Director, Clinical Trials Unit

UVA Health•Charlottesville, VA

1d•Onsite

About The Position

The University of Virginia School of Medicine (SOM) seeks a Director for its Clinical Trials Unit (CTU). The Director provides executive oversight, management, and strategic direction for all administrative and operational aspects of the CTU, including compliance, financial, and personnel matters affecting clinical research activities across the School of Medicine. The Director independently develops long-range strategic plans with clear performance metrics, translates those plans into operational programs and policies, and evaluates their effectiveness on an ongoing basis. The Director also serves as a key liaison between the CTU, investigators, sponsors, and University leadership on matters of clinical research strategy and operations. This position reports to the Associate Dean for Clinical Research.

Requirements

Bachelor's degree in health, science, or business
Ten years of progressively responsible experience in clinical research, preferably within an academic medical center or large hospital system, including direct experience supervising clinical research staff and managing administrative teams.
Master's degree may substitute for some experience.
Relevant exempt level experience may substitute for a degree.

Nice To Haves

Master’s degree or PhD in health, science, or business
Substantial experience leading and developing multidisciplinary clinical research teams
Proven experience with change management
Deep understanding of clinical research lifecycles, human subjects’ protection, and grant/contract administration
Experience with OnCore and Huron
Certification through ACRP (e.g., CCRC, CCRA) or SOCRA (CCRP), or an equivalent clinical research credential
Demonstrated financial acumen, including development and oversight of complex, multi-funding-source operating budgets
Highly collaborative individual who can work in a matrixed environment

Responsibilities

Direct all administrative, budgetary, and fiscal operations of the Clinical Trials Unit, preparing analyses to inform both immediate decision-making and long-range management planning.
Monitor and evaluate clinical research activities at UVA, identifying opportunities to improve efficiency. Coordinate the implementation and evaluation of clinical research process improvement efforts, ensuring that UVA competes on quality, consistency, and efficiency. Advise senior administrators in implementing programs, new initiatives, and special projects.
Translate strategic and tactical business plans into clinical research operational plans.
Develop, maintain, and foster partnerships throughout the University. Ensure all programs, activities, and series comply with university, state, and federal regulations.
Serve as the primary liaison between the CTU and investigators, sponsors, contract research organizations, the IRB, regulatory agencies, and University leadership on matters of clinical research operations and compliance.
Provide leadership and supervision to Clinical Trials Unit (CTU) staff, establishing performance standards and accountability while promoting professional development, continuous learning, and career growth.
Establish the strategic direction, goals, performance metrics, implementation strategy, and policies of the Clinical Trials Unit.
Develop and implement clinical research policies and standard operating procedures for clinical research activities performed within the School of Medicine.
Provide the oversight and management of clinical research mentoring, training and continuing education for all research personnel, including investigators, clinical research coordinators and any ancillary personnel involved in clinical research activities.
Provide oversight of the clinical billing process for clinical research conducted within the SOM utilizing Medical Center services, ensuring compliance with CMS regulations. Identify and implement training needs of the SOM clinical research staff.
Recruit, lead, and manage a team of clinical research regulatory coordinators, providing fee-for-service regulatory support to investigators across the institution.
Recruit, lead, and manage a team of Clinical Research Coordinators (CRCs), providing fee-for-service, subject-facing clinical research support to investigators across the institution.
Recruit, lead, and manage a team of budget and billing coordinators, providing fee-for-service budget development, budget negotiation, and invoicing support to investigators across the institution.
Recruit, lead, and manage a team of project managers, providing fee-for-service multi-site management support to investigators serving as lead PI on multi-site studies.
Oversee the operation and management of the Clinical Research Units.
Participate in the development and implementation of clinical research infrastructure, processes, and training necessary to expand clinical research operations at the UVA community affiliate sites.
Provide the infrastructural and end-user support for the clinical systems used to support clinical research at UVA, such as the CTMS and the eRegulatory systems.
Assist research teams with Clinicaltrials.gov, the mandatory trial registration process, ongoing record maintenance and final results submissions.
Provide infrastructural support and clinical research expertise to the clinical investigative staff throughout the institution which includes, but is not limited to, protocol and informed consent development, IND/IDE submissions, FDA inspections, and general operational and/or compliance questions.
Develop and manage the Clinical Trials Unit operating budget, demonstrating sound financial stewardship and accountability for resources.
Other duties as assigned.