The Anatomy of a Great Clinical Research Coordinator

Clinical Researcher—August 2018 (Volume 32, Issue 7)

SPECIAL FEATURE

Cyenthia Willis, RN, BSN, CCRP; Karen Bratcher, MSN, RN, CNL, CCRC; Tawni Kenworthy-Heinige, BS, EMT-I, CPT, CCRP; Conor McBurney, MPH; Aliya Asghar, MPH, CCRC; Danielle Beck, MPH, CCRC; Debra L. Condon, MSN, RN, CCRP; Grant D. Huang, MPH, PhD

 

Clinical trials are critical for developing and delivering evidence-based care. The successes of these research studies often rely on clinical research coordinators (CRCs), who carry out many of the key clinical, administrative, and regulatory compliance responsibilities.

The demand for good CRCs is high, especially given recent emphasis on quality in clinical trials.{1} While several professional research groups offer training and/or certification for CRCs, there are other approaches that can assist them in reaching a higher performance level. The following provides practical considerations based on experiences conducting such studies within the Veterans Health Administration, the nation’s largest integrated healthcare system.{2}

Part I: Setting the Stage

Though principal investigators (PIs) are responsible for all clinical trial activities from a regulatory standpoint,{3} it is essential that CRCs and PIs collaborate together to ensure that studies are conducted in accordance with both the protocol and the tenets of Good Clinical Practice.

The success of clinical trials relies heavily upon CRCs’ abilities to effectively manage day-to-day study tasks. This journey begins by successfully selecting an ideal CRC. While this may be challenging, there are specific methods that can help to simplify the process and increase the likelihood of selecting the best candidates. These include developing an applicable position description, identifying and screening the appropriate pool of applicants with the desired qualifications, and implementing a well-planned, structured interview process.

Employers or supervisors should collaborate with their Human Resource departments to create well-design position descriptions, keeping in mind the needs of specific types of studies and therapeutic areas, including required skills, education, certifications, and experience. It is optimal to have a panel of at least three interviewers with diverse experience in human subjects’ research and managing clinical trials. The interview panel should review resumes and highlight requisite characteristics desired, thereby increasing the likelihood of identifying the most qualified CRC applicants to interview.

During the interview, the panelists should ask the applicant a variety of structured open-ended, hypothetical (or situational), and behavioral questions to ascertain research-related experience. A great CRC candidate will provide responses that demonstrate effective communication skills and give examples of problem-solving, initiative, efficient time management, collaboration, and prioritization of tasks.

It may be difficult to identify all the qualities of a good CRC; however, there are traits that distinguish a good CRC from a great CRC, which we describe as the “Five C’s” (see Figure 1).

 

Figure 1: The “Five C’s” of a Good CRC

COORDINATION

Time to study startup
Navigate strict eligibility criteria
Patient travel and other issues
Data monitoring and reporting
Promotion/awareness of clinical trials

CONNECTION

Rapport
Accountability
Transparency
Empowerment

COMMITMENT

Willingness to be challenged
Seeks ways to overcome obstacles
Exceeds minimal expectations

COMMUNICATION

Ensure participant understanding
Develop synergistic relationships

COLLABORATION

Develop partnerships
Become a clinical research resource

 

Coordination

Over the lifetime of a clinical trial, an experienced CRC is responsible for coordinating and implementing many study-related activities. A key attribute of a successful study is the organizational capabilities of its CRC. Serious complications can result when records (e.g., regulatory binders) and data management are disorganized. These complications can result in institutional review board (IRB) sanctions, funding withdrawal, probation, administrative suspension or termination, and unusable data.

Anticipating problems can help prevent potential punitive actions. It is therefore imperative that a CRC efficiently coordinates the crucial activities of a study, such as initiating timely start-up, navigating strict eligibility criteria, minimizing participant travel and/or financial burden, ensuring data monitoring accuracy, and having continued awareness of competing clinical trials.

