Regulatory Affairs Coordinator

University of California - Irvine; Fullerton (CA); On-site; USD 52,000 - 85,000; Full time

Job summary

University of California, Irvine is hiring a Regulatory Affairs Coordinator to manage regulatory aspects of clinical trials within the UCI Center for Clinical Research. You will ensure regulatory compliance, coordinate trial documentation, and maintain communication with agencies and study teams.

The role requires 3–5 years of related experience and a Bachelor's degree (or equivalent). Proficiency in OnCore, IRB submissions, Microsoft Office, Zoom, and strong communication skills is essential.

Qualifications

• Bachelor's degree or equivalent experience required.
• 3–5 years of regulatory affairs experience.
• Experience with IRB submissions and regulatory documentation.
• Proficient in MS Office; strong communication skills.

Responsibilities

• Manage multi-phase clinical research protocols from start to finish.
• Ensure IRB, FDA, and sponsor reporting compliance.
• Lead study meetings and maintain investigator site files.
• Use OnCore for accurate trial records and tracking.
• Collaborate with regulatory bodies and sponsor monitors.

Skills

IRB submissions

Microsoft Office

Zoom

Communication

Education

Bachelor's degree or equivalent experience

ACRP certification

SoCRA certification

CCRP certification

Tools

OnCore

Job description

University of California, Irvine is hiring a Regulatory Affairs Coordinator. The role involves managing and overseeing regulatory aspects of clinical trials within the UCI Center for Clinical Research, ensuring compliance with regulatory requirements, coordinating study documentation, and maintaining communication with regulatory agencies and study teams.

Highlights

• Manage and conduct multi-phase clinical research protocols from initiation to completion.
• Ensure compliance with regulatory requirements for human subject studies, including IRB, FDA, and sponsor reporting.
• Lead study-related meetings and maintain investigator site files and clinical trial documentation.
• Use clinical trial management system (OnCore) for accurate record-keeping.
• Required skills include experience with IRB submissions, Microsoft Office Suite, Zoom, and strong communication skills.
• Minimum of 3-5 years related experience as a regulatory affairs coordinator or assistant with a Bachelor's degree or equivalent experience.
• Preferred knowledge includes federal, state, and local clinical trial regulations, various clinical trial types, and certifications such as ACRP, SoCRA, or CCRP.
• May require work outside normal business hours and travel to off-site research locations.
• Hourly pay range is USD $37.56 to $61.91.
• Works closely with clinical research teams, regulatory bodies, and sponsor monitors within a large university medical research setting.