UC Davis Health
Clinical and Translational Science Center

Clinical Trials Navigation and Management Services

The Clinical Trials Office assists investigators, scholars and staff in the conduct of clinical research by providing managed navigation through research-related resources and services available at UC Davis. Whether you have an idea, are applying for a grant, or trying to implement a new trial, our experts are available to assist with expert consultations or hands-on activities. We guide investigational teams through the myriad of local, state, and federal requirements. Our team of highly trained clinical research coordinators, regulatory analysts, and budget specialists are available to assist investigators in conducting and supporting all phases of a clinical research protocol.

When you contact the Clinical Trials Office for services, the Navigation Project Manager will review your project needs, discuss specifics and create a project plan that may involve additional experts from other areas of knowledge. Consultations are free of charge. Should you need a team to manage your study, a Resource Prioritization Committee will review your request and advise on the next steps. We will allocate staff based on expertise and availability. We track project hours in a time tracking system and provide a detailed account of all hours spent. If the study is funded, services are charged to the grant at the hourly rates, and billed monthly.

Note to Early Career Investigators and Scholars

Investigators who have not yet competed successfully for a substantial NIH (National Institutes of Health) research grant but have received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) and those within 10 years of completing a terminal research degree, medical residency, or equivalent may request additional financial consideration. Clinical and Translational Science Center management will consider requests based on the scientific merit of the project.

Primary Contact

Kate Marusina, Ph.D., M.B.A. 
Director, Clinical Trials Office
916-703-9177 | kmarusina@ucdavis.edu

Services

Full Study Management: A comprehensive team approach including clinical research coordination, regulatory, finance, recruitment, EMR research, to projects led by K scholars, early-stage investigators (ESI), and NIH grantees (with emphasis on ESI). Submit application for cost estimate

Clinical Research Coordinator Pool ($54/hr.). Our experienced clinical research coordinators offer mentoring and support to investigators and staff to conduct clinical research.

Dedicated Research Clinic/Center (CTSC Clinical Research Center). Submit the protocol for cost estimates.

Regulatory Support ($62/hr.) Our regulatory analysts offer mentoring and support to investigators and staff with IRB submissions, protocol development, and regulatory compliance.

  • Develop investigator-initiated protocols
    • Guide investigators through IRB’s HRP-503 (investigator-initiated protocol template)
  • Assist with IRB submissions
    • Review IRB submission packages for completeness
    • Guide response to IRB requests for modifications to secure IRB approval
    • Train research staff to use IRBNet
    • Assist with IRB ancillary approvals through completion
    • Clarify IRB reporting criteria and timelines for Reportable New Information (RNI)
    • Develop Corrective and Preventative Action (CAPA) plans
    • Prepare for sponsor and regulatory agency audits
    • Guide through single IRB review requirements and reliance processes
    • Advise on CITI account management
  • Investigational new drug (IND) and investigational device exemption (IDE) development
    • Review IND/IDE applications for content and completeness
    • Review IND exemption requests
    • Assist with mandatory reports to the FDA