Regulatory Assistant

🇺🇸 Chapel Hill, NC 🕑 Full-Time 💰 $41K - $52K 💻 Compliance 🗓️ May 15th, 2026

IRB

Edtech.com's Summary

The University of North Carolina at Chapel Hill is hiring a Regulatory Assistant. This role involves managing regulatory documents to support oncology clinical trials, ensuring compliance with federal regulations and institutional policies, maintaining electronic regulatory binders, coordinating IRB applications, and assisting with monitoring and audit preparations.

Highlights

Manage and maintain regulatory essential documents and electronic regulatory binders for oncology clinical trials.
Communicate with sponsors and monitors about regulatory document status and provide required documentation.
Track and update pending regulatory actions and attend study team meetings, including taking minutes.
Enter IRB approval information and upload study documents into the OnCore clinical research management system within deadlines.
Prepare regulatory binders for monitoring and audit visits and resolve regulatory findings.
Prepare and submit IRB applications for continuing reviews, personnel modifications, and IND safety reports.
Involvement in process improvements, including developing SOPs and mentoring new regulatory team members.
Required skills include proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and knowledge of regulatory policies for clinical research and IRBs.
Minimum education requirement is a bachelor’s degree or equivalent combination of training and experience.
Salary range is $40,945 to $52,000 per year.