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Protocol Program Managers

Protocol Project Managers (PPMs)

The Protocol Project Manager (PPM) position was created within the CRSO to eliminate inefficiencies and to provide an organizational infrastructure that would serve each Program and its Principal Investigators as an integrating hub for all the resources required for the seamless and efficient implementation of clinical trials.  PPMs are protocol navigators and are responsible for:

  • coordination of all aspects of study development, start-up, and maintenance
  • serving as the principal liaison between:
  • submitting concepts and protocols to the applicable Program/Disease Site Committee(s)
  • submitting Program/Disease Site Committee approved protocols to the PRC via OnCore
  • submitting applications to UCSF’s Institutional Biosafety Committee (IBC) and  Radiation Safety Committee (RSC)
  • responding to queries or concerns by the various units and review committees involved
  • interacting with CRSO staff to ensure timely completion of regulatory approvals, contract and grant review, and other study start-up procedures to achieve specific timelines for opening studies; providing all CRSO units with a priority list from the Program/Disease Site Committee, keeping a timeline of activity on each protocol in the development queue, and providing the PI and industry sponsor with progress reports as necessary
  • study sponsor interactions, including management of site questionnaires and coordination of site qualification visits.

 

* Investigators should always communicate with the CRSO units through their PPMs.