Clinical Trials Subject Matter Expert (SME)

sor 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.

Essential Duties and 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
Minimum Qualifications
• 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

Compensation & 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. Learn more about PFS Benefits.

PFS benefits, compensation, and bonuses are determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract and organizational requirements.

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 [email protected]. 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:
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• Message frequency will vary depending on the application process.
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