The Protocol Project Manager (PPM) will work in the Early Phase Developmental Therapeutics research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Interventional Trials Resource (ITR), which is a centralized service unit in the Helen Diller Family Comprehensive Cancer Center (HDFCCC) offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out.
A successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.
Duties Include: * Complete pre-activation tasks such as feasibility surveys and assessment with study team * Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee * Identify ancillary committee approval with study team required by a protocol and initiate the process for review * Assist Principal Investigator (PI) with the development of concept sheets, investigational brochure or package insert for Investigational Trials Resource (ITR) regulatory protocol editor for investigator-initiated trials * Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and Institutional Review Board (IRB) submission, contract execution, and billing set up * Ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-out * Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits * Update clinical trial management databases * Assist study team to develop contingency action plans * Flexibility to adapt to changing circumstances * Excellent organizational skills, multitasking and communication both written and spoken.
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.