Post-Approval Research Compliance Monitor

Bering-Alaka'ina Holdings, LLC; Silver Spring (MD); On-site; USD 88,000 - 99,000; Full time

Benefits offered by this job

401K with company match

Medical insurance

Paid time off

Tuition reimbursement

11 paid holidays

Job summary

Bering-Alaka`ina Holdings, LLC seeks a Post Approval Compliance Monitor to support HSPB and government customers in Maryland. Responsibilities include developing monitoring plans, performing regulatory file reviews, and delivering training to investigators and staff to assure IRB and DoD compliance.

The role requires a bachelor’s degree in a life sciences field and at least two years in clinical research monitoring or regulatory compliance, with strong writing and timeframe discipline.

Qualifications

• Bachelor’s degree in a relevant field (Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology OR related life sciences).
• Minimum two (2) years of clinical research monitoring or regulatory compliance experience.
• Experience with monitoring visits, audits, or post‑approval reviews of human subjects research.

Responsibilities

• Develop and implement monitoring plans for WRAIR and forward labs.
• Conduct routine and for‑cause monitoring of protocols and IRB requirements.
• Draft monitoring reports and provide timely feedback to COR/HSPB.
• Maintain weekly regulatory file reviews and ensure accuracy and compliance.
• Provide training on human subjects protection and monitoring best practices.

Skills

IRB operations

Regulatory compliance

Reporting and documentation

Time management

Training delivery

FDA regulations knowledge

Education

Bachelor’s degree in Biomedical Science, Public Health, Clinical Research, Regulatory Affairs, Psychology, Biology, or related life sciences

Tools

ACRP Certification

SOCRA Certification

Job description

Bering-Alaka`ina Holdings, LLC seeks a Post Approval Compliance Monitor to support HSPB and government customers in Maryland. Responsibilities include developing monitoring plans, performing regulatory file reviews, and delivering training to investigators and staff to assure IRB and DoD compliance.

The role requires a bachelor’s degree in a life sciences field and at least two years in clinical research monitoring or regulatory compliance, with strong writing and timeframe discipline.