Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

Req : 147613

Location: Orange, California

Division: School of Medicine

Department: UCI Center for Clinical Research

Position Type: Full Time

Salary Range: USD $35.77/Hr. to USD $58.96/Hr.

Under the supervision of the Regulatory Affairs Manager and Assistant Director, the Coordinator manages the regulatory aspects of clinical trials. Responsibilities include initiating and completing multi‑phase protocols, ensuring compliance with regulations for human subjects, leading study meetings, managing investigator site files, and preparing all required regulatory documentation per study protocols. The role also involves submitting to IRB, FDA, sponsor monitors, managing reporting timelines, providing regulatory support to investigators and coordinators, and maintaining data in OnCore.

The Coordinator may work across multiple locations and community sites.

• Submit IRB applications (initial, amendments, continuing reviews, reportable events) and manage documentation.
• Maintain effective working relationships across the Health System and external agencies.
• Ensure accurate and timely reporting to IRB, FDA, and sponsor monitors.
• Maintain clinical trial information in OnCore and adhere to institutional policies.
• Provide regulatory guidance to investigators and study coordinators for non‑cancer trials.
• Communicate with research network levels and external regulatory groups.
• Develop and implement processes for reviewing and overseeing clinical trials in line with GCP, SOPs, and University policies.

• Experience submitting IRB applications (initial, amendments, continuing reviews, reportable events).
• Strong customer service skills and ability to establish effective working relationships.
• Excellent written and verbal communication skills in English.
• Ability to conduct research, evaluate information, and prepare clear, concise reports and correspondence.
• Proven organizational skills, attention to detail, and ability to manage a complex workload and meet deadlines.
• Proven problem‑solving and judgment skills.
• High level of integrity and confidentiality.
• Flexibility and adaptability.
• Proficiency with Microsoft Office, Zoom, and related software.
• Experience establishing and maintaining files and records.
• HS graduation and sufficient experience to perform assigned duties.
• Minimum 3–5 years of related experience as a regulatory affairs coordinator or assistant RAC with a Bachelor’s degree or equivalent.

• Knowledge of clinical trial federal, state, and local regulations.
• Working knowledge of various types of human subject clinical trials.
• Research certification (e.g., ACRP, SoCRA, CCRP).
• Current CITI training certification.
• In‑depth understanding of regulatory affairs regulations in Phase I–III drug and device trials, IRB submissions, and regulatory study aspects.

• May require study management outside normal business hours.
• May require travel to off‑site research locations.

In addition to the salary, the position offers benefits including medical insurance, sick and vacation time, retirement savings plans, and discount programs.

• Background check and live scan.
• Compliance with employment misconduct policies.
• Legal right to work in the United States.
• Vaccination policies.
• Smoking and tobacco policy.
• Drug‑free environment.
• California Child Abuse and Neglect Reporting Act.
• E‑Verify.
• Pre‑placement health evaluation.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti‑Discrimination Policy.

UCI provides reasonable accommodations for applicants with disabilities upon request.