Protocol Project Manager

About the role

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.

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
• Aid 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
• Cookordinate and prepare for sponsor or collaborator visits such as site initiation, audit, and monitor visits
• Aid 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

Qualifications

• BS/BA degree in a related area and/or equivalent experience/training
• Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• Project management or coordinator experience
• Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience
• Demonstrated ability to work within a team environment with faculty and staff at all levels
• Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excel
• Experience working with medical providers and personnel
• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire