Office of clinical research
Our office works in collaboration with the clinical care team to provide access to clinical trials and coordinate seamless care during the process.
I 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
The clinical and data management team is comprised of experienced clinical research coordinators. This unit has staff dedicated to screening, enrolling and managing the day-to-day needs of patients on clinical trials. They extend the exceptional care provided by the doctors and nurses at the UC Davis Comprehensive Cancer Center. The other half of the team is comprised of dedicated coordinators who take the patient’s clinical records and abstract them into research databases, making it possible for investigators to monitor the safety and efficacy of clinical trials. Together with the investigators, the unit helps ensure the success of clinical trial participation and help streamline and navigate clinical trial enrollment.
The Regulatory Unit of the Office of Clinical Research (OCR) is responsible for regulatory oversight of OCR trials. As mandated by the U.S. Food and Drug Administration (FDA), clinical trials must be reviewed and approved by an Institutional Review Board (IRB). The Regulatory Unit obtains IRB approval of new clinical trials as well as modifications and continuing reviews of those trials. The Regulatory Unit provides support to the UC Davis Comprehensive Cancer Center principal investigators and clinical research coordinators to ensure compliance with local, state and federal regulations.
Members of this team ensure that trials are designed and implemented per compliance with local, state and federal regulation (e.g., Food and Drug Administration, Office of Human Research Protections, Good Clinical Practice/International Council on Harmonisation). The protocol development officer supports our investigators in creating a framework that efficiently tests their hypotheses, while the quality assurance officer coordinates the Quality Assurance Committee and the review of investigator-initiated trials to ensure protocol compliance, patient safety, and data integrity. Other members of this unit facilitate the Scientific Review Committee, the Data Safety Monitoring Committee, the Protocol Accrual Monitoring Committee, as well as coordinating educational opportunities for research staff.
The Business Unit oversees protocol feasibility and site selection for industry funded oncology clinical trials, and is responsible for overall financial management for the life of the trial. The Business Unit Analyst is responsible for budget development, including completion of the formal Medical Coverage Analysis. The Analyst develops and negotiates clinical trial budgets with various funding sources, works closely with the Health System Contracts office to finalize new and revised contracts, and consults with OCR staff to ensure that the terms of the contract are being followed.
The Specimen Processing Unit is responsible for processing biological specimens procured according to protocol, ensuring specimen integrity as well as preparation and shipping accordingly.
The Phase I Unit is comprised of the program manager and senior members of the Clinical Unit who work directly under the associate director for clinical research and the executive director of the Office of Clinical Research to manage study portfolio development and programmatic directives aimed at patient recruitment, study completion and publication benchmarking. The Phase I team meets to assess study status, screenings and enrollments, adverse events and dose-limiting toxicities and to ensure overall that these complex early phase studies are accrued to, finished and data integrity is maintained. The Program Manager fields calls from referring sites and responds to Phase I study inquiries, communicating and coordinating with pertinent study personnel to streamline patient referral to accrual timelines. Additionally the Program Manager is responsible for the daily operations and development of the Sacramento Citywide Oncology Phase I (SCOPE) program. The SCOPE program broadens patient access to early-phase clinical trials through a cooperative care model unique to the greater Sacramento area.