Learning how to be a good clinical research coordinator (CRC) is important, but understanding the why behind tasks is key to making the job more enjoyable and impactful. “Learning why certain tasks are done a certain way helps put the puzzle together and makes the job even more satisfying,” says Kerry Moore, RN, BS, CCRC, a manager for compliance and regulatory affairs at Le Bonheur Children’s Hospital in Memphis, Tenn.
Digging a bit deeper to understand the rationale behind important tasks and procedures is especially important for fledgling CRCs, agrees Derita Bran, MSN, RN, CCRC, a program director for the Tennessee Clinical and Translational Science Institute at the University of Tennessee Health Science Center. “Light bulbs start to go off” when new CRCs grasp the underlying principles and reasons for standard operating procedures for tasks such as conducting informed consent, Bran says.
Unfortunately, given the pressures of learning the job fast, a high turnover rate, and other factors, some CRCs are given short shrift when it comes to entry-level training in the clinical trial workforce, many experts agree. Training based on rote memorization runs the risk of creating more “robotic” employees, Moore notes. She’s been certified as a CRC through ACRP for 16 years and has seen firsthand the value of good onboarding and ongoing training.
“When you first enter the field as a CRC, it can be overwhelming,” Moore says. When it comes to training new CRCs, it’s helpful to break down the various expectations found within the Code of Federal Regulations to understand which apply to “your day-to-day job and why,” she says.
“We can all read the” guidelines for Good Clinical Practice from the International Council for Harmonization, notes Bran, “but how do they apply to your everyday practice?”
CRCs need and deserve quality training that prepares them for a wide array of scenarios, including withstanding the pressure of a principal investigator (PI) who wants a patient placed in a trial. Sometimes, it’s up to a well-trained, confident CRC to be able to ensure the patient truly belongs in that trial and stand up to the PI if necessary, Moore says.
Bran is also a big fan of regulatory binders as training tools. “When a new CRC begins to understand the source documentation needed to show compliance, [the overall job of being a CRC] begins to make sense,” she says.
“One objective I have for our [workshop at ACRP 2020] is for the attendees to leave with a better understanding of what is needed every day as a research coordinator,” Bran says. “It is our aim to enhance their knowledge and understanding of research to assist them in being successful in research.”
Author: Michael Causey