Quality Assurance & Regulatory Specialist

🇺🇸 Hybrid - NC

🕑 Full-Time

💰 $70K - $85K

💻 Quality Assurance

🗓️ January 6th, 2026

Edtech.com's Summary

University of North Carolina at Chapel Hill is hiring a Quality Assurance & Regulatory Specialist. The role involves supporting the Research Coordination & Management Unit by monitoring investigator-initiated clinical trials and ensuring adherence to institutional policies, federal regulations, and Good Clinical Practice standards. The specialist develops and maintains quality assurance processes to uphold research integrity and compliance.

Highlights

Monitor investigator-initiated clinical trials across UNC research enterprise.
Develop, implement, and maintain quality assurance processes to ensure compliance and research quality.
Ensure research activities comply with institutional policies, federal regulations, FDA regulations, ICH guidelines, and Good Clinical Practice (GCP) standards.
Provide regulatory compliance guidance, review study documentation, and support best practice development.
Required at least 2 years of clinical trials experience and strong knowledge of GCP, FDA regulations, and ICH guidelines.
Preferred SOCRA or ACRP certification, 5+ years clinical trials experience, 3+ years clinical trial monitoring or auditing experience, and experience with UNC research.
Strong organizational, problem-solving, multitasking skills, and ability to work independently with good judgment.
Full-time permanent position; salary range $70,000 - $85,000 annually.
Position housed in TraCS Institute, under Research Professionals career area.
Must hold relevant post-Baccalaureate degree or equivalent experience; may require terminal degree and licensure.