Temporary Clinical Research Regulatory Coordinator

🇺🇸 Orange, California 🕑 Temporary 💰 $38 - $62 per Hour 💻 Compliance 🗓️ August 21st, 2026

IRB Rive

Edtech.com's Summary

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator. The role involves independently managing the regulatory lifecycle of clinical research studies, ensuring compliance with FDA and institutional requirements, coordinating with investigators and sponsors, and preparing for audits and monitoring visits.

Highlights

Manage regulatory processes for clinical research studies including IRB submissions, continuing reviews, amendments, and study closeout.
Maintain regulatory documentation such as informed consent forms, HIPAA authorizations, and electronic regulatory binders (Complion and OnCore).
Collaborate with principal investigators, study teams, sponsors, and regulatory agencies to address regulatory issues and ensure study compliance.
Prepare for sponsor monitoring visits, audits, and inspections by keeping audit-ready documentation and supporting quality improvement.
Required: Bachelor's degree or equivalent experience with 3-5 years in clinical research regulatory support.
Knowledge of FDA regulations, Good Clinical Practice, IRB processes, and Phase I–III clinical trial requirements is essential.
Preferred experience with electronic clinical research systems such as OnCore and Complion.
Strong communication skills to generate reports and collaborate with multidisciplinary teams.
Pay rate starts at $37.56/hour with a maximum of $61.91/hour.
Temporary full-time position under UCI Temporary Employment Services with comprehensive benefits including paid vacation and sick leave.