office of clincal research at UC Davis

Our office works in collaboration with the clinical care team to provide access to clinical trials and coordinate seamless care during the process.

Welcome

Dr. Karen Kelly © UC RegentsI am pleased to personally welcome you to the UC Davis Comprehensive Cancer Center’s Office of Clinical Research. We are dedicated to conducting clinical trials that promote and support multidisciplinary collaborations. These will assist in the translation of our scientific discoveries to the clinic and ultimately bring more lifesaving treatments to our patients. Our mission is to offer our patients the most advanced, personalized therapies that will lead to a reduction in the morbidity and mortality from cancer. Our website contains a comprehensive overview of our Office of Clinical Research to serve as a guide to the resources and services we offer. We invite you to explore it and to contact us with any questions. Our team is ready to assist you.

Karen Kelly, M.D.
Associate Director for Clinical Research


The office of Clinical Research is responsible for:

  • Protocol development services
  • Regulatory oversight
  • Budget development and approval, contract management
  • Financial oversight
  • Clinical research billing management
  • Protocol and data management
  • Patient care coordination
  • Quality assurance
  • Specimen processing
  • CDA management, pre-site selection visit coordination, feasibility
  • Management of Disease Team Committees
  • Budget development and negotiation, Medicare coverage analysis
  • Contract management, funding awards and billing compliance
  • Preparation and submission of all documentation to institutional review boards and other UCD committees for approval, as needed per protocol
  • Investigator conflict of interest (COI) management
  • Management of regulatory documentation and all protocol related manuals
  • Assist investigators with recruitment and consenting
  • Patient registration, scheduling and care coordination per protocol
  • Liaison to investigator, investigational pharmacy, correlative lab and clinical operations to ensure protocol compliance
  • Liaison to data team and sponsor in regard to safety monitoring and reporting
  • Data and imaging uploads
  • Management of SAE/AE of special interest reporting
  • Respondents to data queries and data cut management
  • Post-study activation scheduling of monitor visits and source access
  • Processing, temporary storage and shipping of protocol-required specimens
  • Correlative kit receiving and ordering
  • Ability to handle tissue and blood samples
  • Liaison to other internal partners to ensure specimens collected per protocol
  • Senior management responsible for establishing policies and workflows
  • Protocol development and IND management services
  • Quality Assurance audits of investigator-initiated trials to further monitor patient safety and regulatory compliance
  • Management of submissions to Scientific Review Committee, Data Safety Monitoring Committee, and Protocol Accrual Monitoring Committee per NCI stipulations
  • Focused management/development of the Phase I Program and the Sacramento Citywide Oncology Phase I (SCOPE) partnership
  • Staff education management
  • Senior members of the units above
  • Direct medical supervision by Director of Phase I and the Executive Director of the Office of Clinical Research
  • Program manager dedicated solely to Phase I program growth and development
  • Program manager also responsible for outreach, recruitment through, and operations of, the Sacramento Citywide Oncology Phase I (SCOPE) Partnership