Study Start-Up: There are a variety reasons why a study may fail to launch in a timely manner. The CRC is typically responsible for facilitating study start-up activities to ensure that a study begins within the projected timeframe. A great CRC will develop and implement organizational techniques, such as a checklist to prioritize and complete tasks. These tasks include engaging stakeholders, creating budget projections, identifying study staff, determining space needs, and ensuring timely submission of documents.

Appropriate time management during start-up activities can decrease delays in recruitment, help the site meet its study goals, and increase overall study efficiency. Timely start-up also avoids fiscal pitfalls that may have a negative impact on sponsors.

Navigate Strict Eligibility Criteria: Every study is unique in terms of its inclusion/exclusion criteria. The stricter the eligibility of a research study, the more difficult it can be to find appropriate participants. A great CRC will be well organized and will establish a quick mental checklist using a methodical approach.

To enhance navigating eligibility, a great CRC might create a laminated quick-reference pocket guide for easy elimination of ineligible participants during the screening process. For example, if two exclusions are AIC < 5.7 % and participants < 40 years old, then the quickest method to determine if the participant is ineligible would be to simply look at the age first. If a prospective participant is more than 40 years old, then the CRC can quickly move to the next potential participant to screen. Once the CRC has determined a participant meets all criteria, then he/she can proceed per protocol.

Minimize Participation Burden: Historically, participant travel, financial hardships, and other logistical concerns have been barriers to recruitment into clinical trials.{4} Demographic disparities exist among prospective research subjects, limiting participation to those who meet the eligibility criteria. A well-versed CRC understands the importance for participants to be adherent to their study appointments. A great CRC will seek alternative means of transportation, visit locations, and investigate reimbursement options for the participants to help offset potential travel and financial burden and to better facilitate logistical issues that might otherwise disrupt study participation.

Ensure Data Monitoring Accuracy: The CRC collects and inputs data from many sources; therefore, data must be accurate, reliable, and verifiable. One of the crucial data points of a clinical trial is reporting adverse events (AEs), serious adverse events (SAEs), and safety issues in a timely manner. A great CRC will have methods in place to help alert and determine if a participant has experienced AEs/SAEs. A well-organized CRC may create electronic medical record alerts (e.g., alerting that a participant is hospitalized or has abnormal lab values) or may develop a source checklist to ensure all study activities and AEs/SAEs have been captured during study visits with the participant.

Clinical Trials Awareness: Having a clear understanding of other competitive trials allows the CRC to better navigate or facilitate recruitment strategies. A great CRC will be aware of competing clinical trials within the same geographical and therapeutic areas involving the same target population.

In addition to being knowledgeable of other projects (current or upcoming), a great CRC should be a resource for individuals interested in opportunities for participating in clinical trials. Former research participants often inquire about other projects for which they may qualify—especially studies that fall within a health condition of interest

Connection

A CRC is often the “face” of the study for participants. First impressions matter, and can develop into relationships lasting the duration of each trial; this fact alone can increase patient retention rates.

In addition to recruiting subjects, one of the primary responsibilities of a CRC is to help them navigate the various research entities involved in studies (e.g., labs, pharmacy, imaging, etc.). Therefore, the CRC must create a relationship of trust and dependability as a research case manager for the participant. A great CRC adheres to the RATE Principle, which explores the ideas of Rapport, Accountability, Transparency, and Empowerment (see Figure 2).

 

Figure 2: The RATE Principle

The RATE Principle is a creation of the Network of Dedicated Enrollment Sites (NODES), a core component of the Veterans Administration (VA) Cooperative Studies Program (CSP).

 

Rapport: It is advantageous for CRCs to build rapport with potential participants who express interest in studies. Addressing participant questions, translating study jargon, and achieving a mutual understanding about the purpose of the study before proceeding with the informed consent can establish a solid relationship foundation. The development of this initial relationship strengthens participants’ likelihood for adherence and retention throughout a study’s lifecycle.

A great CRC personalizes each participant’s encounter with a positive interaction—providing additional education and creating a “safe zone”, while maintaining professional boundaries. This safe zone creates an atmosphere in which participants can share their personal or health information relative to studies, communicate concerns about being research subjects, and discuss any other barriers that may prohibit their participation. As CRCs develop a better understanding of participants’ needs, they able to anticipate patient engagement and proactively assist them with navigating the study process. By establishing a strong rapport with participants, CRCs become a trusted point-of-contact for studies.

Accountability: The PI is ultimately accountable for the overall conduct of a study, while the CRC is generally responsible for day-to-day operations. A good CRC supports the PI in ensuring the safety and well-being of the study participant, and is often the link among the PI, study participants, other study team members (e.g., sub-investigators, research assistants, etc.), the IRB, study sponsor, and other governing bodies.

The CRC customarily oversees the proper execution of, and adherence to, an approved protocol by ensuring accurate and timely study data collection, and by maintaining the highest standards of regulatory compliance. The CRC understands the significance of the consenting process and emphasizes the importance of participants’ comprehension of the study objectives and their commitment to study procedures. A great CRC is knowledgeable about the research infrastructure, has an acute awareness of team communication and cohesiveness, and strives to keep stakeholders informed of new study developments.

Transparency: Being transparent about a study’s intent with participants is crucial. When considering infamous instances of unethical research (e.g., Tuskegee Syphilis Study), participants may be resistant and fearful of joining a clinical trial.{5} An ethical CRC is honest and without bias, and answers participants’ questions openly, sincerely, and directly. The CRC must provide full disclosure of study-related resources, safety issues, costs/benefits (e.g., emotional, physical, financial), and research design and group randomization details, as well as potential outcomes of the study. A great CRC will emphasize participants’ rights, how privacy and confidentiality are maintained, and the fact that research is voluntary, and ensure that participants know that they may withdrawal at any time without loss of healthcare benefits. Ensuring full understanding of the study will enhance participants’ trust regarding their safety and well-being.

Empowerment: Once rapport, accountability, and transparency have been established, facilitating participant empowerment is a fundamental task for a CRC. Empowerment occurs with shared decision-making, self-management, and enhanced health literacy and knowledge. Empowering participants can strengthen their sense of control and commitment, as well as increase their levels of satisfaction while participating in studies.

Widely discussed in healthcare is placing participants at the center of care—ensuring they are major contributors in the decision-making process. A great CRC ensures participants are empowered with the information necessary to make informed decisions about study participation. The CRC should discuss in depth the side effects of study medications and/or procedures to enhance the participants’ health literacy and knowledge. Empowerment and autonomy help participants to develop and practice self-managing skills (e.g., observing medication schedules, maintaining diaries, attending study visits), thereby improving study adherence and outcomes.

Commitment

When CRCs find value in their organizations and are committed to research projects, the projects will have better chances of accomplishing their end goals. Studies have shown that organizational performance is highly related to work commitment.{6} Additionally, a committed employee is adaptable to accommodate the needs of the job.{7} A great CRC demonstrates the attributes of commitment in terms of being willing to be challenged, seeking ways to overcome obstacles, and exceeding minimal expectations.

Willingness to be Challenged: Great CRCs are not intimidated by study challenges beyond their expertise or comfort levels; they are eager to expand their skill sets through training, observation, mentorship, and performance.

Seeking Ways to Overcome Obstacles: Even the best-planned research project will encounter unexpected obstacles. A great CRC seeks ways to contribute innovative ideas, and learns from these barriers to create and share best practices for the study.

Exceeds Minimal Expectations: A great CRC strives to apply flexibility and adaptability to the needs of the study, which may include undertaking additional tasks, adjusting competing priorities, extending work schedules, or attending educational opportunities outside the work setting.

Communication

The CRC must communicate with participants, PIs, sponsors, key stakeholders, ancillaries, regulatory agents, and coworkers on an ongoing basis. A great CRC possesses excellent verbal and written communication skills.

Ensure Participant Understanding: When communicating with participants, the CRC should be able to explain a complex research protocol at the patient’s level of understanding. A great CRC will ensure this understanding, as demonstrated by the participant’s ability to verbalize the purpose of the study and the procedures involved.

Develop Synergistic Relationships: Communication is an essential foundation of team building. A CRC must also be able to concisely communicate and respond quickly with a variety of regulatory boards and oversight bodies. Consistent communication with these entities will enhance transparency and develop synergistic relationships. A great CRC will use a variety of communication methods with peers and ancillaries to facilitate the daily operations of a clinical trial.

Collaboration

While serving as an integral part of a network of researchers, the CRC often works independently or as part of a small team. A great CRC is self-motivated, autonomous, and assumes more of a leadership role in building collaborative relationships.

Develop Partnerships: The study team often relies upon ancillary entities to provide services that fulfill the study protocol. A great CRC will recognize and explore necessary resources to facilitate an efficient trial. Enhancing these resources are often done by partnering with clinical departments (e.g., diagnostic labs, pharmacy, outpatient/community clinics, etc.), medical disciplines (e.g., primary care, occupational health, mental health, etc.), and supportive services (e.g., public affairs, information technology, etc.) by establishing contacts to foster successful collaboration and communication.

Become a Clinical Research Resource: Through the dynamics of collaboration, a great CRC will seek ways to close communication gaps, empower team members, provide mentorship, and assume a preceptor role, thereby becoming an invaluable resource in clinical research.

Part II: Behind the Scenes

While the “Five C’s” delineate the differences between a good and a great CRC, the question that presents is how one may transition from “good” to “great”? We believe that there are five key elements that prepare a good CRC to becoming a great one. We describe these as the “Five P’s” to Propagate a Great Clinical Research Coordinator (see Figure 3).

 

Figure 3: The “Five P’s” to Propagating a Great Clinical Research Coordinator

The “Five P’s” Principle is a creation of the Network of Dedicated Enrollment Sites (NODES), a core component of the Veterans Administration (VA) Cooperative Studies Program (CSP).

 

Professional Development

A CRC will progress from novice to expert when exposed to a dedicated support system (e.g., a mentor, a network of coordinators, educational resources, etc.). The opportunity to discuss confusing issues, experiences in problem solving, and sharing best practices can be powerful both professionally and personally.

A great CRC will consistently seek ways to enhance his/her education and knowledge. There are several internal and external resources available to enhance one’s research career; these include clinical research professional organizations and universities that offer continuing education and certifications. Attending applicable, topic-related conferences and webinars is also recommended.

PI Mentorship

The PI can be crucial in propelling a good CRC toward being a great CRC. While it is important that the PI be highly involved in study oversight, micro-managing CRCs could alter their interdependent relationship. Conversely, when a PI allows a CRC to become isolated or siloed without support, he or she may become detached, leading to a lack of accountability or commitment.

Engaged PIs will meet regularly with CRCs at their sites to discuss study status, and will mentor them to enhance their skill levels. This mentorship may include guidance on conducting more clinically based identification of potential study participants, providing clinical support during the patient consent process, explaining the differences between AEs and SAEs, facilitating connections with fellow colleagues, affording training and educational opportunities, and fostering authorship contributions for publications.

Passion for Research

A good CRC has full knowledge of studies at his or her site and the ability to connect with prospective participants; however, a great CRC not only understands the intent of the study, but also promotes the study with passion and enthusiasm. When CRCs are passionate about studies, they portray confidence to proficiently conduct research. The passion of a CRC can lead to increased participant recruitment and retention, improved data compliance and quality, and successful achievement of study goals.

Perseverance

A clinical trial can be a long journey that is filled with frequent challenges. While good CRCs will hold themselves accountable to study expectations, great CRCs will view those milestones as minimal expectations. A great CRC will pursue opportunities for improvement by reaching out to other study teams, sponsors, and/or other entities for ways to enhance study performance. A great CRC also will develop novel methods to maneuver study barriers and navigate resource accessibility throughout the lifecycle of a clinical trial.

