Quality Assurance & Regulatory Specialist

🇺🇸 Hybrid - NC 🕑 Full-Time 💰 $70K - $90K 💻 Quality Assurance 🗓️ April 9th, 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, ensuring adherence to institutional policies, federal regulations, and Good Clinical Practice standards. The specialist will develop and maintain quality assurance processes and serve as a resource for regulatory compliance and best practice development.

Highlights

Monitor investigator-initiated clinical trials across the UNC research enterprise.
Develop, implement, and maintain quality assurance processes for research integrity and compliance.
Serve as a resource for regulatory compliance, study documentation review, and best practice guidance.
Require knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
Minimum of a relevant post-Baccalaureate degree or Bachelor’s degree with 3+ years relevant experience; terminal degree and licensure may be required.
At least 2 years clinical trials experience, with clinical trial monitoring or auditing preferred.
Strong organizational, problem-solving, and multitasking abilities, with excellent communication and collaboration skills.
Experience with decentralized, multi-site, and/or FDA-regulated trials is valued.
Preferred certifications include SOCRA or ACRP; preference for candidates with 5+ years clinical trials and 3+ years monitoring or auditing experience.
Full-time permanent position with a hiring range of $70,000 - $90,000 annually.