Clinical Trials 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 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.