POST-APPROVAL MONITOR 1

LSU; New Orleans (LA); Sur place; USD 60 000 - 80 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clinical research coordination

Quality assurance

Audit/CAPA

Formation

Bachelor's degree

Description du poste

Title: POST-APPROVAL MONITOR 1 Employee Type: Unclassified Staff Department: VCAA-Institutional Review Boar Campus Location: VICE CHANCELLOR/ACADEMIC AFFAI

Job Summary/Basic Functions

The Post-Approval Monitor (PAM) supports the LSUHSC-NO Human Research Protection Program by conducting routine and for-cause monitoring of IRB-approved human subjects research to verify that studies are conducted in accordance with the approved protocol, applicable federal regulations (45 CFR 46, 21 CFR 50/56/312/812), institutional policy, and Good Clinical Practice (GCP) standards. The PAM operates as an independent quality assurance and quality improvement (QA/QI) function within Research Compliance, complementing — rather than duplicating — the IRB's initial and continuing review responsibilities. The position is central to demonstrating institutional oversight capacity in support of AAHRPP accreditation and to identifying compliance risks before they result in reportable events, sponsor findings, or regulatory action.

Minimum Qualifications Required

Education: Bachelor's Required Field of Study: Public Health, Biological Sciences, Health Care Administration, Nursing, Business Administration, Research Administration, or related field

Number of years required to perform the job: 2

Type of experience required to perform the job: Clinical research, IRB/HRPP administration, clinical research coordination, research compliance, quality assurance, or audit/CAPA-related work

Substitution: Master's or PhD can substitute 2 years of experience