Participant Appreciation

A good CRC appreciates research participants, but a great CRC understands their value as volunteers. By developing a deeper respect for participants’ personal sacrifices (e.g., time, expense, commitment), the dynamic between CRCs and participants may become more synergetic, with research visits being viewed as opportunities for connection, rather than as cumbersome or stressful activities.

Within the Department of Veterans Affairs Health Care System, we honor our American Heroes and recognize the sacrifices our Veterans have made for our country. Participating in research is often viewed as another way for them to serve and contribute to the enhancement of healthcare.

Conclusion

Clinical trials are critical for developing and delivering evidence-based care. The success of these research studies often relies on the CRC’s work as a vital member of the clinical research team.

It may be difficult to identify all the qualities of a good CRC; however, there are traits that distinguish a good CRC from a great CRC. A great CRC will demonstrate effective competencies of coordination, connection, commitment, communication, and collaboration—or the “Five C’s.” These attributes, combined with an engaged PI, perseverance, gratitude for research participants, and desire for professional development—or the “Five P’s”—will transform a good CRC into a great one.

A great CRC requires a network of support and encouragement from multiple stakeholders. As one of these stakeholders, the VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) has been instrumental in enriching the characteristics of the “Five C’s” as well as promoting the qualities of the “Five P’s.” This ultimately ensures the success of every CRC managing a clinical trial through education, mentoring, and sharing best practices in clinical research. For more information regarding NODES, please visit https://www.research.va.gov/programs/csp/nodes.cfm.

Disclaimer

The views expressed in this article are those of the authors, and do not necessarily represent the views of the Department of Veterans Affairs or any U.S. government agency.

References

  1. Tenaerts P, Madre L, Archdeacon P, Califf RM. 2014. The Clinical Trials Transformation Initiative: innovation through collaboration. Nat Rev Drug Discov (13)797-8.
  2. Veterans’ Health Administration. https://www.va.gov/health/aboutvha.asp
  3. U.S. Department of Health and Human Services, Food and Drug Administration. 2009. Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects. www.fda.gov/downloads/Drugs/…/Guidances/UCM187772.pdf
  4. Institute of Medicine Forum on Drug Discovery, Development, and Translation. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (D.C.): National Academies Press (U.S.). Challenges in Clinical Research. https://www.ncbi.nlm.nih.gov/books/NBK50888/sited 3/8/2018
  5. Davis A, et al. 2002. The invisible hand in clinical research: the study coordinator’s critical role in human subjects’ protection. J Law Med Ethics 30(3):411-9.
  6. Redmond BF. The Pennsylvania State University. Confluence. Psych 484: Work Attitude and Job Motivation. Part 12: Work and Organizational Commitment. https://wikispaces.psu.edu/display/PSYCH484/12.+Work+and+Organizational+Commitment
  7. Heibutzki R. 2018. What It Means to Be Committed to a Job. http://work.chron.com/means-committed-job-12508.html

Cyenthia Willis, RN, BSN, CCRP, (Cyenthia.Willis@va.gov or cwillis747@yahoo.com) is with the VA North Texas Health Care System in Dallas, Texas.

Karen Bratcher, MSN, RN, CNL, CCRC, is with the VA Palo Alto Healthcare System in Palo Alto, Calif.

Tawni Kenworthy-Heinige, BS, EMT-I, CPT, CCRP, is with the VA Portland Healthcare System in Portland, Ore.

Conor McBurney, MPH, is with the Edward Hines, Jr. VA Hospital in Hines, Ill.

Aliya Asghar, MPH, CCRC, is with the Tibor Rubin VA Medical Center in Long Beach, Calif.

Danielle Beck, MPH, CCRC, is with the VA San Diego Healthcare System in San Diego, Calif.

Debra L. Condon, MSN, RN, CCRP, is with the Minneapolis VA Health Care System in Minneapolis, Minn.

Grant D. Huang, MPH, PhD, is with the Cooperative Studies Program Central Office, VA Office of Research and Development, in Washington, D.C.

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