the CRO study manager
Communication
Escalation of issues
Follow-up on issues
Resolution of issues

TABLE 4: Successful Resolution of an Issue

Identify the actual root cause
Develop a corrective and preventive action plan addressing the actual root cause
Close the case upon agreement that the corrective and preventive actions have effectively resolved the issue
Continually improve processes

12 thoughts on “Resolving and Preventing Repetitive Problems in Clinical Trials”

One of the most important causes of problems in clinical trials is a limited amount of influence over people you work with. Additionally, escalation of issues is often corrective & not preventive. Better oversight of clinical trials by the monitor & a pro-active PI/QI can be helpful in prevention & mitigation of these issues.

Very informative post related to clinical research. It is great help for my new project .By reading this article, I learn some important things that I need to improve. I continuously check this site for regular updates in field. Thanks for putting top notch content in article. I would like to be here again to find another masterpiece article.

Thank you for your useful addition, Aditya. I agree with what you say. Lack of influence over the people we work with might be challenging, at the same time it depends on a particular situation. If it concerns compliance, we may want to try to influence those people in an assertive way, regardless of their role’s hierarchy. With regards to escalation of issues it depends on what and when is escalated, if that’s already existing problem or a potential issue. In the first case it will be corrective action and preventive in the second one. That’s the idea of risk-based-monitoring, to start acting before a problem occurs.

When significant deviations or noncompliance occur in research, it is important to identify the causes of the problem so that they can be resolved to prevent further noncompliance. There can be multiple reasons or causes that contribute to one single problem. Conversely, there may be multiple methods to resolve each cause. The root cause is the initiating, most basic cause of a problem that may or may not lead to a chain of causes or other problems. Eliminating the root cause should prevent recurrence of the problem.

Very informative post.

Clinical Trials do get neglected at some parts because of which some glitches take place. This article gives an overall view where improvement is needed. Very Nice article. Keep sharing your information and keep us updated.

In this scenario I am confused about the definitions of corrective and preventive action. I thought that corrective action involves both correction which is rectifying the problem plus corrective action which includes how to prevent recurrence versus preventive action which involves resolution or elimination of root causes of potential problems to prevent occurrence. Essentially for corrective action there is a problem that has occurred and for preventive action it’s to protect against a potential problem that has not occurred.

Hey thanx for sharing this blog over here. It seems useful to start career in clinical research. We will look forward for more updates.

great article.

Informative

Very Informative post for every clinical trial professional.

How do Clinical Research Coordinators learn Good Clinical Practice? A mixed methods study of factors that predict uptake of knowledge

Jessica t. mozersky.

Washington University School of Medicine, St. Louis, Missouri, USA

Alison L. Antes

Kari baldwin, michelle jenkerson, james m. dubois, associated data.

Good Clinical Practice (GCP) is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent NIH policy mandates GCP training for all investigators and staff involved in NIH funded clinical trials, yet approaches to GCP training vary widely. There is limited data on GCP knowledge among the clinical trial workforce and no evidence regarding effective methods to learn GCP.

We used an exploratory sequential mixed methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple choice test of GCP knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with GCP knowledge were entered into a multiple regression analysis to identify unique predictors of GCP knowledge. We controlled for verbal-numerical reasoning and learning orientation.

During qualitative interviews, clinical research coordinators reported that formal GCP training had value but they simultaneously emphasized the importance of experience, day to day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in GCP knowledge scores: Years of experience as a Clinical Research Coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order).

Conclusions

The duration and richness of experience as a Clinical Research Coordinator were the strongest predictors of GCP knowledge; a finding consistent with our exploratory qualitative interview results. Our findings suggest formal online and face-to-face training has a minimal influence on GCP knowledge. The type of training – whether online or face to face – does not make a significant difference in GCP knowledge scores. Much of the variance in GCP knowledge remains unexplained, calling for further research in this area.

Background and Aims

Good Clinical Practice (GCP), first developed by the International Conference for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use in 1996, is an international standard for the design, conduct, and reporting of clinical trials to ensure ethical and scientific integrity. 1 The principles of GCP have been adopted into law in various countries and in Europe as the EU Clinical Trials Directive. 2 In the United States, the Food and Drug Administration uses GCP as guidance rather than formal law. 3 Compliance with GCP is meant to protect the rights and safety of participants, ensure that trials are conducted with rigor, meet regulatory requirements, and safeguard the integrity of data. These objectives must be achieved to acquire trustworthy evidence regarding the risks and benefits of treatments and interventions, while protecting participants and preserving public trust in research. 4 In this sense, GCP is an essential element in realizing the overall social benefits that clinical trials can provide. Methot et al. aptly describe GCP as a “system of shared responsibilities.” 5

Clinical trials have become increasingly complex often involving multiple sites across different countries as well as complex trial designs, protocols, and interventions. As a consequence, clinical trials are subject to heavy regulations, governance, and monitoring rules and are among the most regulated activities globally. 5 – 10 According to the Declaration of Helsinki, research must be carried out by individuals with appropriate training and qualifications in clinical research. 11 GCP training is often mandated, making GCP the “bible of trial conduct” for clinical trial personnel. 12 Recent NIH policy, effective March 2017, mandates GCP training for all investigators and staff involved in NIH funded clinical trials. 13 According to the NIH, GCP training should be refreshed every 3 years and is defined as a “class or course, academic training program, or certification”. 13

The goal of GCP training is to ensure team members have the same basic foundational knowledge, yet there are no consistent or formalized educational requirements that define an appropriate level of qualification. 9 , 14 Training requirements tend to be general and contain few details on what key criteria should be included. 10 Approaches to GCP training include online modules that average 45–60 minutes or longer, face-to-face trainings from one time only to multiple sessions, and formal certification programs offered through professional organizations that can take more than a year to complete. 9 , 10 GCP trainings are offered by professional organizations, industry, government, and Clinical and Translational Science Award (CTSA) hubs. 14

While principal investigators are ultimately responsible for all ethical and regulatory aspects of a clinical trial, clinical research coordinators are integral to the clinical trial research enterprise. 15 Clinical research coordinators work closely with principal investigators and are involved in developing protocols, writing consent forms, recruitment, informed consent, and data management. Over time, the role of clinical research coordinators requires increasing autonomy, accountability and responsibility. 16 Clinical research coordinators are also the main point of contact for subjects during a trial, and act as liaisons between study subjects and principal investigators. 15 Thus, they are heavily involved in the day to day aspects of clinical trials and ensuring GCP requirements are met.

There have been several recent efforts to standardize requirements for GCP training and identify core competencies to address gaps in current training. 9 , 10 , 14 , 17 The National Center for Advancing Translational Science sponsored the “Enhancing Clinical Research Professionals’ Training and Qualification Project” which consisted of a consortium of all CTSAs, and aimed to establish a “foundation of GCP training expectations for all clinical trials work.” 9 This process included establishing a Joint Taskforce for Clinical Trial Competency that identified 8 core competencies for principal investigators and clinical research coordinators, with 51 corresponding specific sub-competencies across the 8 competency domains. 10 , 14 CTSA hubs are now implementing mandatory GCP training for all personnel involved in NIH funded clinical trials, to be refreshed at least every 3 years, but institutions can choose which training programs to offer as long as they meet the minimum requirements laid out by the “Enhancing Clinical Research Professionals’ Training and Qualification Project”. 9

While training in GCP is considered necessary for responsible and ethical management of clinical trials, there is limited data on GCP knowledge among the clinical trial workforce, or evidence about the most effective means to learn GCP. 10 , 18 , 19 In light of the recent NIH mandate, and increasing attention regarding assessment and standardization of GCP training, this study examined GCP knowledge among clinical research coordinators working in the U.S., and explored the association of knowledge with work experience, face-to-face and online training, certification, and other clinical research coordinator characteristics.

The aims of this mixed methods study were: 1) to explore through qualitative methods clinical research coordinators’ perspectives and experiences regarding learning GCP and, 2) to use testing and quantitative survey methods informed by our qualitative findings to identify what factors predict knowledge of GCP among clinical research coordinators. Such information was meant to inform the evaluation of current approaches to GCP training.

We focused on clinical research coordinators because they play an essential role in the day to day conduct of clinical trials including ensuring consistent data collection, informed consent, retention of trial participants, and encouraging compliance with regulations. 7 , 20

Study design

This exploratory sequential mixed methods study included qualitative interviews with clinical research coordinators at a research-intensive academic medical center in the U.S. to explore their experiences and perspectives about learning GCP. 21 This data informed development of our quantitative survey. Following this preliminary exploratory study, data were collected from clinical research coordinators using a cross-sectional survey and a newly developed test of GCP knowledge at three research-intensive medical centers that have CTSAs.

Ethical review

This project was approved as an Exempt study by the IRB at each of the three participating CTSA sites. At two sites, participants were presented with the informed consent document electronically and were asked to indicate consent before proceeding to the online survey and GCP test. A third site did not require a consent form as completion of the survey was considered consent to participate. Participants were informed that data would be confidential, and it would not be possible to identify any individual taking part.

Qualitative interviews

We conducted 18 semi-structured qualitative telephone interviews with clinical research coordinators (75% female) of varying experience levels (1–32 years) who had completed online GCP training modules. In light of the limited data regarding GCP knowledge, interviews explored prior experience and satisfaction with formal online GCP training, informal methods used to learn GCP outside of formal training, what clinical research coordinators think are the most effective methods for learning GCP, and their top recommendation to a new clinical research coordinator for how to learn GCP. The purpose of the qualitative interviews was to inform development of the quantitative survey. The emphasis individuals placed on experience and practice informed the work experience section of the 28-item survey to capture a breadth of variables about work experience that might predict GCP knowledge.

See Supplemental Materials for a full description of methods, qualitative findings, and the interview guide.

Quantitative cross-sectional survey and GCP knowledge test

Sample and procedure.

Criterion sampling was used to enroll clinical research coordinators for drug, device, or biologic trials with a range of experience at three academic medical centers with CTSAs. We sought a large and diverse enough sample to explore a variety of predictor variables. Power analysis indicated that assuming a power of .90 and an adjusted alpha of .01, assuming we ran up to 5 models, even a modest effect (Cohen’s f 2 = .05) could be detected in a multiple regression model with 14 predictors in a sample size of 616. Thus, we aimed to obtain a sample size of 600.

Email distribution lists of clinical research coordinators (and sometimes other clinical research staff because clinical research coordinators job titles may differ) employed at each site were used to send recruitment messages. A representative at each institutions’ CTSA sent an email indicating the opportunity to participate in an online survey examining experiences and prior GCP training followed by GCP knowledge questions. Participants were told the study would take 30–40 minutes. The emails included a link to the online study administered via Qualtrics. Participants were instructed to complete the survey only once. The survey was administered with forced-choice to ensure participants responded to all parts.

Across sites, 2415 emails were sent to clinical research staff. Three follow up emails were sent as reminders at approximately one-week intervals. To confirm eligibility, the first questions of the survey screened to ensure the potential respondent were clinical research coordinators and that they worked in drug, device, or biomedical intervention clinical trials involving human subjects. Survey participants were compensated $20 upon completion of the survey, and were eligible to win one of three raffle prizes of $100 per site. Our response rate was approximately 33% of all eligible individuals. We estimated our response of 1884 eligible individuals by adjusting the total number of emails sent across all sites ( N =2415) by the percentage of people who responded that they were not eligible because they were not clinical research coordinators (22% overall).

Survey instruments and GCP knowledge test

The survey instruments included: (a) a 28-item survey of work and training experience (and basic demographics) developed by our research team and informed by qualitative interview findings, (b) a 32-item GCP knowledge test developed by our research team, (c) an existing 5-item learning orientation scale, 22 and (d) an existing 13-item, timed measure of verbal-numerical reasoning; 23 instruments were completed by respondents in this order.

The survey of clinical research coordinator work and training experience asked participants to characterize their prior and current work experience coordinating trials. Before administering the survey, we conducted four cognitive interviews with clinical research coordinators to confirm item clarity, and revised items as necessary. Years of work experience as a clinical research coordinator was a continuous variable. Participants selected “all that apply” for types of trials coordinated (drug, device, biologic, or other), coordinator responsibilities (recruitment/enrollment, informed consent, data collection, data entry, regulatory activities, supervising others), and experience, if any, with different types of audits (FDA, institution, study sponsor). These responses were summed to create 3 variables: number of trial types coordinated, number of coordinator responsibilities, and number of types of audits. Number of principal investigators supported in current role and number of trials coordinated in the last 12 months were ordered categorical responses. Finally, 3 dichotomous (yes-no) questions asked participants to indicate if they coordinated federally-funded trials, industry funded trials, and if they had experience serving on an IRB.

Next, participants characterized their formal education and training experience. Respondents indicated their academic degrees and formal certifications held. They estimated the number of online and face-to-face hours of formal GCP training they had participated in over their career so far. We provided instructions to help guide respondents when making their estimate. Our team has previously used this method to estimate prior training hours among researchers. 24 Feedback on the items from the cognitive interviews of the survey items indicated that clinical research coordinators felt they could generate an estimate using approximations such as 10-hour intervals.

The GCP knowledge test included 32 multiple-choice items developed by our team. 25 All items consisted of a stem and four response options consisting of one best answer and three plausible distractors. The competency domains reflected on the test included clinical trial operations, study site management, ethical and participant safety considerations, and data management and informatics. The items were written according to best practices for multiple-choice items and demonstrated adequate validity and reliability. 26

We employed an existing, validated 5-item learning orientation scale . 22 A learning orientation reflects a desire to learn new skills, master new situations and improve competence in work settings. 22 It was measured as a control variable, as learning orientation may affect knowledge gained from training and learning opportunities on the job; thus we wanted to control for its potential association with GCP knowledge. Participants indicated their agreement to statements such as, “I enjoy challenging and difficult tasks at work where I learn new skills,” using a 7-point Likert scale from 1 ( strongly disagree ) to 7 ( strongly agree ). The Cronbach’s alpha coefficient was .76 in this sample. The scores used in analysis were the average of the 5 items.

