The Director, Clinical Research Unit will play a critical, integrative role leading and managing the Clinical Research Unit (CRU) to support clinical research, operations, and administrative needs. The Director will also provide clinical research management through expertise and leadership across medical specialties within Prisma Health–Midlands. The Director will facilitate processes so that investigators and research staff can grow and expand their clinical investigations and clinical research portfolios.
All team members are responsible for bringing life to our Purpose Statement – Inspire health. Serve with compassion. Be the difference – through every action and every interaction at work.
Provides effective leadership by coordinating and integrating services to enhance the Clinical Research Unit (CRU). Provides direct oversight and management of the daily operations and team members of the CRU.
Oversees clinical research infrastructure and service work and in collaboration with the Medical Director of Research, implements CRU operations to include study and regulatory coordination; research core facility services; quality assurance and safety; and the integration of research into clinical operations.
Implements research-driven performance metrics, identifies needs, and prioritizes research activities in order to plan strategically and flexibly and to respond tactically and resourcefully for the effective operational management of clinical trials and clinical research services of the CRU. Participates in the review of clinical research protocols and other study documents. Assesses research projects for feasibility in collaboration with investigators and other entities involved in the research.
Oversees the departmental and study budgeting process, operational management of clinical research expenditures, and the generation of new research revenue from sponsors.
Provides leadership for the integration efforts with Prisma Health–Upstate to establish processes to open and conduct studies simultaneously at both affiliates. Establishes and manages virtual prn research group across Prisma Health to maximize utilization of study coordinators across the system.
Establishes policies and procedures that guide and support the provision of clinical research operations to ensure compliance and improve efficiencies within the CRU. Communicates and educates departmental team members, investigators/study staff, and ancillary departments. Establishes and serves on research-related committees.
Facilitates the maintenance and utilization of research electronic systems including clinical trial management system and subject stipend system.
Performs other duties as assigned.
Education: Bachelor's degree in Health related field or business administration; Master's degree preferred.
Experience: 7 years of clinical research operations and clinical trials regulatory environment with some supervisory experience, preferably director-level experience
Number and Type of Employees Supervised: 8 direct reports.
Licensure, Registry or Certification Required: none
Knowledge, Skills, or Abilities: Competent to work at the highest technical level related to research conduct while considering the business implications of current and future study management. Experience in managing clinical trial management system electronic applications required. Experience with research metric reporting and interpretation including but not limited study finances, study start-up time lines, and subject screening and recruitment.