Assistant Regulatory Affairs Coordinator

University of California System•Orange, CA

28d•$27 - $44•Hybrid

About The Position

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. The Assistant Regulatory Affairs Coordinator position will work directly with the Lead Regulatory Coordinator to ensure successful management of the regulatory aspects of each study conducted through UCI's Center for Clinical Research. This position will work a hybrid, onsite/from home, schedule and report on site to both Irvine and Orange offices as directed.

Requirements

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
Maintains high level of professionalism as this role requires staff to be the "face" of the study to various stakeholders including industry study sponsors, CROs, PIs, and other study collaborators. Failure to do so would result in affecting relationships and reputation of the unit and affect future collaborations.
Excellent problem-solving skills and quick-thinker capabilities
Proficient in Microsoft Office to be able to generate reports and documents in Word, Excel and PPT
Basic understanding of clinical trials/research
Strong communication skills as this role requires constant contact with all study stake holders including study sponsors, CROs, PIs, and various units within the department
Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
Must be willing to and able to commute to two different office locations: Irvine and Orange