Regulatory Affairs Lead – Oncology Research

The Henry M. Jackson Foundation for the Advancement of Military Medicine; Bethesda (MD); Sur place; USD 68 000 - 95 000; Plein temps

Résumé du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Affairs Specialist to ensure MCCRP research protocols comply with applicable regulations at local, state, and federal levels.

You will support USUHS and Walter Reed Bethesda with IRB submissions, protocol lifecycle management, and regulatory documentation. Ideal candidates have a Bachelor’s degree and 3–5 years of regulatory experience in research; oncology exposure is a plus.

Qualifications

• Bachelor's Degree is required.
• 3-5 years of regulatory experience required.
• Basic knowledge of human subjects' research regulations.
• Excellent writing skills and attention to detail.
• Strong organizational and time-management skills.
• Excellent communication and interpersonal skills.
• Oncology experience is a plus.
• Proficiency with MS Word, Excel, PowerPoint, and Adobe.

Responsabilités

• Assists with development and IRB submission of research protocol applications and consent forms.
• Assists in protocol writing and obtaining institutional approvals across protocol lifecycle.
• Maintains regulatory documentation and ensures compliance with local, state, federal, and DoW regulations.
• Manages initiation, tracking, and close-out of research protocols; prepares monitoring reports.
• Collects and monitors required training certifications and study personnel documents.
• Performs quality control and source data verification; communicates deviations per SOP and GCP.
• Supports publication clearance for MCCRP manuscripts and presentations; tracks publications.
• Performs other duties as assigned by supervisor.

Connaissances

Regulatory experience

Regulatory knowledge

Technical writing

Organizational skills

Communication skills

Oncology experience

MS Office

Formation

Bachelor's Degree

Outils

MS Word

Excel

PowerPoint

Adobe

Description du poste

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) seeks a Regulatory Affairs Specialist to ensure MCCRP research protocols comply with applicable regulations at local, state, and federal levels.

You will support USUHS and Walter Reed Bethesda with IRB submissions, protocol lifecycle management, and regulatory documentation. Ideal candidates have a Bachelor’s degree and 3–5 years of regulatory experience in research; oncology exposure is a plus.