“There’s nothing more frustrating than being in a role that you know nothing about [and receive] no training for,” says Teri Crumb, MSN, RN, CCRC, a clinical research nurse with Spectrum Health. “You’re not invested in it,” she can attest as a former clinical research coordinator (CRC). Among many downsides, it factors into a very high industry personnel turnover rate, experts agree.
By contrast, when they provide adequate training and ongoing education, employers can help embolden, and hang on to, their best of the best, Crumb says. “I was a coordinator for four years and I’ve been certified for 13 years,” she explains. “My level of confidence in speaking with a physician—giving them comments about how I think a protocol will work, or how it can be better, or how it’s not going to work”—is much higher post-certification, she adds.
“I can [leverage] all my experience and knowledge, and I can back that up with my certification,” Crumb says. “Where you start to shift a coordinator’s perspective on the research is when you get them interested in the role.” Certification begets confidence and confidence begets greater job satisfaction, she says.
The U.S. Food and Drug Administration (FDA) appears to feel the same way about training, Crumb says. When a project of hers was audited by an FDA inspector, Crumb expected the focus from the very start to be on informed consent. “What he actually asked for was my training documents,” she recalls. “It about blew me into the next room.” Lesson learned, Crumb advises CRCs to include training documents as part of the regulatory folder for any study.
Today, Crumb is part of a research consortium designed to provide opportunities for investigator-initiated, multicentered clinical trials. Other members include Margret Kamel, PhD, CCRC, associate director of research projects in the Division of Pediatric Nephrology at Emory University, and Addie Revell, BA, a program coordinator for Nationwide Children’s Hospital.
“The turnover of coordinators at multicenter trials is very significant,” Crumb says. A lack of background and/or training “really impacts our trials” in a negative way, she adds.
Crumb, Kamel, and Revell will share best practices for site training, mentoring, and marketing through an ACRP webinar on “Consorting with Consortiums—Multi-Centered Trial Management” on August 15.
“We’re trying to [share the] perspective [from how] two of our speakers have been on the lead site [in multicentered trials] and they can talk about what it’s like,” Crumb says.
Author: Michael Causey