Regulatory Compliance Lead - HIPAA & Human Subjects

The Henry M. Jackson Foundation for the Advancement of Military Medicine; Bethesda (MD); On-site; USD 68,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Retirement plans

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Compliance Specialist to help ensure research programs meet local, state, and federal rules, including HIPAA and IRB processes.

This role supports the Surgical Critical Care Initiative (SC2i) under USU/DoD oversight, coordinating regulatory duties and documentation across sites. Responsibilities include preparing and submitting protocols via eIRB systems, maintaining tracking databases, and ensuring

Qualifications

• Bachelor's Degree required in life sciences, public health, or health administration related fields preferred.
• Minimum of 3–5 years of experience required.
• Willingness to learn regulatory standards, SOPs, and checklists with high accuracy.

Responsibilities

• Assist with regulatory review of research protocols for human subjects and HIPAA compliance.
• Prepare, submit, and manage protocols through eIRB systems; respond to reviewer comments.
• Monitor regulatory requirements and assess impact on SC2i research activities.
• Update regulatory tracking systems with protocol statuses and approvals.
• Review regulatory documents for completeness under supervision to ensure submission readiness.
• Maintain DSAs, MTAs, and DUAs to support compliant collaborations.
• Maintain regulatory files and audit-ready records per retention requirements.
• Prepare and maintain ClinicalTrials.gov registrations and study records as directed.
• Coordinate deadlines and milestones with investigators to keep records current.
• Develop and revise SOPs/SOGs and regulatory process docs for consistency.
• Maintain records across the portfolio and report on submission statuses.
• Foster communications with investigators, IRBs, and regulatory offices across SC2i sites.
• Assist with regulatory training for research personnel and track completion.
• Participate in regulatory meetings and continuous improvement activities.
• Collect documentation and relay status updates to investigators under supervision.

Skills

Regulatory compliance

HIPAA familiarity

IRB processes

Attention to detail

Microsoft Office

Communication skills

Task management

Education

Bachelor's Degree

Job description

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Compliance Specialist to help ensure research programs meet local, state, and federal rules, including HIPAA and IRB processes.

This role supports the Surgical Critical Care Initiative (SC2i) under USU/DoD oversight, coordinating regulatory duties and documentation across sites. Responsibilities include preparing and submitting protocols via eIRB systems, maintaining tracking databases, and ensuring