We included a verbal-numerical reasoning measure 23 also as a control variable when modeling the relationship of GCP knowledge to experiential and individual variables, as verbal-numerical reasoning could affect learning and knowledge acquisition, in addition to performance on a test-taking task. The 13-item measure presented verbal and numerical problems and tasked respondents with answering as many as possible in 2 minutes (skipping any they wished). The test has been administered to over 500,000 healthy participants in the UK Biobank 23 and has a Cronbach’s alpha coefficient of .62 based on data from approximately 112,000 UK Biobank participants. 27 Correct answers are summed, thus the maximum possible score is 13. In this sample, the alpha coefficient was .85.

Data analysis

Qualitative interview data were analyzed using structural coding (See supplemental materials ). 28

Statistical analysis was performed in IBM SPSS Statistics for Windows, version 24.0, released 2016 (IBM Corp., Armonk, NY, USA). Data were downloaded from Qualtrics and imported into SPSS. The accuracy of the data import was verified before performing analysis. There were no missing data, as force-choice responding format was used. We excluded 3 cases from the dataset because a combination of low completion time (< 10 minutes) and extreme low outlier scores on the GCP test (≤37% correct) suggested insufficient effort responding. Respondents were asked to complete the study only once; but 8 individuals submitted two payment forms available at the end of the anonymous link. These data could not be identified for removal.

Descriptive statistics describe the participants’ work characteristics, education and training, and GCP knowledge test scores. We examined bivariate relationships of all potential predictor variables with GCP knowledge scores, using Pearson’s, Spearman’s, or point-biserial correlations depending on the measurement scale of the variable. We set our p-value for statistical significant at p < .01 for consideration of correlations for inclusion in regression.

Next, we performed multiple regression analysis to identify variables that explained a significant portion of variability in GCP knowledge scores. In a first step of the model, we entered verbal-numeric reasoning scores, learning orientation, and institution as control variables. Variables were candidates for entry as predictors if they were significantly positively associated with GCP scores in bivariate correlations, and were hypothesized to be related (e.g., we did not include race or other demographic variables not hypothesized to explain GCP knowledge). Many variables were significantly correlated with GCP knowledge scores; however, they were also correlated with each other (e.g., number of principal investigators supported and number trials coordinated in last 12 months), presenting the potential for estimation problems created by multicollinearity. Thus, when two potential predictor variables were highly inter-correlated (greater than .50), we selected the one with the highest correlation with GCP knowledge.

Although we wished to compare the distinct effects of online and face-to-face training, we ran four models to examine the stability of the estimates with different predictors in the model, and to address our concern about including both types of training in the same model given the high correlation (rho = .41, p<.001) of online and face-to-face training. In the first model (Model A), online and face-to-face training were both entered as separate predictors; in the second (Model B), only face-to-face training was entered; in the third (Model C), only online training was included; and in the fourth (Model D), total hours of combined (online and face-to-face) training was entered. We examined the standardized beta weights because our aim was to understand the relative importance of each predictor. Finally, we ran a model with no training predictors to compare to Model D. Comparison of the R-squared value for the full model with training to the no-training model allowed us to specify the proportion of variance in GCP knowledge explained by training.

Our qualitative interview findings ( Supplemental Materials ) indicate that the majority of clinical research coordinators did not regard formal training as the most effective method for learning GCP. While individuals did find value in formal training, it was primarily described as providing a refresher, reminder, or baseline knowledge. All individuals emphasized the importance of experiential learning to supplement online training, and the need to get hands on practical experience, observe and ask questions of others, and talk to colleagues.

Responses from 625 clinical research coordinators (Institution I N = 285; Institution II N = 184; Institution III N = 156) were included in the quantitative survey analysis. The demographic characteristics of the sample are provided in Table 1 .

Sample Demographics

The mean GCP knowledge score was 24.8 (SD 3.8), with a range of 7 – 32. The median score was 25 out of 32.

Table 2 presents the descriptive statistics for work experience and characteristics and bivariate associations with GCP knowledge scores. On average, clinical research coordinators had 7 years of experience (SD = 6.6). They coordinated both industry (74%) and federally-funded (72%) studies. While 78% of respondents worked on drug trials, they also coordinated other types of trials including device (35%) and biologic/vaccine trials (26%). Most (83%) were supporting the trials of two or more principal investigators. Clinical research coordinators were responsible for multiple aspects of trial coordination: recruitment, consent, data collection and entry were among the most common activities. Respondents reported having undergone institutional (62%), sponsor (58%), and FDA (21%) initiated audits. A small proportion (5%) have served on an Institutional Review Board (IRB). Years of experience had the strongest association with GCP scores, followed by number of trial types coordinated and industry funding.

Work Experience

As shown in Table 3 , the majority (72%) of clinical research coordinators did not hold a formal certification; 28% were trained nurses. Half had bachelor degrees, and 34% held a master’s degree. A majority reported having 0–10 (45%) or 11–20 hours (22%) of face-to-face GCP training, and 0–10 (41%) and 0–20 (26%) hours of online GCP training. Several education and training variables were associated with GCP scores: certification, hours of online training, hours of face-to-face training all had positive correlations of similar magnitudes.

Education and Formal Training

Verbal-numerical reasoning scores had a mean of 5.6 (SD = 1.6) with a range of 0 – 11 out of a possible 13. This is consistent with the mean of 5.99 (SD = 2.16) reported for approximately 160,000 UK biobank participants (Lyall et al. 2016). Verbal-numerical reasoning was not associated with higher GCP test scores ( r = .03, p = .47). The mean learning orientation score was 6.0 (SD = .70) out of a possible score of 7, with a range of 1 to 7. Learning orientation was not correlated with GCP test scores ( r = .01, p = .80).

The results of the regression shown in Table 4 indicate that years of experience explained the most variance in GCP scores. Coordinating diverse types of trials, coordinating industry funded trials, and being certified were also statistically significant predictors. Hours of online and of face-to-face training were correlated, and thus, when both are entered into a regression analysis, neither significantly predicts GCP knowledge. However, face-to-face training alone did significantly predict a small amount of variance, and the combined total number of hours of training in GCP (in Model D) explained a slightly greater amount of variance in GCP scores, similar in magnitude to certification, but proportion online was not a significant predictor. Certification and total training remain significant even after accounting for years of experience and richness of experience, which were the strongest predictors. Yet, comparison of the R-squared value for Model D (F(11, 613) = 16.08, p < .001, R 2 = 0.224) to a no-training model, (F(9, 615) = 18.89, p < .001, R 2 = .217), indicates that adding training to the model accounts for less than 1% of the variance in GCP knowledge scores.

Regression Analysis Predicting GCP Scores

β = Standardized Beta coefficient; p = p-value; VN = verbal-numerical. Bold variables are those with the largest β’s (≥0.10); thus they explain the most variance in the models.

The exploratory qualitative interview findings indicated that experience, day to day practice, observing peers and colleagues, and having mentors are essential elements to learning GCP. Individuals described the benefits of formal training primarily in terms of an initial introduction to GCP as a new employee, a refresher or reminder of GCP, or as necessary for being in regulatory compliance rather than as their main knowledge source for how they learned to put GCP into practice. This led us to include diverse questions regarding prior experience, type of work environment, and responsibilities.

