Temporary Clinical Research Regulatory Coordinator

University of California, Irvine•Orange, CA

14h•Onsite

About The Position

UC Irvine is seeking a Temporary Clinical Research Regulatory Coordinator to manage the regulatory lifecycle of clinical research studies. This role involves ensuring compliance with institutional, FDA, and sponsor requirements, preparing and maintaining regulatory documentation, and partnering with various stakeholders to resolve regulatory issues. The position is temporary and reports to the UCI Temporary Employment Services (TES) Department, with potential for various work schedules and benefits available for temporary employees.

Requirements

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.
Must be able to provide proof of work authorization.

Nice To Haves

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.

Responsibilities

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.