This guest blog post by Michael Causey comes from our partner Association of Clinical Research Professionals (ACRP).
Having a set of core competencies will be “incredibly helpful” in addressing the current clinical research associate (CRA) shortage, says Bonnie Miller, RN, MS, a clinical research consultant and president of the Association of Clinical Research Professionals (ACRP) Northern California Chapter.
“This job requires tangible standardized role competencies,” says Miller, who is also an adjunct faculty member with San Francisco State University’s College of Extended Learning and with the University of California, Berkeley Extension. Tenure should not be the consideration when judging whether someone is ready to be promoted, she adds.
Ironically, that lack of benchmarked core competencies contributes to the very workforce shortage that industry so desperately wants to correct, says ACRP Workforce Innovation Officer Terri Hinkley, RN, BScN, MBA, CCRC, FACRP.
“ACRP, working with a number of organizations, is calling for an end to the arbitrary practice of requiring two years of monitoring experience for entry-level CRAs/monitors,” Hinkley adds. It’s a practice that evolved over time, but which has pretty much eliminated the CRA pipeline and resulted in an ongoing shortage of new entrants to become CRAs.
By focusing on competency and not tenure, “we can identify, educate, train, and prepare the future clinical research workforce,” Hinkley says.
Clear descriptions of core competencies and skillset expectations will benefit both employees and supervisors, Miller adds. “Managers will be better able to write and hire to a competency-based job description, perform meaningful performance reviews, and assess promotion readiness,” she says. “This will benefit those transitioning into clinical research, as well as those making lateral or vertical moves in the clinical trial workplace.”
The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP's on-demand eLearning courses equips your staff with not only an understanding of the core concepts of Good Clinical Practice (GCP) but how to put those concepts into action through a series of ongoing "knowledge checks" and real-world scenarios likely to be encountered during a clinical trial. The courses provide formal training on the International Conference on Harmonization (ICH) Guidelines for GCP, the globally recognized standard for the conduct of clinical trials, for clinical research professionals. Developed by leading Subject Matter Experts, the ACRP GCP training library is a collection of titles designed to train your staff on the most current standards of care. For more information about the Good Clinical Practices training library, click here.