Regulatory Affairs Specialist

$64,200 - $87,000/Yr

The Henry M. Jackson Foundation For The Advancement Of Military Medicine - Bethesda, MD

Full-time - Mid Level

Bethesda, MD

Hospitals

About the position

The Regulatory Affairs Specialist at the Henry M. Jackson Foundation for the Advancement of Military Medicine plays a crucial role in ensuring compliance with local, state, and federal regulations for human subjects research and related protocols. This position supports the John P. Murtha Cancer Center Research Program by assisting in the development and submission of research protocols, maintaining regulatory compliance, and facilitating communication between various stakeholders in the research process.

Responsibilities

• Assist with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms.
• Participate in protocol writing and obtaining required institutional approvals.
• Ensure timely submission of protocol amendments, continuing reviews, and adverse events to the IRB.
• Maintain study compliance with established regulations for human subjects' research.
• Keep complete and accurate regulatory-compliant program/study binders.
• Assist with initiation, tracking, management, and close-out of research studies.
• Complete monitoring reports and follow-up letters, summarizing significant findings and suggesting compliance actions.
• Collect and monitor required research training certifications for investigators and study team members.
• Perform quality control and verification of research source documentation against case report form data.
• Assist with the institutional publication clearance process for MCCRP manuscripts and presentations.

Requirements

• Bachelor's Degree is required.
• Minimum of 3-5 years of experience in regulatory affairs or related field.
• Basic knowledge of human subjects' research regulations.
• Experience working on regulatory items for research protocols.
• Excellent writing skills to explain scientific and technical ideas clearly.
• Strong organizational and time management skills.
• Excellent communication and interpersonal skills.
• Oncology experience is a plus.
• Proficiency with MS Word, Excel, PowerPoint, and Adobe.

Nice-to-haves

• Experience in oncology research.
• Familiarity with Good Clinical Practices (GCP).

Benefits

• Dental insurance
• Health insurance
• Retirement plan
• Vision insurance