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: Under the supervision of the Regulatory Affairs Manager and the Assistant Director of Clinical Research Operations, the incumbent is responsible for supporting the regulatory aspect of the clinical trials in the UCI Center for Clinical Research (CCR). The incumbent is responsible for the management of multiple-phase research protocols from initiation through completion of research projects with human subjects. The incumbent will conduct study-related meetings, manage the investigator site file, and collect all necessary regulatory documentation in compliance with established study protocols. Projects may include industry-sponsored, federally-funded, and/or investigator-initiated studies. Assist development and processes for review and oversight of clinical trials conducted by investigators, ensuring study protocols are followed and appropriate documentation is kept and collected according to Good Clinical Practice (GCP), internal standard operating procedures (SOPs), and University policies