Post Approval Compliance Monitor

Bering-Alaka`ina Holdings (BAH) is looking for a Post Approval Compliance Monitor to provide support for our government customer in Silver Springs, Maryland.

The Post Approval Compliance Monitor supports the WRAIR Human Subjects Protection Branch (HSPB) by conducting routine and forcause monitoring of human subjects research to ensure compliance with federal regulations, DoD policies, institutional requirements, and approved study documents. This role is responsible for developing and executing monitoring plans, performing regulatory file reviews, documenting compliance findings, and providing training to research teams and institutional stakeholders.

The Compliance Monitor plays a critical role in ensuring research quality, subject safety, and continuous institutional compliance.

• DESCRIPTION OF RESPONSIBILITIES:

Monitoring Program Development

• Develop a comprehensive monitoring plan for WRAIR and its forward laboratories in accordance with applicable SOPs.
• Deliver the initial monitoring plan within three months of task order award; update the plan annually.
• Ensure deliverables meet deadlines at least 95% of the time, coordinating with the COR for any exceptions.

Routine and For Cause Monitoring

• Conduct routine and forcause monitoring of human subjects research protocols and activities requiring research determinations.
• Confirm appropriate regulations, policies, and IRB requirements are applied during protocol review and execution.
• Validate that studies are conducted in accordance with IRB approvals, institutional policies, and federal/DoD regulations.
• Complete time sensitive monitoring visits within the timeframe specified by the COR, maintaining a 95% ontime completion rate.

Reporting and Documentation

• Draft clear, accurate monitoring reports describing activities performed, findings identified, and corrective actions necessary.
• Provide draft reports to the COR and/or HSPB Director within ten business days of each visit.
• Incorporate feedback promptly to finalize deliverables within required timelines.

Regulatory File Reviews

• Conduct weekly internal reviews of electronic and hardcopy HSPB files to ensure accuracy, completeness, and regulatory compliance.
• Update or correct files within five business days of identifying an issue.
• Maintain compliance with allowable delays: up to three delays per year for weekly reviews and up to three for required updates.

Training and Education

• Provide training to investigators, research staff, IRB members, and HSPB personnel on human subjects protection, compliance monitoring, and regulatory file quality.
• Support development of training materials, presentations, and job aids related to research compliance and monitoring best practices.
• Other duties as assigned by Supervisor.

Bachelor's degree in a relevant field such as Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology, or related life science disciplines.

• Minimum two (2) years of experience in clinical research monitoring, human subjects research oversight, IRB operations, or regulatory compliance.
• Demonstrated experience performing monitoring visits, audits, or postapproval reviews of human subjects research.
• Experience preparing clear, detailed compliance or monitoring reports.
• Ability to track and meet multiple deadlines consistently.
• Experience presenting training or education on research compliance topics.
• Excellent understanding of FDA regulations relating to human subjects protections, ethical research principles, and compliance practices.
• Strong analytical and document review skills with high attention to detail.
• Ability to work independently, manage multiple priorities, and maintain strict timelines.
• Skilled in presenting regulatory requirements and compliance expectations in a clear and approachable manner.
• Strong writing skills for developing professional reports and guidance materials.

• Minimum three to five (3-5) years of experience in human subjects research oversight, clinical research monitoring, IRB operations, or regulatory compliance.
• Master's degree (MPH, MS Clinical Research, Regulatory Affairs, Bioethics, etc.)
• Hold a monitoring certification (ACRP, SOCRA)
• Experience in a DoD research setting, preferably with WRAIR or similar military medical research organizations.
• Experience conducting forcause compliance investigations.
• Familiarity with ICHGCP and international research compliance standards.
• Experience…