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).

Tips For Preparing & Hosting a Successful Audit

Regulating AI in Clinical Trials: What ICH E6(R3) Does (and Doesn’t) Say

Explores the Differences Between Auditors and Inspectors in the Clinical Research Industry

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

15 Years of Excellence: FDAQRC's Journey and Future Vision

Tips for a Positive Outcome While Performing a Challenging Audit

How To Find Qualified Patients for Your Clinical Trials
