IRB Post-Approval QA & Compliance Monitor

LSU; New Orleans (LA); On-site; USD 60,000 - 80,000; Full time

Job summary

LSU is seeking a Post-Approval Monitor 1 to support the Human Research Protection Program by monitoring IRB-approved studies for protocol and regulatory compliance. The role emphasizes independent QA/QI activities within Research Compliance, helping safeguard AAHRPP accreditation.

The candidate will work to identify compliance risks before they lead to reportable findings or regulatory actions, contributing to institutional oversight capacity.

Qualifications

• Education: Bachelor's degree required; fields include Public Health, Biological Sciences, Health Care Administration, Nursing, Business Administration, or related.
• Minimum experience: 2 years in clinical research, IRB/HRPP administration, or related QA/audit roles.
• Substitution: Master's or PhD can substitute 2 years of experience.

Responsibilities

• Conduct routine and for-cause monitoring of IRB-approved studies to verify protocol compliance.
• Ensure activities align with 45 CFR 46, 21 CFR 50/56/312/812 and GCP standards.
• Support AAHRPP accreditation efforts and identify compliance risks before findings occur.

Skills

Clinical research coordination

Quality assurance

Audit/CAPA

Education

Bachelor's degree

Job description

LSU is seeking a Post-Approval Monitor 1 to support the Human Research Protection Program by monitoring IRB-approved studies for protocol and regulatory compliance. The role emphasizes independent QA/QI activities within Research Compliance, helping safeguard AAHRPP accreditation.

The candidate will work to identify compliance risks before they lead to reportable findings or regulatory actions, contributing to institutional oversight capacity.