Assistant Regulatory Affairs Coordinator - Hybrid

University of California, Irvine; Orange (CA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

Retirement savings plan

Employee assistance program

Job summary

The University of California, Irvine's Chao Family Comprehensive Cancer Center is seeking an Assistant Regulatory Affairs Coordinator to support cancer‑related clinical research with regulatory management of protocols in line with federal regulations and SOPs. You will coordinate submissions to IRB, FDA and related committees to ensure timely trial activation.

Under the Regulatory Program Manager, you will maintain OnCore data, liaise with sponsors and regulators, and ensure compliant, efficient

Qualifications

• Bachelor's degree or equivalent with exposure to regulatory processes.
• Experience coordinating committees and regulatory submissions is preferred.
• Ability to communicate complex regulatory information clearly.

Responsibilities

• Manage and prepare submissions for IRB, FDA and other committees.
• Assist regulatory coordination across DOTs, PRMC, DSMB, IBC, RSC and EIP.
• Maintain regulatory information in the clinical trial management system (OnCore).
• Coordinate communication with sponsors and regulatory groups as needed.

Skills

Interpersonal skills

Documentation

Attention to detail

Regulatory knowledge

Communication

Education

BA/BS or equivalent

Tools

OnCore

Microsoft Office

Job description

Who We Are

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.

The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus‑wide multidisciplinary matrix organization whose goal is to promote and enhance cancer‑related research and patient care at UC Irvine. The CFCCC provides research resources to its ~175 members engaged in research and offers multidisciplinary cancer care to its patients.

Your Role on the Team

Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the Cancer Center by providing comprehensive, regulatory management of cancer‑related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.

Responsibilities related to regulatory coordination activities include managing and preparing submissions of modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, but not limited to, Disease‑Oriented Teams (DOTs), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Board (DSMB), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Epidemiology Infectious Prevention (EIP). The ARAC is responsible for effectively shepherding protocols through the regulatory committee process in a timely manner to ensure activation of trial and for all regulatory aspects of the protocols assigned.

In addition, the ARAC serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi‑level research network, including attending Disease‑Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

What It Takes to be Successful

Required

• Ability to interact with the public, faculty, and staff
• Ability to establish and maintain files and records
• Access to transportation to off‑site research locations
• Willingness to work as a supportive, cooperative member of an interdisciplinary team
• Demonstrated high‑level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence
• Demonstrated ability to organize and prioritize a complex and dynamic workload
• Ability to multitask and meet deadlines, despite interruptions
• Ability to independently exercise discretion and sound judgment
• Ability to work collegially and cooperatively in a small office and to establish and maintain cooperative working relationships
• Demonstrated skill in interacting with persons of various social, cultural, economic and educational backgrounds
• Ability to prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and/or in environments with frequent workload changes and competing demands
• Skill in working independently, taking initiative and following through on assignments
• Ability to think critically, compile data from various sources, analyze data, and prepare reports.
• Ability to work both independently and as part of a team
• Ability to take initiative and demonstrate strong commitment to duties
• Ability to perform ongoing needs analysis and recommend solutions to resolve concerns.
• Ability to work within a deadline‑driven structure
• Demonstrated experience in maintaining flexibility and adaptability while implementing institutional change
• High level of integrity and honesty in maintaining confidentiality
• Foster and promote a positive attitude and professional appearance
• Strong attention to detail
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint)
• 1–3 Years of related work coordination work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience
• Experience with submitting to various institutional research committees, i.e., Institutional Review Board, Protocol Review Monitoring Committee, Data Safety Monitoring Board, Institutional Biosafety, Radiation Safety Committee, and Epidemiology Infectious Prevention.

Preferred

• Experience with cancer‑related research.
• Knowledge with various types of human subject clinical trials i.e., National Group, Industrial, and Investigator‑authored.
• Experience with clinical trial management systems, preferably OnCore.

Special Conditions

• May require study management coordination outside of normal business hours.
• May require travel to satellite sites.

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.

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.

• 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

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].

Must be able to provide proof of work authorization

Must be able to provide proof of work authorization