POSITION OBJECTIVE 

The Clinical Research Office Director supports the Comprehensive Cancer Center Clinical Research Office, collaborating with the medical director, associate director, and deputy associate director for clinical research. The director coordinates and oversees all clinical research within the center, engaging entities conducting patient-based research through hospital and institution-based clinical trials units. Reporting to the associate director for administration and the associate director for clinical research, the director ensures compliance with the cancer center support grant, develops strategies and policies for coordinated clinical trial activity across consortium institutions (University Hospitals and Cleveland Clinic), and guides the protocol review and monitoring system and the data safety and monitoring plan, including clinical trial audits and federal reporting to the national cancer institute, food and drug administration, and clinicaltrials.gov. The director is a member of the clinical trials leadership group, organizes the monthly clinical research operation committee, collaborates with cancer center leaders to develop priorities for programmatic and infrastructure resources, reviews and allocates internal funding for clinical research pilot projects, updates clinical trials information to the national cancer institute and clinicaltrials.gov, and coordinates responses to solicitations from the national cancer institute cancer therapy evaluation program and other relevant programs.

ESSENTIAL FUNCTIONS

Oversee all aspects of clinical research at the Case Comprehensive Cancer Center. Work with the administrative directors of the Seidman Cancer Center and Taussig Cancer Institute clinical trials units to coordinate cancer center support grant clinical trial oversight, including coordination of protocol development, tracking, trial activation, and reporting. Review and revise clinical trial standard operating procedures to ensure they are consistent across sites; identify and address inconsistencies in policies and procedures among sites; coordinate consistent clinical trials reporting and documentation; maintain consistent data management. Provide education, cultural competency, minority accrual support, and training of clinical investigation personnel, clinical research education and compliance, and clinical trials staff. Provide feedback to Case Comprehensive Cancer Center senior leadership regarding the performance of the administrative directors of the clinical trials units at Seidman and Taussig. The administrative directors of the clinical trials units at Seidman Cancer Center and Taussig Cancer Institute report to the person in this position in all aspects of cancer center support grant funding opportunity announcement clinical trials compliance. Maintain a consistent presence at all Case Comprehensive Cancer Center sites through regular meetings. (20%)

Schedule, develop the agenda, and provide minutes for the monthly clinical research operation committee and clinical trials working group meetings, focusing on operations, coordination, national cancer institute compliance, and reporting monthly accrual, summaries, and action items from protocol review and monitoring committee and data safety and monitoring committee meetings. (10%)

Work with the clinical research operation committee to coordinate clinical trials review at disease team groups between institutions, including protocol review and sign-off to promote cross-institution alignment for clinical investigation and accrual. Participate regularly in disease team group meetings and ensure these teams are meeting effectively. (10%)

Collect data for cancer center support grant data table 3 reporting, including clinical trial accrual to meet standards of accrual rates, minority accrual by disease team, a minority patient accrual plan for each protocol, plans for accrual moni