University of North Carolina at Chapel Hill
Assistant Director, Clinical Trials Quality Assurance Program
🇺🇸 Chapel Hill, NC
🕑 Full-Time
💰 TBD
💻 Quality Assurance
🗓️ August 20th, 2025
Edtech.com's Summary
- Design and maintain audits for clinical trial compliance with IRB approvals, sponsors, regulations, and UNC policies.
- Lead reviews including directed investigations related to noncompliance or regulatory inspections.
- Report to the Director of the Clinical Research Compliance Office and collaborate with offices like OHRE and Sponsored Research.
- Must master regulations from OHRP, FDA, Public Health Service, and NIH governing clinical trials.
- Require relevant post-baccalaureate degree or equivalent experience with a bachelor's degree plus 3 years in sponsored research administration.
- Experience in university clinical research administration and familiarity with FDA, OHRP guidelines, and Good Clinical Practice (GCP).
- Preferred qualifications include a master’s degree in science or health/life sciences, 5+ years relevant experience, strong communication skills, and ACRP or SOCRA certification.
- Full-time, permanent staff appointment with 40 hours per week.
- Part of UNC's Research Compliance Services supporting the $1 billion research enterprise.
- Position designated as a Campus Security Authority under the Clery Act with related reporting responsibilities.
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