Research Protocol Subject Matter Expert

• 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 Functions 
Reasonable Accommodations Statement 

To succeed in this job, an individual must be able to satisfactorily perform each essential duty. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

• 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. 

• 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. 

• Experience with relevant regulatory frameworks or agency-specific research policy (e.g., VA research and development policy).
• Prior experience supporting the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), or other federal healthcare agencies. 
• Familiarity with VA data domains, research program data, or enterprise VA systems. 
• Experience supporting IT-enabled process transformation, including requirements gathering or systems implementation for research administration platforms.

Compensation & Benefits

PFS offers a benefits package that may include health, dental, and vision coverage; flexible spending accounts; disability and life insurance; a retirement plan; paid time off; and other programs to support employees and their families. Learn more about PFS Benefits.

Equal Employment Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, parental status, national origin, age, disability, genetic information, political affiliation, military service, or other status protected by law.

Accommodations

PFS is committed to providing equal employment opportunities to all applicants. If you require a reasonable accommodation during the application or interview process, please contact us at View email address on us.fitly.work. Reasonable accommodations are available to ensure applicants with disabilities have equal access to the hiring process, in accordance with the Americans with Disabilities Act (ADA) and applicable laws.

Workplace Health, Safety, and Compliance

This position may be subject to client‑specific or government‑mandated vaccination, health, or safety requirements, which may change over time.

Texting Privacy Policy and Information:

• Message type: Informational; you will receive text messages regarding your application and potentially regarding interview scheduling.
• No mobile information will be shared with third parties/affiliates for marketing/promotional purposes.
• Message frequency will vary depending on the application process.
• Msg & data rates may apply.
• Opt out at any time by texting "stop".