Our quantitative analysis revealed that years of experience as a clinical research coordinator was the strongest predictor of GCP knowledge. Additional significant predictors include, in descending order, working on diverse types of trials, working on industry funded trials, holding a formal certification, and total hours of training. Training was associated with GCP knowledge, but the effect was small. Our findings suggest that the type of training—whether online or face-to-face—does not make a clinically significant difference in GCP knowledge scores; although face-to-face training performed slightly better in one regression model, it was highly correlated with hours of online training, and the total number of hours clearly explained more variance in levels of GCP knowledge. Overall, the study indicates that the effect of training is minimal, accounting for less than 1% of the variance, even when online and face-to-face training hours are aggregated.

Our findings suggest that learning on the job through day-to-day experience and exposure to diverse clinical research settings (through exposure to more trial types and industry) and rigorous training through formal certifications or degrees contribute to GCP knowledge more than interventions such as online GCP modules or face-to-face GCP training. Clinical research coordinators who work on industry funded trials might be expected to know more (e.g., about FDA processes) and may have more resources available to them (e.g., compliance manuals). As expected, verbal-numerical reasoning was associated with GCP knowledge; the magnitude of this effect was similar to that of training. Thus, we would recommend future studies take into account reasoning when examining GCP knowledge. The learning orientation scale may not have been significant in the models due to range restriction. It is likely that people attracted to this type of work in research share a motivation to learn new things. Thus, it is likely unnecessary to consider this variable in future studies.

Our findings support the Joint Taskforce for Clinical Trial Competency suggestion that online training is insufficient on its own and should be supplemented by additional training and education. 19 Online and face-to-face training modules likely provide a baseline of knowledge, and may be especially important for those who are new to the job. Nevertheless, day-to-day experience and learning on the job, combined with exposure to a diverse work environment through multiple types of trials, are essential to gaining GCP knowledge. This is analogous to training in medicine: While classroom education provides a useful foundation, the practice of medicine is learned largely through clinical experience in diverse, supervised settings.

Our study has several limitations. First, we used a regression model to understand the factors that predict GCP knowledge. This enables us to determine what factors are associated with GCP knowledge and, in combination with our qualitative data, to build a theory of how clinical research coordinators learn GCP. But we were unable to use an experimental (randomized) design or even a quasi-experimental (pre- and post-testing design). In part, this was due to the fact that GCP training became mandatory shortly before our study commenced; it is now a standard part of clinical research coordinator onboarding. However, our design had the advantage of controlling for diverse individual factors (such as verbal-numerical reasoning and learning orientation), and enabled us to explore the association of a wide variety of variables with GCP knowledge. Second, our study relied upon self-reported learning experiences and behaviors. The fact that the relationships between these self-reported behaviors and GCP knowledge were consistently in the directions hypothesized offers some evidence of the validity of this approach, but we did not have a way to verify the information about learning experiences and behaviors. Third, our study was limited to clinical research coordinators working in large academic medical centers with CTSAs, which provide a lot of training opportunities and hire individuals with relatively high levels of education. It is possible that our findings might be different with those working in a larger variety of clinical research settings. Finally, our multiple regression model explained only 22% of the total variance in GCP knowledge scores indicating that other factors are at work and further research is needed.

The present study contributes to the clinical research community’s understanding of some key contributors to GCP knowledge among clinical research coordinators.

The GCP test items have not been published because publishing items and answer keys diminishes their value for testing purposes. The authors will make the GCP Knowledge Test available to those who wish to assess GCP training programs or the knowledge of clinical research associates. The test and scoring guide may be requested on the research team’s test service webpage: [url will be inserted following peer review].

Supplementary Material

Acknowledgements.

We thank Bradley Evanoff, Director, Washington University School of Medicine Institute for Clinical and Translational Science for providing financial support for the project; Yi Zhang, Director, Regulatory Support Core, Washington University School of Medicine Institute for Clinical and Translational Science for serving as a project advisor; Susan Budinger, Associate Director of Research Operations, Duke Office of Clinical Research, Duke University School of Medicine, for coordinating survey distribution; Stephanie Swords, Program Director - Study Coordinator Apprenticeship and Mentoring Program (SCAMP) & Research Coordinator Support Service (RCSS), Johns Hopkins University Institute for Clinical and Translational Research, for coordinating survey distribution.

Grant funding: This project was supported by grants from the U.S. National Institutes of Health, UL1TR002345 and K01HG008990.

Conflict of interest statement : The Author(s) declare(s) that there is no conflict of interest’.

Contributor Information

Jessica T. Mozersky, Washington University School of Medicine, St. Louis, Missouri, USA.

Alison L. Antes, Washington University School of Medicine, St. Louis, Missouri, USA.

Kari Baldwin, Washington University School of Medicine, St. Louis, Missouri, USA.

Michelle Jenkerson, Washington University School of Medicine, St. Louis, Missouri, USA.

James M. DuBois, Washington University School of Medicine, St. Louis, Missouri, USA.

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20 Research Coordinator Interview Questions and Answers

Common Research Coordinator interview questions, how to answer them, and sample answers from a certified career coach.

Congratulations on your upcoming interview for a research coordinator position! You’ve worked hard to get to this point, and now it’s time to show the hiring team why you’re such an ideal candidate.

While every job interview is different, there are certain questions that are likely to come up in a research coordinator interview. To help you prepare, we’ve compiled some of the most common research coordinator interview questions—along with tips on how to answer them. Good luck!

What experience do you have in designing and executing research studies?
Describe a time when you had to manage multiple projects simultaneously.
How do you ensure that the data collected is accurate and reliable?
Explain your understanding of ethical considerations for conducting research.
Are you familiar with any software programs used for collecting, analyzing, and reporting on research data?
What strategies do you use to recruit participants for research studies?
How do you handle difficult conversations with participants or stakeholders?
Describe a time when you had to troubleshoot an issue during a research study.
What methods do you use to ensure that all research protocols are followed correctly?
How do you stay informed about new developments in the field of research?
What challenges have you faced while managing research projects?
How do you prioritize tasks when working on multiple research studies at once?
What strategies do you use to communicate complex research findings to non-experts?
Do you have experience writing grant proposals?
How do you ensure that research results are disseminated effectively?
What techniques do you use to motivate team members to complete their work on time?
How do you handle conflicts between different stakeholders involved in a research project?
What strategies do you use to maintain participant confidentiality?
How do you evaluate the success of a research project?
What would you do if a research study was not producing the expected results?

1. What experience do you have in designing and executing research studies?

Research coordinators are responsible for designing and executing research studies in order to generate meaningful results. They need to know how to gather data, analyze it, and present it in a way that is easy to understand. To ensure that a candidate is qualified for the job, interviewers will ask them to describe their experience in designing and executing research studies. This question allows the interviewer to gauge the candidate’s research skills and experience.

