Decentralized Clinical Trials Program Lead

Prometheus Federal Services; Fairfax (VA); On-site; USD 170,000 - 200,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Job summary

Prometheus Federal Services is seeking an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) for VA health programs. You will coordinate regulatory submissions, sponsor engagement, and study operations while ensuring quality and compliance across teams.

The role emphasizes strategic oversight and hands-on study coordination, including protocol development, IRB submissions, and vendor agreements, with a focus on VA research environments.

Qualifications

• Bachelor's degree required; Master's preferred.
• Experience in VA clinical research coordination is preferred, oncology experience highly desirable.
• Minimum of ten (10) years of experience in implementing and overseeing clinical research regulatory requirements.
• Strong organizational, interpersonal, and written/oral communication skills.
• Ability to work independently in a lead role while collaborating with multidisciplinary teams.
• Hands-on experience with REDCap for clinical research data capture and management.

Responsibilities

• Lead and oversee Decentralized Clinical Trial (DCT) data auditing, oversight, and end-to-end study coordination.
• Facilitate cross-functional meetings with internal teams and external stakeholders, including FDA, sponsors, and VA groups.
• Contribute to protocol development, regulatory submissions, and study documentation (IRB, ORD SOPs, CCRS reports).
• Identify and onboard new DCT opportunities, translating concepts into executable study designs.
• Develop study protocols, budgets, CDAs, SOWs, CRADAs, and TSAs for new studies.
• Coordinate daily clinical research operations: regulatory submissions, screening, enrollment, data entry, and study management.
• Guide patients through participation activities, ensuring protocol compliance and engagement.

Skills

Clinical research coordination

DCT data auditing

Regulatory compliance

Stakeholder management

REDCap

EMR/EHR experience

Independent lead role

Education

Bachelor's degree

Master's degree preferred

Nursing degree preferred

Tools

REDCap

EMR/EHR systems

Job description

Prometheus Federal Services is seeking an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) for VA health programs. You will coordinate regulatory submissions, sponsor engagement, and study operations while ensuring quality and compliance across teams.

The role emphasizes strategic oversight and hands-on study coordination, including protocol development, IRB submissions, and vendor agreements, with a focus on VA research environments.