Manages the clinical research program, operations, and staff. Ensures site research quality by practicing in compliance with departmental Standard Operating Procedures (SOP's), principles of Good Clinical Practice, other applicable governing standards, and applicable federal, state and local regulations. All team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference. Manages the clinical research program through the supervision of staff and all activities of the Clinical Research Unit (CRU). Responsible for implementation and evaluation of staff annual performance objectives and developmental goals. Responsible for the recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, progressive discipline, and retention of staff. Enforces adherence to Prisma Health and departmental policies. Develops and maintains current policy and procedural manual and communicates plans appropriately throughout the organization. Coaches and develops staff. Provides on-going job-related education and training of staff. May develop training materials. Collaborates with Director in the development and implementation of the CRU budget that includes accrual targets and financial objectives; develops accountability standards to ensure targets and budgets are achieved. Maintains knowledge of reimbursement procedures. Assures research related charges are completed and develops research accountability standards, metrics, and reports and identifies areas for improvement. Collaborates with physician research leaders and research staff in the implementation of action plans designed to improve practice research operations and quality assurance functions. Ensures the Prisma Health defined research program goals are met. Collaborates with the physician research leaders and the research medical director, physicians of the practice and in the process of study selection for the research program. Responsible for promoting or marketing research programs to the practice, community and referring physicians. Coordinates research activities with other bases or sponsors. Collaborates with management staff in the implementation of action plans designed to improve research operations and quality assurance functions for the CRU. Responsible for ensuring at the administrative level that all oncology research activities are coordinated with affected departments within the Prisma Health System. Provides oversight and support for site inspections, auditing and monitoring visits, regulatory compliance and quality assurance. Maintains current regulatory knowledge and ensures compliance with FDA and internal regulations. Provide support for site inspections, auditing and monitoring visits, regulatory compliance and quality assurance. Performs other duties as assigned.
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Job Type
Full-time
Career Level
Manager