Research Protocol Subject Matter Expert

Research Protocol Subject Matter Expert

Prometheus Federal Services (PFS) is a trusted partner of federal health agencies. We are seeking a Research Protocol Subject Matter Expert to support Department of Veterans Affairs (VA) programs by providing domain expertise analytics and reporting, technology transformation, process improvement, and change management efforts in support of VA's research project management operations. This role will bring deep knowledge of the research protocol lifecycle, regulatory and compliance considerations, and site-level research operations.

The ideal candidate has experience with management of multi-functional teams, analytics and reporting including experience working in federal data environments, change management methodologies, and research site engagement and support. Core competencies include:

• Subject matter expertise in research protocol governance and administration
• Process analysis and transformation mindset
• Strong client/stakeholder-facing communication and consulting skills
• Ability to operate independently while advising and leading across technical and programmatic teams
• Comfort navigating regulated, compliance-driven environments

Essential Duties and Responsibilities:

• Provide expert guidance to performance tracking and management, change management, process improvement, and technology transformation efforts on all phases of the research protocol lifecycle, including protocol development, IRB/regulatory submission and review, activation, amendment management, continuing review, and closeout.
• Contribute knowledge on best practices for protocol tracking, documentation standards, and key performance metrics for research program management.
• Identify lifecycle bottlenecks and data-driven improvements to performance management and tracking.
• As needed, advise on the development of standard operating procedures (SOPs) and job aids related to protocol management.
• Partner with program and technical teams to design future-state workflows, including integration with data platforms, tracking systems, and reporting tools.
• Support change management activities, including stakeholder engagement, training, and communication planning for new or revised processes.
• Contribute subject matter expertise to system requirements, tool selection, and workflow design efforts tied to protocol management technology.
• Collaborate with cross-functional teams including regulatory affairs, data governance, IT, and program management.
• Contribute to reporting and metrics development to track protocol management performance and process transformation outcomes.
• Stay current on relevant regulations, guidance, and industry best practices and advise leadership accordingly.
• Communicate complex technical or domain-specific concepts in a clear and accessible manner to array of audiences.

Minimum Qualifications:

• Bachelor's degree in a relevant field (public health, life sciences, health administration, or related discipline); advanced degree preferred.
• Minimum of 7 years of experience in a federal health research environment (e.g., VA, NIH, DoD, or other federal agency research programs).
• Minimum of 4 years of experience in clinical or health research administration, protocol management, or research compliance.
• Demonstrated experience supporting the full research protocol lifecycle, including IRB/regulatory processes.
• Experience supporting or leading process improvement or transformation initiatives within a research or clinical operations environment.
• Strong understanding of research site operations and the challenges faced by site-level research staff.
• Experience leading development of standardized, repeatable analytical reporting products, dashboards, and performance tracking systems.
• Excellent written and verbal communication skills, with the ability to translate complex regulatory and operational concepts for varied audiences.
• Strong stakeholder management skills and experience working across multidisciplinary teams.
• Authorized to work in the U.S. indefinitely without sponsorship.
• Ability to obtain a Public Trust clearance.

Preferred

Qualification:

• Experience with relevant regulatory frameworks or agency-specific…