University of California, Irvine is hiring an Assistant Regulatory Affairs Coordinator. This role supports clinical research efforts at the Chao Family Comprehensive Cancer Center by managing regulatory submissions and communications with institutional committees, sponsors, and regulatory bodies to ensure timely activation and compliance of cancer-related clinical trial protocols.
Highlights
Manage and prepare regulatory submissions for clinical trials including modifications, renewals, adverse events, and study closures.
Coordinate interactions with Institutional Review Board (IRB), FDA, and other regulatory and compliance committees.
Serve as liaison to sponsors, National Clinical Trials Network groups, pharmaceutical companies, and research entities.
Maintain accurate regulatory information using clinical trial management systems, preferably OnCore.
Perform ongoing communication with Disease-Oriented Teams and comply with National Cancer Institute reporting guidelines.
Requires experience submitting to various research committees and knowledge of human subject clinical trials.
Must demonstrate strong communication, problem-solving, organizational, and multitasking skills.
Proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint) is required.
Compensation range is USD $31.11 to $51.25 per hour.
Preferred qualifications include experience with cancer-related research and clinical trial management systems.