How to Answer:

To answer this question, you should provide a few examples of research studies that you have designed and executed. Explain how the study was conducted and what results were achieved. If possible, mention any challenges you faced during the process and how you overcame them. Be sure to emphasize your analytical skills as well as your ability to work with others in order to get meaningful results from the research study.

Example: “I have a strong background in designing and executing research studies. I recently worked on a project for an international organization that involved conducting interviews with stakeholders from different countries to understand their needs and expectations. Through this process, I was able to identify key areas of improvement and develop strategies to address them. Additionally, I have experience working with survey software such as Qualtrics and SurveyMonkey to design surveys and analyze the results. Overall, my experience has given me the skills needed to create effective research studies and interpret the data accurately.”

2. Describe a time when you had to manage multiple projects simultaneously.

Research coordinators often have to juggle multiple tasks, projects, and deadlines at once. This question is designed to determine if you have the organizational and multitasking skills necessary to successfully manage the job. The interviewer wants to know how you prioritize tasks, handle competing demands on your time, and manage your resources to ensure that all projects are completed on time and with the best results.

To answer this question, you should provide specific examples of how you have designed and executed research studies in the past. Talk about the techniques you used to develop a study plan, collect data, analyze results, and present findings. Describe any challenges you encountered during the process and how you overcame them. Show that you understand the importance of staying organized and on track with all projects. Finally, emphasize the value of your work and how it has contributed to the success of past research initiatives.

Example: “In my current role as a research coordinator at XYZ University, I am responsible for managing multiple projects simultaneously. For example, I recently managed four separate studies on the impact of social media marketing on consumer behavior. To ensure that all deadlines were met, I created an individual timeline for each project and assigned tasks to team members accordingly. I also used a variety of software tools to track progress and provide updates to stakeholders. This allowed me to stay organized and manage competing demands on my time, ultimately ensuring that all projects were completed successfully and on schedule.”

3. How do you ensure that the data collected is accurate and reliable?

Research coordinators are responsible for ensuring the accuracy and reliability of the data collected during a study. This is a critical part of the job, as poor data accuracy can lead to inaccurate results. By asking this question, the interviewer is looking to evaluate your understanding of the importance of data accuracy and your knowledge of the methods and processes used to ensure it.

You should be prepared to discuss the various methods you use to ensure data accuracy and reliability. This could include double-checking all data entry for errors, performing regular quality checks on the data collected, or using standardized protocols and processes when collecting data. Additionally, you may want to highlight any specialized training or experience you have in this area that would make you an asset to the team.

Example: “I understand how important accurate data is to the success of a research project, so I always ensure that all data collected is double-checked for accuracy. Additionally, I have specialized training in quality control and auditing techniques for data collection, which I use to regularly audit our processes and procedures to make sure they are up to date with the latest standards. I also strive to stay informed on any new methods or technologies that could help improve the accuracy and reliability of our data collection process.”

4. Explain your understanding of ethical considerations for conducting research.

Research projects involve gathering data from human subjects, and it’s important to ensure that their privacy and rights are respected. Interviewers want to know that you’re aware of the ethical considerations related to research, such as informed consent, confidentiality, and data security. You should be prepared to discuss your understanding of these issues and any steps you’ve taken to ensure that ethical standards are met.

Start by talking about the ethical principles that guide research, such as respect for persons, beneficence, and justice. Explain how you ensure that participants understand their rights and give informed consent before participating in a study. Discuss any protocols or procedures you’ve put in place to protect the confidentiality of participants’ data and ensure it is used only for the purpose of the research. Finally, mention any additional steps you take to ensure that research projects are conducted ethically, such as providing debriefing sessions or taking extra precautions with vulnerable populations.

Example: “I understand that conducting research involves a great deal of responsibility, and my goal is to ensure that all participants are treated with respect. I always make sure that potential volunteers have the opportunity to give informed consent before taking part in any study. Additionally, I take steps to protect their privacy by ensuring that all data is securely stored and only used for the purpose of the research project. To further safeguard against ethical issues, I provide debriefing sessions after each study to discuss the results and answer any questions they may have.”

5. Are you familiar with any software programs used for collecting, analyzing, and reporting on research data?

Research coordinators often have to use software programs to collect, analyze, and report on data. An interviewer wants to know that you are familiar with the software programs you will be using and the research techniques you will be applying. By asking this question, the interviewer can get a sense of your experience and expertise in the field.

When answering this question, be sure to mention any software programs you are familiar with and how you have used them in the past. You can also explain what research techniques you are most comfortable working with and why. Additionally, highlight any special skills or experience you may have that would make you an ideal candidate for the position.

Example: “I am familiar with a variety of software programs used for collecting, analyzing, and reporting on research data. For example, I have experience using SPSS to analyze survey results and generate reports. Additionally, I am comfortable working with qualitative methods such as interviews and focus groups, and I understand the importance of accurate record-keeping when it comes to research. My background in psychology has given me an understanding of how to effectively interpret data and draw meaningful conclusions from the results.”

6. What strategies do you use to recruit participants for research studies?

Recruiting participants for a research study can be a difficult and time-consuming process. The interviewer wants to know that you have a methodical approach to recruiting participants, as well as an understanding of how to reach out to and engage potential participants. They’re also looking for evidence that you can work with limited resources and adjust your strategies to meet any challenges that arise.

To answer this question, you should explain the strategies that you have used in the past to recruit participants. For example, you could talk about how you have used online and offline advertising, as well as word-of-mouth marketing, to reach potential participants. You can also discuss any experience you have with using social media platforms to promote research studies, or how you’ve collaborated with other organizations to increase visibility for your projects. Additionally, it’s important to mention any creative solutions you’ve come up with when faced with recruitment challenges.

Example: “When recruiting participants for research studies, I use a combination of online and offline strategies. I’ve found that advertising on social media platforms is an effective way to reach potential participants, as well as leveraging my professional network to spread the word about projects. I also have experience creating and implementing targeted campaigns to increase visibility in specific communities. When faced with recruitment challenges, I develop creative solutions such as partnering with other organizations or developing incentives for participants. These strategies have helped me successfully recruit participants for several research studies in the past.”

7. How do you handle difficult conversations with participants or stakeholders?

Being a research coordinator can be a difficult job. You’ll need to juggle the expectations of participants, stakeholders, and the research team all at once. You’ll also need to handle difficult conversations with participants or stakeholders as part of your job. This question is designed to gauge how you handle tough conversations, and whether or not you can keep the focus on the research objectives and the participants’ needs.

Talk about your experience in dealing with difficult conversations. Show that you understand the importance of being a good listener and an effective communicator when it comes to tough conversations. Explain how you can remain calm and professional in the face of challenging questions or situations. Talk about strategies you use to ensure everyone feels heard and respected, such as summarizing what has been discussed and asking clarifying questions. Finally, emphasize your commitment to finding solutions that work for all parties involved.

Example: “I understand the importance of having difficult conversations with participants and stakeholders in a research setting. I’ve developed strategies to ensure that everyone feels heard and respected, such as summarizing what has been discussed, asking clarifying questions, and actively listening to their concerns. I also make sure to remain calm and professional throughout the conversation, so we can focus on finding solutions that work for all parties involved.”

