• Office of Clinical Research

The Office of Clinical Research, along with the other committees listed below, collaborate with the Cancer Center’s Clinical Research Advisory Committee in ensuring that appropriate support and oversight is provided to the UC Davis Comprehensive Cancer Center members and sponsors to ensure compliance with all federal, state and local guidelines and requirements.

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
  • Clinical Trial Monitoring
  • Quality assurance
  • Specimen processing
Our office works in collaboration with the clinical care team to provide access to clinical trials and coordinate seamless care during the process.
  • CDA management, pre-site selection visit coordination, feasibility
  • Management of Disease Team Committees
  • Budget development and negotiation, Medicare coverage analysis
  • Contract facilitation, 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
  • Establishing policies and procedures
  • Focused management/development of the Phase I Program and the Sacramento Citywide Oncology Phase I (SCOPE) partnership
  • Protocol development and IND management services
  • Ensuring timely activation of clinical trials Clinical Trial Monitoring
  • Educational Program
  • Quality Assurance Program
  • Program manager dedicated to Phase I program growth and development
  • Responsible for outreach, recruitment through, and operations of, the SCOPE Partnership