Regulatory Affairs Coordinator - 58551-1A

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Updated: Feb 20, 2024
Location: Irvine-Campus
Job Type:
Department: UCI Ctr for Clinical Research

Job Opening ID: 58551

Working Title: Regulatory Affairs Coordinator

Department: UCI Ctr for Clinical Research

Bargaining Unit: RX

FLSA: Non-Exempt

Payroll Job Code: 009335

Job Location: UCI Campus- Irvine

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class: Career

Position Summary:

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.

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

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.

$32.12 - $52.92 (Hourly Rate)

Required:

1-3 years as a Regulatory Affairs Coordinator or the equivalent education or experience

Associates or Bachelor’s Degree. Or the equivalent experience.

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. Basic knowledge of Microsoft Word, Excel, PowerPoint 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 comprehend complex documents such as study protocols, guidance documents, and study manuals then synthesize information. Ability to prioritize tasks when different stakeholders involved and with competing priorities and deadlines. Ability to work well with teams both within and outside of department Ability to travel to both medical center in Orange or to main office site in Irvine

Preferred:

CCRP preferred, but not required

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

Special Conditions Required:

Ability to travel to either Orange Medical Center or main office in Irvine