Protocol Project Manager

UCSF•San Francisco, CA

3d•$47 - $58

About The Position

The Protocol Project Manager (PPM) will work in the GU Oncology 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 various departments within UCSF providing support. 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.

Requirements

Excellent organizational skills, multitasking and communication both written and spoken.

Nice To Haves

Thrive in a fast-paced environment
Take initiative
Resolve problems
Provide clarity in ambiguous situations
Go-getter with excellent relationship building skills
Team player who can also work independently

Responsibilities

Complete pre-activation tasks such as feasibility surveys and assessment with study team; lead pre-site selection teleconference calls
Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee
Serve as Disease Site Committee Administrator, set agendas, and lead meetings in close collaboration with the Site Committee Chair
Identify ancillary committee approval with study team required by a protocol and initiate the process for review; complete various applications to ancillary committees such as radiation safety and biosafety applications.
Assist PI with the development of concept sheets, protocols, investigational brochure or package insert, and consent forms working in close collaboration with the Protocol Development team 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 IRB submission, contract execution, and billing set up; prepare reports and trackers to keep the Disease Site Committee appraised of activation status for all new protocols
Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations
Prepare and make submissions to IRB; prepare and maintain regulatory binders
Collaborate with ancillary departments to set up operational aspects of new studies (e.g. pharmacy, radiology, and labs)
Ensure policies mandated by the UCSF IRB, 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.
Lead trainings within the Disease Site Committee and HDFCCC
Develop and write group specific SOPs and policies
Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.); serve as registration coordinator to help investigators maintain these varied accounts
Flexibility to adapt to changing circumstances.
Excellent organizational skills, multitasking and communication both written and spoken.