Location: Orange, CA
Cap-Exempt H-1B Position — No lottery required
Overview: 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 (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic. Responsibilities: Independently or under the supervision of the Regulatory Affairs Manager and Assistant Director of Clinical Research Operations, the incumbent is in charge of the regulatory aspect of clinical trials in the UCI Center for Clinical Research (CCR). The role involves managing and conducting complex, multi-phase clinical research protocols from initiation through completion, ensuring compliance with all regulatory requirements for studies involving human subjects. The incumbent will lead study-related meetings, manage the investigator site file, and ensure all necessary regulatory documentation is collected in line with established study protocols. Projects may include industry-sponsored, federally-funded, and/or investigator-initiated studies. Additionally, the incumbent will develop and implement processes for reviewing and overseeing clinical trials, ensuring adherence to study protocols, proper documentation, and accurate data collection in accordance with Good Clinical Practice (GCP), inter