IRB Reliance & QA Program Lead

University of Notre Dame; Notre Dame (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

The University of Notre Dame seeks an IRB Reliance and Quality Assurance Program Coordinator to support the Human Research Protection Program by coordinating IRB activities related to protocol review, reliance agreements, and post-approval monitoring.

In this role you will guide investigators, research staff, and IRB members on federal regulations and institutional policies, manage external reliance relationships, and help ensure compliant, ethical research across the campus.

Qualifications

• Bachelor’s degree is required.
• Experience supporting IRB activities or human subjects research administration is required.
• Excellent written and verbal communication skills are essential.
• Ability to convey complex regulatory information to investigators and staff.
• Strong organizational skills and attention to detail are required.

Responsibilities

• Coordinate daily administration of IRB reliance activities and post-approval monitoring.
• Serve as primary resource for investigators and IRB members regarding IRB processes and policies.
• Guide investigators during protocol submission, amendments, continuing reviews, and reportable events.
• Coordinate reliance agreements with external institutions, including sIRB arrangements.
• Conduct administrative reviews to ensure completeness and compliance before IRB review.
• Maintain regulatory records in eRA systems and communicate regulatory guidance.

Skills

Excellent communication

Strong organizational skills

Independent and collaborative work

Customer service & relationship skills

Ability to explain regulatory concepts

Education

Bachelor's degree

Life sciences/healthcare/public health degree

Tools

Microsoft Office Suite

eRA systems

Job description

The University of Notre Dame seeks an IRB Reliance and Quality Assurance Program Coordinator to support the Human Research Protection Program by coordinating IRB activities related to protocol review, reliance agreements, and post-approval monitoring.

In this role you will guide investigators, research staff, and IRB members on federal regulations and institutional policies, manage external reliance relationships, and help ensure compliant, ethical research across the campus.