Clinical Research Regulatory Specialist

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; Bethesda (MD); On-site; USD 68,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Health savings account (HSA)

Retirement plans

Job summary

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is seeking a Regulatory Affairs Specialist to ensure MCCRP research protocols comply with local, state, and federal regulations for human subjects, animals, recombinant DNA, and HIPAA.

The role supports the John P. Murtha Cancer Center Research Program at Walter Reed Bethesda. Responsibilities include assisting IRB submissions, protocol lifecycle management, training documentation, and maintaining

Qualifications

• Bachelor's Degree required.
• Minimum of 3–5 years of experience required.
• Regulatory knowledge for human subjects, animal, and HIPAA regulations.

Responsibilities

• Assist with IRB submissions and consent forms.
• Help manage protocol lifecycle and regulatory documents.
• Ensure compliance with local, state, federal, and DoW regulations; maintain study binders.
• Prepare monitoring reports and follow-up letters with summaries of findings.
• Assist with training certifications and study personnel documents.
• Support publication clearance for MCCRP manuscripts and presentations.

Skills

Regulatory knowledge

Excellent writing

Communication skills

Organizational skills

Time management

Interpersonal skills

Oncology experience

Education

Bachelor's Degree

Tools

MS Word

Excel

PowerPoint

Adobe

Job description

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is seeking a Regulatory Affairs Specialist to ensure MCCRP research protocols comply with local, state, and federal regulations for human subjects, animals, recombinant DNA, and HIPAA.

The role supports the John P. Murtha Cancer Center Research Program at Walter Reed Bethesda. Responsibilities include assisting IRB submissions, protocol lifecycle management, training documentation, and maintaining