Temporary 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)..

The Temporary Regulatory Coordinator supports the regulatory activities for clinical studies conducted through UCI’s Center for Clinical Research. This role manages IRB submissions and approval maintenance, oversees regulatory documentation, and maintains accurate OnCore records while ensuring full compliance with GCP and institutional requirements.

Duties include, but are not limited to:

• Serve as the regulatory point-of-contact for assigned studies, completing IRB submissions, amendments, safety updates, and renewals on time.
• Maintain ISF, TMF, and OnCore records to ensure continuous audit and inspection readiness.
• Coordinate regulatory workflows with sponsors, CROs, CRAs, and PIs to support study start-up and ongoing compliance.
• Assist with AE/SAE reporting, protocol deviations, and safety correspondence according to regulatory and institutional standards.

Required:

• Experience in regulatory/IRB processes and/or clinical research, with knowledge of GCP and human subjects research requirements.
• Proficiency with regulatory and CTMS tools such as OnCore, Veeva Vault, or Medidata Rave.
• Strong attention to detail and accuracy in documentation and regulatory tracking.
• Completion of required trainings (e.g., CITI, GCP, UCLC) or willingness to complete upon hire.
• Ability to read, write, and follow written and oral instructions in English.

Preferred:

• Experience maintaining regulatory files (ISF/TMF) and supporting audit or inspection readiness.
• Prior involvement with study start-up, greenlight activities, and sponsor/CRO communications.
• Familiarity with AE/SAE reporting, safety submissions, and protocol deviation documentation.
• Strong communication and stakeholder management skills.

Total Rewards

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.

$34.73/hour - $35.48/hour

Conditions of Employment:

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 administrative or disciplinary proceedings involving misconduct;

have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.

• California Child Abuse and Neglect Reporting Act
• E-Verify
• Pre-Placement Health Evaluation

Details of each policy…