The Association of Clinical Research Professionals (ACRP) today released the clinical research industry’s first-ever competency guidelines for Clinical Research Coordinators (CRCs).
The groundbreaking guidelines provide a comprehensive roadmap by which individuals and organizations can support the hiring, assessment, and development of entry-level through senior CRCs.
“Variance is the enemy of quality,” says Jim Kremidas, ACRP Executive Director. “The ad hoc manner in which we hire and train CRCs is failing to improve quality in clinical research conduct. We are also failing those at the front lines of clinical research by leaving them without consensus guidance on what we expect from them, and how they can grow in their careers.”
“We hope these guidelines will provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research community,” Kremidas says.
Developed by a task force of diverse industry representatives (see who), the guidelines directly map Version 2.0 of the Harmonized Core Competency Framework developed by the Joint Task Force for Clinical Trial Competency.
“Through extensive vetting – along with review and comments from ACRP’s Workforce Innovation Steering Committee – the guidelines were developed to provide the most far ranging set of competencies required by the broadest set of CRCs working across different types of clinical studies,” adds Beth Harper, ACRP Workforce Innovation Officer. “We hope this initial set of guidelines serves as a strong foundation from which diverse organizations across the globe can adapt to their specific institutional guidelines.”
Putting Competency Theory Into Action
CRCs and their managers can use the guidelines for self-assessment, competence gap analysis, and creating personalized professional development plans.
The actionable document can help research sites of all types: improve trial quality by standardizing competence expectations for CRCs; support CRC recruitment, onboarding, and professional development initiatives; standardize CRC performance management and competence assessment; boost CRC retention through career mapping and development planning; and develop competency-based job descriptions.
The guidelines can also support CROs and sponsors in site selection by equipping them with competence benchmarks to leverage when conducting site assessments.
“We are leading innovation in clinical research workforce development by setting standards that build and validate competence in the individuals conducting the studies,” says Kremidas. “We look forward to this initiative making a lasting impact on workforce quality and supporting our mission to promote excellence in clinical research.”
Today’s announcement follows last year’s release of the Core Competency Framework for Clinical Study Monitoring, which identifies the core competencies required of individuals involved in clinical study monitoring.
Visit Our Initiatives to learn more about how ACRP is leading innovation in clinical research workforce development.