Clinical Trials Subject Matter Expert (SME)

Fairfax, VA
Full Time
Experienced
Position Summary
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.

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 recruiting@pfs.us. 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".
Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status



Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*