Regulatory Affairs Coordinator

🇺🇸 Orange, CA 🕑 Full-Time 💰 $36 - $59 per Hour 💻 Compliance 🗓️ May 10th, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Regulatory Affairs Coordinator to manage and conduct complex clinical research protocols at the UCI Center for Clinical Research. The role involves ensuring compliance with regulatory requirements, maintaining regulatory documentation, and coordinating submissions to the Institutional Review Board, FDA, and sponsors while supporting Principal Investigators and study coordinators in non-cancer clinical trials.

Highlights

Manage regulatory aspects of multi-phase clinical trials from initiation to completion.
Lead study meetings and maintain the investigator site file and regulatory documentation.
Ensure compliance with Good Clinical Practice, SOPs, and university policies.
Prepare and submit IRB applications, amendments, continuing reviews, and reportable events.
Maintain communication with IRB, FDA, sponsor monitors, and multi-level research networks.
Use clinical trial management system OnCore for maintaining trial information.
Required skills include experience with regulatory submissions, Microsoft Office suite, Zoom, and excellent communication.
Minimum 3-5 years' related experience as a regulatory affairs coordinator with a bachelor's degree or equivalent.
Compensation ranges from $35.77 to $58.96 per hour with comprehensive benefits.
Preferred qualifications include knowledge of clinical trial regulations, various types of clinical trials, and research certification such as ACRP, SoCRA, or CCRP.