Senior Clinical Research Program Manager

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary: Goldbelt is seeking a Senior Clinical Research Program Manager to support the Naval Medical Center Portsmouth (NMCP) Clinical Investigation Department (CID) in Portsmouth, Virginia. This position serves as the Clinical Program Manager and Government-designated Key Personnel for the contract.

The Senior Clinical Research Program Manager provides scientific leadership, research regulatory expertise, personnel supervision, and overall program management for contractor-supported clinical research activities at NMCP.

This is a senior clinical/scientific research leadership position requiring demonstrated experience with IRB- and/or IACUC-regulated research. The Program Manager serves as a research Subject Matter Expert (SME), provides continuity and sustainability across clinical and combat casualty care research programs, supervises multidisciplinary contractor research personnel, and maintains day-to-day authority for contractor task order performance.

The position supports research and scholarly activities involving the Combat Trauma Research Group (CTRG), Otolaryngology, Pediatrics, Nursing Research, Orthopedics, Women's Health, Emergency Medicine, Graduate Medical Education (GME) programs, the CID Animal Facility (ANFAC), and other NMCP research stakeholders.

The research portfolio encompasses human-subject and animal research, Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) protocols, Quality Improvement (QI), Quality Assurance (QA), exempt and non-human-subject research, and related scholarly activities.

This is a full-time, primarily onsite position at Naval Medical Center Portsmouth. Telework may be authorized in accordance with contract requirements and Government approval.

Essential Job Functions:

• Provides overall leadership, management, and supervision of contractor personnel supporting NMCP clinical and scientific research activities.
• Serves as the contractor's primary day-to-day management representative and maintains authority to act for the contractor on operational contract matters.
• Provides continuity and sustainability for contractor-supported clinical and combat casualty care research programs.
• Serves as a research Subject Matter Expert (SME) supporting investigators conducting IRB- and IACUC-regulated studies.
• Provides scientific and regulatory research guidance to NMCP departments and research personnel.
• Supports Government Principal Investigators (PIs) and Clinical Protocol Developers in the formulation of research concepts, conceptual frameworks, study objectives, research strategies, and related scientific activities, subject to final Government approval.
• Supports research activities across the lifecycle from research concept and protocol development through execution, regulatory compliance, data collection, reporting, presentation, publication, and dissemination.
• Maintains and monitors research regulatory documentation, approval requirements, and associated timelines.
• Monitors protocol deviations and associated corrective actions.
• Supports research portfolio prioritization and alignment with the NMCP mission.
• Tracks research data deliverables, reporting requirements, contract deliverables, milestones, and schedules.
• Supervises multidisciplinary contractor personnel supporting clinical protocol development, clinical research coordination, human-subject research, animal research, bioengineering/biomechanics, simulation, and related research activities.
• Ensures qualified contractor personnel are assigned and maintained across the program and monitors staffing vacancies and continuity risks.
• Coordinates contractor employee onboarding, Common Access Card (CAC) and access requirements, mandatory training, and personnel readiness.
• Maintains appropriate contractor supervision and the non-personal services relationship required for contractor personnel.
• Ensures contractor personnel comply with applicable IRB/IACUC protocols, research procedures, privacy requirements, and DoD/DHA requirements.
• Supports investigator-initiated human and animal research, regulatory submissions and amendments, informed-consent documentation, scientific review, IRB/IACUC coordination, research databases, specimen activities, study reporting, and related research functions.
• Conducts research seminars for contractor personnel and coordinates Government-approved research training when authorized.
• Attends research conferences and meetings and supports development of scientific presentations when required.
• Coordinates with the Contracting Officer's Representative (COR), Contracting Officer, NMCP CID leadership, Government PIs, and other authorized…