Clinical Trials Subject Matter Expert (SME)

Prometheus Federal Services • Fairfax, VA

6d

About The Position

Prometheus Federal Services (PFS) is a trusted partner to federal health agencies. We are exploring the addition of an experienced Clinical Trials Subject Matter Expert (SME) to provide leadership in planning, coordinating, and executing decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The Clinical Trials SME will serve as a trusted advisor to government and industry stakeholders, overseeing complex clinical research activities, ensuring regulatory and ethical compliance, and advancing scalable decentralized research models. This role combines strategic oversight with hands-on study coordination, supporting protocol development, regulatory submissions, sponsor engagement, and day-to-day execution of clinical studies. The ideal candidate brings deep experience within VA research environments, strong regulatory acumen, and the ability to collaborate across multidisciplinary teams to deliver high-quality, compliant clinical research initiatives.

Requirements

• Bachelor's degree required; Master's degree or Nursing degree preferred
• Demonstrate experience in VA clinical research coordination, with oncology research experience strongly preferred
• Minimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirements
• Proven ability to manage multiple complex priorities with a high level of attention to detail and accuracy
• Exceptional organizational, interpersonal, and written and oral communication skills
• Experience working with electronic medical records (EMR/EHR) systems in clinical or research settings
• Ability to operate independently in a lead role while collaborating effectively within multidisciplinary teams
• Strong analytical and problem-solving skills, with the ability to resolve regulatory and operational challenges
• Hands-on experience with REDCap for clinical research data capture and management
• Ability to work in the U.S. indefinitely without sponsorship
• Ability to obtain a public trust

Nice To Haves

• Master's degree or Nursing degree

Responsibilities

• Lead and execute Decentralized Clinical Trial (DCT) data auditing, oversight, and end-to-end study coordination to ensure data integrity and protocol adherence
• Direct and facilitate cross-functional meetings with internal teams, and external stakeholders, including FDA representatives, industry sponsors, and VA research groups, to advance DCT initiatives
• Author, review, and contribute to high-impact DCT documentation and deliverables, including VA Institutional Review Board (IRB) and Office of Research and Development (ORD) Standard Operating Procedures, training webinars, Centralized Clinical Research System (CCRS) reports, executive-level slide decks, and stakeholder engagement sessions
• Engage with sponsors to identify, evaluate, and onboard new DCT opportunities, translating research concepts into executable study designs
• Develop and negotiate study protocols and research agreements, including budgets, Confidential Disclosure Agreements (CDAs), Statements of Work (SOWs), Cooperative Research and Development Agreements (CRADAs), and Tele-Health Service Agreements (TSAs) for new studies
• Oversee and coordinate daily clinical research operations, including regulatory submissions, patient screening and enrollment, data entry, and comprehensive study management
• Support and guide patients through study participation activities, ensuring protocol compliance, accessibility, and participant engagement
• Plan, organize, and lead study team meetings, driving alignment, accountability, and progress toward key milestones
• Monitor study performance metrics and collaborate closely with Principal Investigator (PIs) to ensure timeliness, deliverables, and regulatory obligations are met
• Enforce adherence to federal, VA, and ethical research regulations, maintaining continuous compliance throughout the study lifecycle
• Maintain complete, accurate, and audit-ready research records in accordance with VA, FDA, and Good Clinical Practices (GCP) standards
• Synthesize and communicate research progress, risks, and findings to sponsors, investigators, and senior stakeholders

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees