Regulatory Affairs Coordinator

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.

To learn more about UC Irvine, visit www.uci.edu .

The UCI Center for Clinical Research was built on the belief that running clinical trials should be a seamless experience.

We work across the UCI enterprise to offer patients, investigators, and industry partners the quick and effortless support they need to participate in and run successful clinical trials. Our goals are to :

Innovate - capitalized on opportunities by developing fresh ideas and innovative approaches to improving our daily work.

Accelerate - Work as a team of teams, driving process simplification, and standardization to surpass our study activation and enrollment targets.

Grow & Inspire - Set the industry bar for world-class experiences for each other, our patients and partners, and elevate our brand as high performers.

For more information on CCR, please visit our website at https : / / clinicalresearch.som.uci.edu.

Your Role on the Team

The Regulatory Affairs Coordinator position will ensure successful management of the regulatory aspects of each study conducted through UCI's Center for Clinical Research.

What It Takes to be Successful

Required :

• Demonstrated problem solving capabilities
• Excellent interpersonal communication skills, both oral and written
• Ability to work under minimal supervision and know how to escalate to proper authorities when needed.
• Ability to work well with teams both within and outside of department
• Ability to prioritize tasks when different stakeholders involved and with competing priorities and deadlines.
• Ability to travel to both medical center in Orange or to main office site in Irvine
• Basic knowledge of Microsoft Word, Excel, PowerPoint
• Ability to comprehend complex documents such as study protocols, guidance documents, and study manuals then synthesize information.
• 2-3 years of experience with regulatory aspects of clinical research including maintaining regulatory documents, submitting IRB application, and working with study sponsors and monitors.
• Associates or Bachelor's Degree. Or the equivalent experience.

Preferred :

• Experience with CTMS, preferably OnCore
• Familiar with FDA Inspection process
• Experience as a clinical research coordinator and / or familiar with the clinical side (versus the regulatory side) of a study.
• CCRP Certified through one of the national clinical research associations (SOCRA or ACRP) or willing to become certified
• Experience with IND submission

Total Compensation

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 expected pay range for this recruitment is $32.12- $52.92 (Hourly).

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
• Legal Right to work in the United States
• Vaccination Policies
• Smoking and Tobacco Policy
• Drug Free Environment

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

Closing Statement :

The University of California, Irvine is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy please visit : https : / / policy.ucop.edu / doc / 4010393 / PPSM-20 .

For the University of California's Anti-Discrimination Policy, please visit : https : / / policy.ucop.edu / doc / 1001004 / Anti-Discrimination .

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 (949) 824-0500 or [email protected].

Consideration for Work Authorization Sponsorship

Must be able to provide proof of work authorization