Regulatory Affairs Coordinator

University of California, Irvine is hiring a Regulatory Affairs Coordinator. The role manages regulatory compliance for clinical trials at the UCI Center for Clinical Research, ensuring adherence to study protocols and regulatory requirements from initiation through completion. The coordinator leads study-related meetings, handles documentation, and maintains communication with regulatory bodies and sponsors. Highlights Manage regulatory aspects of multi-phase clinical research protocols, including submission and reporting to IRB, FDA, and sponsors. Maintain investigator site files and clinical trial documentation in OnCore system. Work closely with Principal Investigators, study coordinators, and compliance groups to ensure regulatory adherence. Required skills include experience with IRB submissions, strong communication, organizational abilities, and proficiency in Microsoft Office, Zoom, and related software. Minimum 3-5 years of experience as a regulatory affairs coordinator or similar role, with a Bachelor’s degree or equivalent experience. Preferred qualifications include knowledge of clinical trial regulations, research certifications (ACRP, SoCRA, CCRP), and current CITI training certification. Ability to work across multiple research sites including UCI Medical Center and community clinics. Compensation ranges from $35.77 to $58.96 per hour. May require work outside normal business hours and travel to off-site research locations. University offers comprehensive benefits including medical insurance, retirement plans, and paid time off. #J-18808-Ljbffr