Temporary Clinical Research Regulatory Coordinator

Overview

Founded in 1965,
UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs.

It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit (Use the "Apply for this Job" box below)..

Job duties include, but are not limited to:

• Independently manage the regulatory lifecycle of clinical research studies, including study activation, IRB submissions, continuing reviews, amendments, reportable events, study closeout, and document archiving.
• Prepare, maintain, and oversee all regulatory documentation, including informed consent forms, HIPAA authorizations, investigator site files, electronic regulatory binders (Complion), and OnCore records to ensure compliance with institutional, FDA, and sponsor requirements.
• Partner with principal investigators, study teams, sponsors, and regulatory agencies to resolve regulatory issues, manage protocol deviations and serious adverse events (SAEs), and ensure studies remain compliant with applicable regulations.
• Lead regulatory readiness for sponsor monitoring visits, audits, and inspections by maintaining audit-ready documentation, resolving findings, supporting quality improvement initiatives, and generating regulatory reports and presentations.

• Bachelor's degree in a related field or an equivalent combination of education and experience.
• Minimum of 3–5 years of regulatory experience supporting clinical research studies.
• Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and regulatory requirements for Phase I–III drug and device clinical trials.
• Experience working in a healthcare or clinical research environment with medical terminology, strong organizational skills, and the ability to independently manage multiple regulatory projects and deadlines.
• Ability to read, write, and follow written and oral instructions in English.

• Experience with electronic clinical research systems, including OnCore, Complion, or similar regulatory management platforms.
• Experience preparing for sponsor monitoring visits, regulatory inspections, and clinical research audits.
• Experience developing study-specific regulatory documents, including informed consent forms, HIPAA authorizations, and other IRB submission materials.
• Strong analytical, communication, and presentation skills with experience creating reports, identifying process improvements, and collaborating with multidisciplinary clinical research teams.

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:

• Background Check and Live Scan
• Employment Misconduct*
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

* Misconduct Disclosure Requirement:
As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any…