Director, Clinical Trials Unit

Commonwealth of VA Careers; Charlottesville (VA); On-site; USD 150,000 - 230,000; Full time

Job summary

The University of Virginia School of Medicine 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 plans with metrics, translates plans into programs, and evaluates effectiveness.

Qualifications

• Bachelor's degree in health, science, or business.
• Ten years of progressively responsible experience in clinical research, preferably in academic medical center or large hospital system.
• Supervisory experience of clinical research staff and administrative teams.
• Preferred: certifications (ACRP/SOCRA) and strong financial oversight.
• Experience leading multidisciplinary clinical research teams and change management.

Responsibilities

• Direct all administrative, budgetary, and fiscal operations of the CTU.
• Monitor clinical research activities and drive process improvements for quality and efficiency.
• Translate strategic plans into operational programs and policies.
• Serve as liaison between CTU, investigators, sponsors, CROs, IRB, and University leadership.
• Provide leadership and supervision to CTU staff and set performance standards.
• Develop clinical research policies and SOPs for activities within the School of Medicine.
• Oversee mentoring, training, and continuing education for research personnel.
• Oversee billing processes and ensure CMS compliance in clinical research.
• Recruit, lead, and manage regulatory coordinators, CRCs, budget/billing coordinators, and project managers.
• Oversee operation of the Clinical Research Units and support UVA infrastructure.

Skills

Leadership

Budget management

Regulatory compliance

Stakeholder engagement

Strategic planning

Education

Bachelor's degree in health, science, or business

Master's degree may substitute

Tools

OnCore

Huron

Job description

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.

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 research 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.
  

Minimum Qualifications

• Education: Bachelor's degree in health, science, or business
• Experience: 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.

Preferred Qualifications

• 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

Physical Demands

This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

Salary will be commensurate with education and experience.

This is an exempt-level, benefited position. Learn more about UVA benefits .

This is a restricted position, which is dependent on funding and is contingent upon funding availability.

This position is based in Charlottesville, VA, and must be performed fully on-site.

To learn more about UVA and the Charlottesville area, visit UVA Life and Embark CVA .

Application review will begin after September 1, 2026.

Background checks and pre-employment health screenings will be conducted on all new hires prior to employment.

This position will not consider candidates who require immigration sponsorship now or in the future.

Job Profile

J1004 - Academic Administration Management 4

Career Stream and Level

Management-M4

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment .