ACRP Calls for Focus on Competence as Solution to Shortage of Monitors in Clinical Research Workforce


Jeremy Glunt
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New CWWeekly Article Calls Industry-Wide Practice of Requiring Two Years’ Experience Before Assigning Monitors to Clinical Trials “Major Issue” Contributing to Shortage

Washington, DC – The Association of Clinical Research Professionals (ACRP) continues calling for a groundbreaking shift in the clinical research industry: elimination of the commonly accepted and practiced two-year experience requirement for entry-level Monitors/Clinical Research Associates (CRAs) in favor of competence-based employment practices.

An article in today’s CWWeekly (“The ongoing CRA shortage: Competency versus experience”) notes that “at least 10,000 open CRA positions” exist in the United States alone and that “ongoing concerns about a global shortage” were rekindled last week at the Clinical Trial Collaborations conference in Boston, Massachusetts.

“There has been an exponential demand and growth in the clinical studies space in the past five or 10 years,” ACRP Executive Director Jim Kremidas is quoted in the article. “We have a shortage not only of CRAs, but of Investigators, clinical coordinators and more. The entire industry is under stress with the amount of research that’s being conducted and the resources available.”

While the CWWeekly article notes there is “some dissent over various reasons for the shortage, most agree that a major issue is the industry-wide practice that requires CRAs to have a minimum of two years of experience before being assigned to a trial.”

“ACRP, among others, is working to change that mindset, while still ensuring quality in the profession,” the article continues.

“The most important factor is the requirement of two years of experience before being considered a qualified CRA,” Kremidas is quoted as saying. “It’s a random marker. Time in a job is not necessarily indicative of whether somebody does it well or not.

“We suggest throwing the two year arbitrary experience requirement out the window and focus on the competencies required for the job,” Kremidas continues. “We’d like to define an industry standard that everyone agrees upon, one that says if a person has this type of education, training and experiences, they are qualified to be a good CRA.”

ACRP initiated calls for changes in CRA hiring practices in a September 2015 Position Paper, A New Approach to Developing the CRA Workforce.

ACRP’s CRA Workforce Task Force, announced late last year, will convene in April at the ACRP 2016 Meeting & Expo in Atlanta, Georgia, to define the core competencies required of entry-level CRAs. The task force further charged with developing measures of competence and advocating for standardization of identified competencies across the clinical research enterprise.

Click Here to learn more about a Harmonized Core Competency Framework for the Clinical Research Profession.

About ACRP

ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based nonprofit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research.