Framework to Define Competence Requirements for Monitors/CRAs Working in Clinical Research
The Association of Clinical Research Professionals (ACRP) today announces plans to release a harmonized Core Competency Framework for Clinical Research Associates (CRAs) in December that for the first time ever will define the core competencies required of clinical trial monitors/CRAs within the eight core competence domains for clinical research professionals, as defined by the Joint Task Force for Clinical Trial Competence (Learn More about the JTF).
The harmonized CRA Core Competency Framework is the product of a cross-industry, multi-stakeholder Task Force and Steering Committee led by ACRP whose contributors include representation from leading industry and academic organizations across the global clinical research enterprise, including Amgen, Biogen, Celgene, Chiltern, Consortium of Academic Programs in Clinical Research, Covance, Duke Clinical Research Institute, ExecuPharm, Genentech, ICON, INC Research, InVentiv, Novartis, Pfizer, PPD, PRA, and Trevena.
“ACRP looks forward to this landmark announcement and to providing the clinical research enterprise with the first-ever set of harmonized core competencies for clinical trial monitors,” says ACRP Workforce Innovative Officer Terri Hinkley, RN, BScN, MBA, CCRC, FACRP. “This announcement is a major milestone in ACRP’s efforts to collaboratively professionalize clinical research and we look forward to building on these initiatives in support of our mission to promote excellence in clinical research.”
ACRP is seeking additional representation from clinical trial sponsor organizations to contribute to the Steering Committee charged with reviewing and approving the final harmonized CRA Core Competency Framework. Interested parties are invited to contact Terri Hinkley at firstname.lastname@example.org.
The initiative to define core competencies comes as the clinical research enterprise faces a major shortage of CRAs in the workforce.
“We strongly believe the shortage is the result of hiring practices that favor an arbitrary 2-year experience requirement for entry-level CRAs, rather than practices that favor verified competence,” Hinkley says (View ACRP Position Statement, A New Approach to Developing the CRA Workforce). “To impact change and overcome this challenge, we need multi-stakeholder leadership to collaboratively re-imagine the ways in which we support the growth and development of the clinical research workforce, including CRAs.”