8. Describe a time when you had to troubleshoot an issue during a research study.

Research coordinators often juggle multiple studies at any given time, and they will inevitably run into unexpected problems. This question is designed to gauge your problem-solving skills and how you handle challenging situations. The interviewer will want to know how you identified the issue, how you communicated with stakeholders, and what the ultimate resolution was.

Start by describing the issue you faced. Then, explain how you identified it and what steps you took to troubleshoot it. Describe any research or data analysis that you conducted in order to come up with a solution. Finally, talk about how you communicated your findings to stakeholders and how they responded. Make sure to emphasize the positive outcome of your efforts and how it helped move the study forward.

Example: “I was working on a research study for a pharmaceutical company last year, and we encountered an issue with the data we were collecting. I quickly identified the problem and conducted a thorough analysis to determine the root cause. After I presented my findings to the project team, we decided to adjust our methodology and I worked with the data team to ensure that we had the right data points going forward. In the end, we were able to successfully complete the study on time and within budget, which was a great result for everyone involved.”

9. What methods do you use to ensure that all research protocols are followed correctly?

Research coordinators are responsible for ensuring that all research protocols are followed correctly and that data is collected, stored, and analyzed correctly. This question helps interviewers understand how you manage and track research protocols, and how you ensure accuracy and consistency throughout the research process.

Start by talking about the methods you use to ensure protocols are followed correctly. This can include creating a checklist of tasks that need to be completed, developing standard operating procedures (SOPs), and setting up systems for tracking results. You should also talk about how you collaborate with other members of the research team to ensure accuracy and consistency in data collection and analysis. Finally, discuss any methods you have used to troubleshoot issues related to protocol compliance.

Example: “I use a variety of methods to ensure that all research protocols are followed correctly. I create a checklist of tasks that need to be completed and establish standard operating procedures (SOPs) to ensure accuracy and consistency throughout the research process. I also collaborate with other members of the research team to ensure that everyone is on the same page and that data is collected and analyzed correctly. Additionally, I have developed systems for tracking results and I use these to troubleshoot any issues related to protocol compliance.”

10. How do you stay informed about new developments in the field of research?

It’s important for research coordinators to stay up to date on the latest advances in their field. This question gives the interviewer an opportunity to see how you take it upon yourself to stay informed and how you use the information you’ve gathered to improve the research process. It also shows them that you’re passionate about what you do and that you’re willing to go the extra mile to ensure the success of the project.

This question is designed to assess your knowledge of the industry and how up-to-date you are on new developments. The best way to answer this question is to demonstrate that you actively seek out opportunities to stay informed, such as attending conferences or seminars, subscribing to relevant journals or newsletters, and following experts in the field on social media. Additionally, if you have any specific strategies for staying informed, such as setting aside time each day to read articles related to research, be sure to mention them.

Example: “I make it a priority to stay informed about new developments in the field of research. I attend conferences and seminars whenever I can to stay abreast of the latest research findings, and I subscribe to several journals and newsletters to keep up with the latest trends. I also follow experts in the field on social media, and I make sure to set aside time each day to read articles related to research. Additionally, I often share interesting findings with my colleagues to help us all stay informed.”

11. What challenges have you faced while managing research projects?

Coordinating research projects involves juggling many different moving parts. It’s important that potential hires are able to demonstrate that they can handle a variety of challenges, from managing conflicting schedules to ensuring proper data collection and analysis. This question will help the interviewer get an idea of the applicant’s ability to handle complex projects.

Talk about specific challenges you have faced while managing research projects in the past. Think of examples where you had to think quickly on your feet, such as when a participant was late or data wasn’t collected correctly. You can also talk about how you handled difficult conversations with stakeholders, such as when you had to explain why a project timeline had been extended or why certain data points were not included in the analysis. Be sure to focus on the solutions you implemented and the results that followed.

Example: “In my role as a research coordinator for ABC Company, I have faced a wide range of challenges while managing research projects. For example, I had to quickly adapt when a participant did not show up for a scheduled data collection session. I called the participant and was able to reschedule the session for a later date. I also had to modify the timeline for a project when a key stakeholder unexpectedly changed their availability. Through careful negotiation, I was able to adjust the timeline without compromising the quality of the project. I also had to explain why certain data points were not included in the analysis to a group of stakeholders, which required me to be diplomatic while also standing firm in my decisions. I was able to successfully address all of these challenges and the project was completed on time and within budget.”

12. How do you prioritize tasks when working on multiple research studies at once?

Research projects can involve multiple studies, tasks, and deadlines, which means you’ll need to be able to prioritize your time and resources efficiently. This question is an opportunity to show your organizational and problem-solving skills, as well as how you handle stress and competing demands.

You can start by describing how you prioritize tasks and explain the criteria you use to determine which tasks are most important. For example, if a task has an impending deadline, it would take precedence over other tasks with less urgency. Additionally, you could talk about how you break down complex projects into smaller tasks that are easier to manage. Finally, you should mention any strategies or tools that you’ve used to stay organized and on top of your work.

Example: “When I’m working on multiple research studies at once, my first priority is to make sure I’m aware of all the deadlines and prioritize tasks accordingly. I use a project management system to break down tasks into smaller, more manageable chunks and assign them to different members of the team so that we can all work together efficiently. This system helps us stay on track and ensures that nothing slips through the cracks. I also like to take regular breaks throughout the day, which helps me stay focused and motivated.”

13. What strategies do you use to communicate complex research findings to non-experts?

Research coordinators need to be able to communicate complex research findings in a way that’s accessible to non-experts. This could include presenting data in a way that’s visually understandable, breaking down complex ideas into smaller parts, or finding ways to make the research more relatable to the audience. Interviewers might ask this question to gauge your ability to explain difficult concepts to a variety of people.

You can answer this question by talking about strategies you’ve used in the past, such as using visuals to explain concepts or providing examples that are easy for people to understand. You should also mention any experience you have with translating complex research findings into layman’s terms. Finally, emphasize your ability to adjust communication styles depending on the audience and how comfortable you feel communicating with different groups of people.

Example: “I always start by understanding who my audience is and what their level of understanding of the research is. Then I tailor my communication style and the visuals I use to make sure they can easily understand the findings. I’ve found that creating infographics and charts can be a great way to explain complex data in a way that’s easy to understand. I also like to provide examples and analogies that can help people who don’t have a scientific background to better comprehend the research. Finally, I’m comfortable using different communication styles depending on the audience, from formal presentations to informal conversations.”

14. Do you have experience writing grant proposals?

Research coordinators are responsible for managing and helping to carry out research projects. This often requires writing grant proposals and reports to secure funding for projects. So it’s important that a research coordinator has experience in this area. Answering this question will help the interviewer determine if you have the necessary skills and experience to be successful in the role.

To answer this question, you should provide an example of a grant proposal that you have written. Talk about the process and steps you took to write it, as well as how successful it was in securing funding for the project. You can also talk about any research experience or qualifications that make you uniquely qualified to write effective grant proposals.

