The medical director provides overall direction and oversight in the clinical operations of the cancer clinical research operations (CCRO) overseeing the ten multi-disciplinary disease groups (MDG). The medical director works with cancer center leadership, directly reporting to the AD of Clinical Research and the CTO operations/administrative director to develop strategic plans for the CCRO and provide quality service to all stakeholders including study participants, physician investigators, regulatory authorities, and trial sponsors. The CCRO medical director will work closely with the medical director of the regional research sites (RRS) to integrate research through the MDG’s into the community.
The CCRO medical director will be an experienced physician with cancer area of focus and active clinical researcher at the academic rank of associate professor or professor. They will have extensive experience as a clinical trial investigator and have completed all appropriate training. They will be knowledgeable of research operations including clinical conduct, regulatory compliance, budget development, contracting, and strategic planning.
Interested candidates may contact Dr. Margaret Kasner -
[email protected]
Primary Responsibilities:
· Oversee the following MDGs: Brain, Breast, Head and Neck, GI, GU, Gyn, Hematologic Malignancies, BMT-Immune and Cellular Therapies, Lung, Melanoma
· This includes evaluating strengths and weaknesses with regards to trial portfolios, accrual, and integration of regional research sites (in conjunction with the director of community based clinical research) to set, review, and adjust biannual goals for each MDG.
· Provide guidance to disease research teams on prioritization of clinical trials based on catchment area, institutional priorities, and trial performance, in collaboration with the Office of Community Outreach and Engagement and the director of community based clinical research.
· Act as the primary liaison between faculty and CTO leadership regarding clinical research and will work to identify areas of improvement and resolve conflicts
· Work with the cancer center leadership to review and resolve or escalate clinical, regulatory, or budget issues with investigators, service line, other departments, and internal/external partners
· Actively participate in the cancer center clinical research leadership council and lead the clinical trial advisory council, comprised of key cancer center stakeholders responsible for the success of the clinical research mission
· Facilitate the successful onboarding of investigators, and provide ongoing support for career development
· Provide oversight of the development and review of standard operating procedures (SOPs) for the CCRO
· Work with CTO operations/administrative director and all other relevant stakeholders to optimize timely trial activation and high-quality study conduct
· In conjunction with the Associate Director of Clinical Research, assist in the integration of CTO activities with biostatistics, investigational drug pharmacy, clinical trial specimen processing, the Protocol Review and Monitoring System (PRMS), and the Data & Safety Monitoring (DSM) system as appropriate
· Adhere to NCI P30 Cancer Center Support Grant (CCSG) guidelines, and support the cancer center in preparing the CCSG application and other necessary annual updates including non-competitive renewal submissions to NCI