The Evolving Role of the Clinical Research Coordinator

Clinical Research Coordinators (CRCs) hold a pivotal position and are critical to the success of a clinical trial. These multi-talented team members are often required to be a “Jack-of-All-Trades.” Florence Healthcare describes the CRC as “the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, the taskmaster of the research team.” They manage numerous details of the trial, such as eligibility criteria and adverse event (AE) reporting, while also being responsible for broader communications with trial participants, principal investigators (PIs), trial sponsors, and external labs.

One of the critical responsibilities of a CRC is to maintain essential information about the conduct of the trial. The Good Clinical Practices (GCP) requires much of this information, and noncompliance can result in institutional review board (IRB) sanctions or withdrawal of study funding. 

There are many other pressures on CRCs. As noted in the 2019 Survey by the Italian Group of Clinical Research Coordinators (GIDM) and conducted among their membership, the average number of studies followed by the interviewees was 12.4 actively enrolling trials, and 10.6 trials closed for recruitment. At the time of the interview, only a few respondents could rely on a stable contract, permanent- (21.4%) or fixed-term (12.5%), while most (66.1%) worked through diverse temporary contracts (e.g., freelance, or project-based contracts). 

Varying contractual obligations with sponsors create extra pressures often exacerbated by a continuous flow of protocol changes throughout the trial. These typically set off a flurry of distributing, updating, and redistributing documents. It’s essential to manage and track all these activities under strict study timelines for compliance purposes.

A Myriad of Clinical Trial Technologies

The clinical research coordinator can be viewed as the hub of a wheel with spokes that connect them to stakeholders across the clinical research ecosystem. They are often required to learn and use different data capture, collaboration, and analysis tools.

Understanding the technologies and their strengths and weaknesses becomes a vital part of the role. As more clinical trials move toward hybrid and virtual designs, CRCs must keep up with evolving technologies used within various trials. For example, CRCs can now acquire informed consent from trial participants remotely via telehealth eConsent. CRCs need to be comfortable using the different enabling technologies to ensure compliance and patient safety.

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The Voice of the Clinical Research Coordinator

As clinical trial ecosystems introduce new technologies, CRCs will ensure these new solutions provide adequate support for the trial’s objectives and don’t diminish the team’s abilities to interact with patients or quickly discern issues. Their voice will be important in shaping the future’s use of technology.

For example, telemedicine has offered the ability for healthcare providers to engage and interact with patients remotely. As the “face” of a trial, CRCs often build relationships with patients and other stakeholders that support the study objectives and encourage patients to participate in future trials. Technologies should help in these efforts and not hinder them.

Hybrid and virtual trials, a new and growing focus on patient-centered trials, and increasingly complex trial designs will continue to impact the duties of CRCs. This environment will continue to pose new challenges and new opportunities. The Association of Clinical Research Professionals (ACRP) states that a dedicated support system including professional development and Principal Investigator (PI) mentoring will enable CRCs to grow professionally and personally. Organizational support for this critical role will continue to be imperative as the dynamics of clinical trials continue to change.

Contact Vitalief for Clinical Trial Solutions and Support

Running a clinical trial requires hard-working staff and problem-proof solutions and support. Whether you need help hiring staff such as a Clinical Research Coordinator, attracting patients, or managing processes, Vitalief offers a solution. Contact us today to learn how our people-first culture can become an asset to your organization.