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Project & Data Management for Clinical Trials

To increase the speed and efficiency of clinical research protocols, the ACTRI is offering project management and support services to investigators. ACTRI can help launch and manage your studies by facilitating the initiation and execution of clinical protocols, enabling you to focus on your research.

See Project Management recharge rates here. 

Contact us at CRSI-Navigator@health.ucsd.edu


Project Management Services

Applied to clinical trials, project management is critical to ensuring that trials are set up, enrolled, conducted, and reported on-time and according to budget. The ACTRI Clinical Trials Project Manager (PM) independently oversees and manages research protocols. They review, triage and track resources and service requests across ACTRI and UCSD research units. As part of a shared service, the PM coordinates multiple clinical trials at various stages of development, implementation and close out. They serve as a key point of contact for research studies, working with sponsors and CROs. The PM is flexible enough to assess and mitigate potential hurdles in study activation and conduct, to assure rapid response from the study team.

Example Scenarios:

  • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Provide efficient updates on trial progress to the PI with respect to project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • A study needs a tracking tool to ensure subjects are being contacted at needed milestones, payments are completed, and key points of contact are notified.