Temporary Clinical Research Regulatory Coordinator

University of California, Irvine; Orange (CA); On-site; USD 44,083 - 63,369; Full time

Job summary

University of California, Irvine seeks a Regulatory Affairs professional to independently manage the regulatory lifecycle of clinical studies, including activation, submissions, amendments, and closeout. You will prepare and oversee all regulatory documents and collaborate with investigators, sponsors, and regulators to maintain compliance.

Ideal candidates have 3–5 years regulatory experience, knowledge of FDA/GCP/IRB processes, and proficiency with OnCore or Complion in a healthcare research

Qualifications

• Bachelor's degree or equivalent in a related field.
• 3–5 years of regulatory experience for clinical research.
• Knowledge of FDA, GCP, IRB processes for Phase I–III trials.
• Ability to read/write English and manage multiple projects.

Responsibilities

• Independently manage regulatory lifecycle of clinical studies (activation, submissions, amendments, SAEs, closeout).
• Prepare and oversee regulatory documents (informed consent, HIPAA, files, electronic binders).
• Collaborate with investigators, sponsors, and regulators to resolve issues and ensure compliance.
• Lead readiness for sponsor visits, audits, and inspections with audit-ready documentation.

Skills

Regulatory management

FDA regulations

GCP

IRB processes

Project management

Education

Bachelor's degree in related field

Tools

OnCore

Complion

Job description

Your Role on the Team

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.

What It Takes to be Successful

Required:

• 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.

Preferred:

• 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.

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.

Pay Rate:$37.56/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 may be reviewed by visiting the following page - https://hr.uci.edu/new-hire/conditions-of-employment.php

Temporary Employment

This is a temporary employment recruitment reporting to the UCI Temporary Employment Services (TES) Department. Interviewing and hiring is based on internal hiring needs and how well the candidate's experience matches the assignment requirements. Certain temporary assignments may require clearance of a health physical or require a valid California Driver’s License for driving university vehicles.

The majority of our temporary positions are Monday – Friday, 8:00 a.m. – 5:00 p.m. We also have occasional part‑time, weekend, and evening hours available, depending on the assignment. Comprehensive benefits options are also available for temporary employees, including paid vacation, holidays, and sick leave.

Please note that we recruit for this position on an on‑going basis to build a talent pool of potential candidates. When a position becomes available, we will review applicants at that time. Due to the volume of applications that we receive, only those candidates selected for interviews will be contacted.

Applicants with prior employment with UC or UC Irvine, please include this work experience on both your application and resume.

Closing Statement

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.

We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at [phone] or [e-mail].

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization.