Protocol Project Coordinator

Protocol Project Coordinator

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Protocol Project Coordinator to join the Early Phase Oncology research team. The Protocol Project Coordinator (PPC) will work in the Early Phase Oncology research program and serve as a point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, the Clinical Research Support Office (CRSO), and the Office of Clinical Trial Activation (OCTA) which are centralized service units in the HDFCCC/UCSF offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out, and may assist with study operations, including participant management and data entry, as required. This role will be reporting to the Clinical Research Manager (CRM), Principal Investigator (PI), and/or the Associate Director for Clinical Research Programs (AD CRP). Incumbent's duties may include, but will not be limited to, assisting with the regulatory aspects of multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies), help ensure compliance with all relevant regulatory agencies; implement and maintain periodic quality control procedures; ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial maintenance phase and close-out; coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits; interface with departments to assist with obtaining UCSF approval prior to study initiation; maintain relevant regulatory documents; report study progress to investigators and sponsors; update clinical trial management databases, and perform other duties as assigned. 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.
• Assist with protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee.
• Identify ancillary committee approval with study team required by a protocol and assist with the process for review.
• Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator-initiated trials.
• Assist with timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and 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 with study coordination and data collection for multiple studies within the program's portfolio if needed.
• Assist study team to develop contingency action plans.
• Flexibility to adapt to changing circumstances.
• Excellent organizational skills, multitasking and communication both written and spoken.