Research Protocol Subject Matter Expert

Position Summary
Prometheus Federal Services (PFS) is a trusted partner to federal health agencies. We are seeking a Research Protocol Subject Matter Expert to supportDepartment of Veterans Affairs (VA) programs by providing domain expertise analytics and reporting technology transformation process improvement and change management efforts in support of VAs 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 significant experience with program management and 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

• Deep 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

• Bachelors degree in a relevant field (psychology public health life sciences health administration or related discipline); advanced degree preferred.
• Minimum of 10 years of experience in a federal health research environment (e.g. VA NIH DoD or other federal agency research programs).
• Minimum of 5 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 the 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 obtaina PublicTrust clearance.

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 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 clientspecific or governmentmandated 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.