Example: “Yes, I have extensive experience writing grant proposals. I have written several successful proposals for research projects that I have managed. For example, I wrote a successful grant proposal for a research project studying the effects of climate change on the Arctic ecosystem. The proposal was successful in securing $250,000 in funding for the project. I also have a Master’s degree in Applied Research, which has given me an in-depth understanding of the process of writing and submitting grant proposals.”

15. How do you ensure that research results are disseminated effectively?

Research coordinators are responsible for ensuring that research results are communicated to the appropriate stakeholders in a timely and effective manner. By asking this question, the interviewer is trying to gauge your understanding of the importance of communicating research results and your ability to effectively manage the dissemination process.

To answer this question, you should discuss the steps that you take to ensure that research results are disseminated effectively. This can include outlining your process for identifying key stakeholders and ensuring that they receive timely updates on any relevant research findings; discussing how you work with other departments or teams within the organization to ensure that everyone is aware of the latest research developments; and providing examples of how you have successfully managed the dissemination process in the past.

Example: “To ensure that research results are disseminated effectively, I always start by creating an up-to-date list of all relevant stakeholders and determining the best method for communicating research results to each of them. I then work closely with other departments and teams within the organization to ensure that everyone is aware of the latest research developments. Finally, I use my project management skills to ensure that research results are disseminated in a timely and organized manner. For example, I recently managed a project that required me to ensure that the research results were disseminated to the appropriate stakeholders within a two-week time frame. I was able to successfully meet this deadline by creating a detailed schedule, assigning tasks to team members, and providing regular updates on the progress of the project.”

16. What techniques do you use to motivate team members to complete their work on time?

Research coordinators are responsible for leading teams of research assistants and interns in completing projects on time and within budget. Showing an interviewer that you understand the importance of motivating your team is key to getting the job. By asking this question, they want to know what strategies you use to ensure that your team is working efficiently and effectively.

To answer this question, you should talk about the strategies that you have used in the past to keep your team motivated. Examples of techniques could include setting clear goals and expectations for each project, providing incentives or rewards for meeting deadlines, offering regular feedback on performance, and recognizing individual contributions. You can also mention any methods you use to measure progress and ensure that work is completed on time. Finally, emphasize how important it is to create a positive team environment where everyone feels valued and respected.

Example: “I believe that motivation starts with clear expectations and goals. I make sure that my team understands the timeline for each project and the expected outcome. I also provide regular feedback on performance and recognize individual contributions. I also like to offer incentives or rewards for meeting deadlines and goals. I also use progress tracking tools to measure progress and ensure that work is completed on time. Lastly, I focus on creating a positive team environment where everyone is respected and feels valued.”

17. How do you handle conflicts between different stakeholders involved in a research project?

Research projects often involve a lot of different stakeholders, from researchers to funders to participants. It’s important for a research coordinator to be able to manage these relationships and resolve any conflicts that arise. The interviewer wants to know that you can handle challenging situations, find compromises, and keep the project moving forward.

You should come prepared with a few examples of how you have handled conflicts in the past. Talk about the steps you took to identify the root cause of the conflict, ways that you worked to resolve it, and any creative solutions you came up with. Be sure to emphasize your communication skills, ability to listen to all sides, and willingness to find a solution that works for everyone involved.

Example: “I’ve had to manage conflicts between stakeholders in a few of my research projects. In one instance, there was a disagreement between the researchers and the funders about the scope of the project. To resolve the conflict, I took the time to sit down with both sides and listen to their concerns. I then worked with them to come up with a compromise that allowed the project to move forward while still meeting the needs of both parties. I also worked to improve communication between the stakeholders by setting up regular meetings and ensuring that everyone had a clear understanding of the goals and expectations for the project.”

18. What strategies do you use to maintain participant confidentiality?

Research coordinators are responsible for collecting, organizing, and analyzing data, and confidentiality is a critical factor in any research project. Interviewers will want to know that you understand the importance of protecting participant data and that you have the experience and strategies needed to ensure that all data remains private and secure.

Begin by discussing any relevant experience you have with data protection, such as working in a secure environment or handling sensitive information. Then, explain the strategies you use to maintain participant confidentiality, such as using encrypted files and passwords, limiting access to certain areas of the research project, and utilizing two-factor authentication. Finally, discuss how you ensure that all participants are aware of their rights and responsibilities when it comes to protecting confidential data.

Example: “I have extensive experience with data protection, having worked in a secure environment for several years. To maintain participant confidentiality, I use several strategies. I make sure to use encrypted files and passwords to protect sensitive information. I also limit access to certain areas of the research project by assigning permissions to specific individuals. Additionally, I utilize two-factor authentication whenever possible. Finally, I ensure that all participants are aware of their rights and responsibilities in terms of protecting confidential data, and I make sure that they understand the consequences of any breach in security.”

19. How do you evaluate the success of a research project?

Research coordinators are tasked with managing research projects from start to finish. Part of that job involves understanding how to evaluate the success of the project. This question allows the interviewer to determine if the candidate has the skills and knowledge necessary to assess the impact of the research they will coordinate. The interviewer will be looking for evidence of the candidate’s ability to think critically and objectively evaluate the success of a project.

A good answer to this question should include the candidate’s ability to analyze data, identify trends, and draw conclusions. The candidate can also demonstrate their understanding of the research objectives and how they will measure success against those objectives. Additionally, they should be able to explain how they would use feedback from stakeholders to assess the project’s success. Ultimately, the interviewer wants to know that the candidate has a clear understanding of how to evaluate the success of a research project.

Example: “In my experience, the success of a research project is evaluated by analyzing data, identifying trends, and drawing conclusions. I am also able to evaluate the success of a project by understanding the research objectives and measuring the results against those objectives. I take feedback from stakeholders into account and use it to make adjustments as needed. Ultimately, I strive to ensure that the research project is successful and meets the goals and objectives that were set out at the start of the project.”

20. What would you do if a research study was not producing the expected results?

Research coordinators are responsible for managing research studies and ensuring that the results are accurate and reliable. If a study is not producing the expected results, it can be difficult to troubleshoot and determine the source of the issue. This question allows the interviewer to assess your problem-solving skills and how you handle unexpected circumstances.

You should demonstrate that you are capable of troubleshooting and identify potential sources for the unexpected results. Explain how you would go about analyzing data, reviewing protocols, and consulting with experts to determine the cause of the issue. Show that you understand the importance of accuracy and reliability in research studies and that you have the skills necessary to ensure the validity of the study’s results.

Example: “If a research study was not producing the expected results, I would start by closely reviewing the protocols and data. I would look for any discrepancies or inconsistencies that could have caused the unexpected results. I would also consult with experts in the field to get their input and insights into the issue. Finally, I would use my problem-solving skills to brainstorm solutions and develop an action plan for how to move forward. I understand the importance of accuracy and reliability in research studies and I am confident in my ability to identify and resolve any issues that may arise.”

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IMAGES

Action Research Plan In Apa
Research Action Plan Examples
FREE 10+ Research Action Plan Samples in PDF
Action Research Plan
(DOC) Action plan for action research
Research Action Plan

VIDEO

Climate Action Plan
X'Plan un succès collectif en BFC
Anticipate Feedback: Turn Criticism into Your Ally #irfannawaz #phd #research #tips
Participatory Research: Involving Women in Project Development
Reference Rockstar: Master Citations and Conquer Your Proposal #irfannawaz #research #phd
How to do user research without researchers

COMMENTS

PDF Developing a Research Action Plan for Your Organization
Introduction. The Action Plan is a guide to planning for change, and it describes: . A clear picture of where you are currently, where you are going, and where you want to be in 3-5 years. How you are going to get there. Who and what are involved. Elements of the Action Plan. Goal(s) Objectives.
(DOC) Action plan for action research
To submit all action research to the Division's Research Coordinator. Collect and record all the data needed. Submit all action research to the Division's Research Coordinator. Master Teachers Researchers Principal Master Teachers Researchers First week of Decem-ber Second week of Decem-ber Hardcopy of Action Research Results were tabulated ...
Research Action Plan.docx
Designation of School Research Coordinator in Schools The Governance of Basic Education Act of 2001 (RA 9155) mandates that the Department of Education (DepEd) enact policies and mechanisms through which the delivery of quality basic education may be continuously improved. Chapter I, Section 7 (5) includes among the responsibilities of DepEd across all governance levels the undertaking of ...
Action Plan Research 2021 2022
SCHOOL ACTION PLAN in SCHOOL RESEARCH SY 2021-OBJECTIVES/ TARGETS STRATEGIES/ ACTIVITIES TIME FRAME PERSON INVOLVED ... Teachers, Research Coordinator. Research Capsule. School Based Research Proposal. To seek guidance in managing research initiatives in school and district. Seminar on Capability Development on Research Management. Sponsored by ...
Guidelines on the Functions of the School Research ...
Attached are the Guidelines on the Functions of the School Research Committee (SRC) Members that specifies the ten (10) salient points of the SRC members' functions based on the provisions of DepEd Order No. 16, S. 2017 otherwise known as the "Research Management Guidelines or RMG".. This will serve as a guide in the initial evaluation of action researches submitted by teacher ...
Research Action Plan
You may also see quality plan examples & samples. We will be discussing below the importance of research action plans to each sector that was mentioned. 1. Business. This is where research action plans are constantly created and used. Business entities, specifically companies, conduct research for various reasons.
Qualities of a Good Research Coordinator 101
Clinical research coordinators (CRCs) help investigators conduct clinical trials, from basic preventative care to curing diseases and everything in between. Clinical trials are essential for developing and delivering evidence-based care and for testing new interventions. Whether it is testing the use of a new medication or a surgical procedure ...
Designation of School Research Coordinator in Schools
SCHOOL RESEARCH COORDINATOR FUNCTIONS. Research coordinators shall perform the following functions: a. develop initiatives in improving the culture of research. b. monitor the progress of research activities. c. maintain and prepare updated records of research and research activities. d. attend research-related training. Share with your friends!
13 SMART Goals Examples for Research Coordinators
I will also shadow a senior research coordinator for two projects to gain hands-on experience managing research projects." Specific: You plan to elevate your project management skills for 6 months. Measurable: Gauge progress by checking off the listed action items: completing the course, reading the books, and shadowing a senior research ...
PDF Corrective and Preventive Actions (CAPA) Plans
Risk Response Action Plan Document Effective Corrective and Preventative Action Plans Quality Assurance Review Program. 5/25/2018 3 QUALITY ASSURANCE REVIEW ... attention: his consent document stated he wouldn't have to pay for anything. The lead research coordinator discovered that the original, outdated consent document presented erroneous ...
PDF Job Description: Research Coordinator
POSITION PURPOSE: Coordinates and administers research study associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, as appropriate, and serves as principle administrative liaison for the project.
What is an Action Plan & How to Write One [With Examples]
An action plan is a detailed outline that breaks down the steps necessary to achieve a specific goal. Here are the typical components of an action plan. 1. Objective or Goal. The cornerstone of your action plan is the objective or goal. This should be a clear and concise statement outlining the desired outcome or result.
PDF Strategic Plan for Research
Updates to the Plan. The NIMH Strategic Plan for Research is a living document, which means it is updated regularly to keep pace with ever-evolving scientific approaches and research priorities that can lead to new discovery. The most recent update was published in July 2021.
Action Plan in Research
Action Plan in Research - Free download as Excel Spreadsheet (.xls / .xlsx), PDF File (.pdf), Text File (.txt) or view presentation slides online. An action plan is a document that lists what steps must be taken in order to achieve a specific goal
Career Progression in Clinical Research: Transitioning from a ...
A roadmap in the form of a checklist is provided to help make the transition from research coordinator to clinical research associate (CRA) a smooth one. ... monitors are constantly in contact with clinical research sites to follow up on action items from monitoring visits or to answer protocol specific questions the site coordinators may have ...
Resolving and Preventing Repetitive Problems in Clinical Trials
A corrective and preventive action (CAPA) plan is a series of actions taken to resolve a compliance issue, and most importantly, to prevent further recurrence (Table 2). A CAPA plan will focus on the immediate noncompliance and the broader scope of the problem. It involves investigating and understanding the issue, correcting the issue, and ...
PDF Strategic Plan for Research
The data presented in the original research strategic plan encompassed fiscal years 2009 to 2013. As a contextual guide for creating the research plan, ERPC members relied upon the 2012-2017 University Strategic Plan. In particular, three goals in the 2012-2017 Strategic Plan (below) and the
How do Clinical Research Coordinators learn Good Clinical Practice? A
The duration and richness of experience as a Clinical Research Coordinator were the strongest predictors of GCP knowledge; a finding consistent with our exploratory qualitative interview results. Our findings suggest formal online and face-to-face training has a minimal influence on GCP knowledge. The type of training - whether online or face ...
District Research Action Plan
District Research Action Plan - Free download as Word Doc (.doc / .docx), PDF File (.pdf), Text File (.txt) or read online for free. Action Research Plan for North Glan District
What does a Research Coordinator do? Role & Responsibilities
Research coordinators must administer the trial while following competent clinical practice guidelines. They will study their subjects and ensure the clinical trial is successfully operated. They assist investigators in the screening and review of potential participants for their eligibility; they maintain report forms, charts, and documentation.
Sample School Action Plan in ICT for Teachers and Subject Coordinators
School Action Plan in ICT for Teachers and Subject Coordinators. An action plan is a detailed plan outlining actions needed to reach one or more goals. Alternatively, businessdictionary.com defines an action plan as a "sequence of steps that must be taken, or activities that must be performed well, for a strategy to succeed". - Wikipedia. An ...
20 Research Coordinator Interview Questions and Answers
2. Describe a time when you had to manage multiple projects simultaneously. Research coordinators often have to juggle multiple tasks, projects, and deadlines at once. This question is designed to determine if you have the organizational and multitasking skills necessary to successfully manage the job.
Full article: Applying Community-Based Participatory Research
This study serves as an application of CBPR. In alignment with the WHO Global Strategy on Oral Health and Oral Health Action Plan, this project explores interconnected determinants of oral health in La Casona through stakeholder-driven research. Assessing both protective and risk factors is important in understanding community oral health.