|Clinical Research Coordinator (CRC), Lead is a professional level title in the Clinical Research Coordinator Family. They function under the Principal Investigator?s medical license and cannot perform any tasks that by state or local law require a license to perform. They plan, organize, lead, and perform comprehensive advanced level clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the clinical trials. They receive little supervision and are active participants in decisions regarding the clinical research process. They often manage support teams. Impact of decisions is wide in scope affecting both internal and external partners.|
|May manage a team of Clinical Research Coordinators (CRC's), laboratory, and support staff, including hiring, scheduling, workload, compensation, rewards, development, and performance management.|
Coordinates multiple clinical trials simultaneously, and manages multiple Principal Investigator relationships, including establishing and managing multiple budgets, ensuring full compliance with local, state and federal policies and procedures. Serves as the liaison with the sponsor for assigned studies.
Oversees financial accounting of multiple clinical research projects, including budget development, billing reconciliation, and quality review; oversees quarterly review of all Principal Investigator accounts, performing a strategic analysis of PI research portfolios. Develops administrative and financial recommendations for department management and PIs for research portfolio review. Compiles data and documents during internal and external audits, and is ultimately responsible for quality of submissions.
Performs quality assessment of performance and contribute to efficiency and effectiveness of trial operations.
Performs all duties of the Clinical Research Coordinator II.
Four years of clinical research experience (related graduate degree may substitute for two years of experience.)
Maintain Good Clinical Practice certification without lapse.
Maintain Human Subjects Research certification without lapse.
Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA)