HIPAA & IRB Compliance Specialist

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

Benefits offered by this job

Medical, dental, vision

Retirement plans

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. seeks a Regulatory Compliance Specialist to ensure research programs comply with local, state, and federal regulations for human subjects research and HIPAA.

The role supports SC2i within USU Department of Surgery, coordinating protocol submissions, regulatory tracking, and DSAs/MTAs. Qualifications include a Bachelor's Degree and 3–5 years of experience, strong attention to detail, and proficiency with Microsoft

Qualifications

• Bachelor's Degree required; life sciences, public health, or health administration preferred.
• Minimum of 3–5 years of experience required.
• Willingness to learn and follow regulatory standards with a high degree of accuracy.
• Basic understanding of human subjects research regulations (HIPAA, IRB processes).
• Proficiency with Microsoft Office and tracking systems.
• Strong written and verbal communication; ability to manage multiple tasks.
• Ability to obtain and maintain a T1/Public Trust background check.

Responsibilities

• Assist regulatory review of research protocols to ensure compliance with federal, institutional, and consortium requirements.
• Prepare, submit, and manage research protocols through eIRB; resolve reviewer comments to secure approvals.
• Monitor regulatory requirements and advise on compliance actions for SC2i research activities.
• Enter and update protocol, approval, and study status in regulatory tracking systems.
• Review regulatory documents for completeness and formatting accuracy.
• Assist with DSAs, MTAs, and DUAs to support compliant collaboration and data sharing.
• Maintain regulatory files and records to ensure audit readiness and traceability.
• Prepare ClinicalTrials.gov registrations and study records under senior regulatory oversight.
• Coordinate deadlines and milestones with investigators and study teams.
• Develop, revise, and maintain SOPs/SOGs and regulatory process documents.
• Maintain regulatory records and retention compliance across portfolios.
• Conduct periodic reviews of regulatory documentation for accuracy and completeness.
• Maintain relationships with investigators, IRBs, and consortium partners for regulatory coordination.
• Assist with regulatory training and monitor completion records.
• Participate in regulatory meetings and continuous improvement efforts.

Skills

Attention to detail

Clear communication

Time management

Willingness to learn

Education

Bachelor's Degree

Tools

Microsoft Office

eIRB systems

Job description

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. seeks a Regulatory Compliance Specialist to ensure research programs comply with local, state, and federal regulations for human subjects research and HIPAA.

The role supports SC2i within USU Department of Surgery, coordinating protocol submissions, regulatory tracking, and DSAs/MTAs. Qualifications include a Bachelor's Degree and 3–5 years of experience, strong attention to detail, and proficiency with Microsoft