Competency Based Programs Contribute to Early Clinical Research Professional’s Training – FDAQRC

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Explore the benefits of on-the-job training for Clinical Research Professionals

How a Competency Based Program will Contribute to Early CRP Training

This poster, presented during SQA’s 2025 Annual Meeting, explores the topic of formal education versus on-the-job professional training for Clinical Research Professionals (CRPs). Senior Quality Auditor Amy Fox argues that trainings and education for CRPs must go beyond what is required for regulatory compliance and focus on competency.

Research suggests that CRPs feel more competent after five years of experience in their role or two years of experience with a professional certification. However, formal education and age did not factor into self-perceived competence and level of expertise.

These findings pose a problem in the industry because there are no mandated educational requirements, certifications, or professional training programs. These mandated requirements are present in other roles in the medical industry but not for CRPs.

This poster was first presented at SQA 2025 Annual Meeting and Quality College by Senior Quality Auditor Amy Fox. Amy joined FDAQRC in 2022. She has 20+ years of experience in clinical trial operations and regulatory compliance. Amy holds a Doctor of Health Administration (DHA) and numerous certifications including being a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP).

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