IRB Reliance and QA Program Coordinator

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

Company Description

The University of Notre Dame is more than a workplace; it is a vibrant, mission-driven community where every employee is valued and supported. Rooted in a tradition of excellence and inspired by our Catholic character, Notre Dame is committed to fostering an environment of care that nurtures the whole person—mind, body, and spirit. Here, you will find a deep sense of belonging, a culture that prioritizes well-being, and the opportunity to grow your career while being a force for good in the world. Whether contributing to world-class research, shaping the student experience, or supporting the University’s mission in other ways, you will be part of a dedicated team working to make a meaningful impact on campus and beyond. At Notre Dame, your work matters, and so do you!

Job Description

The IRB Reliance and Quality Assurance Program Coordinator supports the University’s Human Research Protection Program (HRPP) by coordinating Institutional Review Board (IRB) activities related to protocol review, reliance agreements, and post-approval monitoring. This position serves as a resource to investigators, research staff, IRB members, and institutional stakeholders by providing guidance on federal regulations, ethical standards, institutional policies, and IRB procedures governing human subjects research.

The coordinator facilitates the review and administration of research protocols, manages reliance relationships with external institutions, and supports the University’s Human Subjects Post-Approval Monitoring Program to promote compliance with federal regulations, institutional policies, and IRB determinations. Working collaboratively with investigators, research administration offices, and IRB leadership, this position helps ensure the efficient administration of the Human Research Protection Program while safeguarding the rights and welfare of research participants.

This position is structured as a career progression opportunity. Applicants at varying stages of their careers are encouraged to apply. Placement at Level I, II, or III will be determined based on education, experience, professional certifications, and demonstrated expertise.

Key responsibilities

• Coordinate the daily administration of IRB reliance activities, quality assurance initiatives, and post-approval monitoring within the Human Research Protection Program.
• Serve as a primary resource for investigators, research staff, IRB members, and institutional partners regarding IRB processes, reliance agreements, regulatory requirements, and institutional policies.
• Provide guidance to investigators during the preparation and submission of new protocols, amendments, continuing reviews, reportable events, and study closures.
• Coordinate and administer reliance agreements with external institutions, including single IRB (sIRB) arrangements and collaborative research activities.
• Conduct administrative reviews of research submissions to ensure completeness and compliance prior to IRB review.
• Coordinate post-approval monitoring activities to evaluate ongoing compliance with approved protocols, federal regulations, and institutional requirements.
• Review monitoring findings, communicate recommendations to investigators, and assist with corrective action planning when appropriate.
• Maintain accurate regulatory records and documentation within electronic research administration (eRA) systems.
• Interpret and communicate federal regulations, ethical principles, and institutional policies related to human subjects research.
• Collaborate with IRB leadership to identify opportunities for operational improvements and enhanced customer service.
• Assist with the development and delivery of educational materials, training programs, and outreach initiatives related to IRB compliance and reliance processes.
• Support quality assurance activities designed to strengthen the Human Research Protection Program.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree required.
• Degree in life sciences, biomedical sciences, healthcare, public health, research administration, or a related discipline preferred.
• 2+ years of experience supporting Institutional Review Board (IRB) activities or human subjects research administration required.
• Excellent written and verbal communication skills.
• Ability to communicate complex regulatory information to investigators, faculty, staff, and external collaborators.
• Strong organizational skills with exceptional attention to detail.
• Ability to prioritize multiple responsibilities while meeting deadlines.
• Demonstrated customer service and relationship-building skills.
• Ability to learn and effectively utilize electronic research administration (eRA) systems and other web-based applications.
• Proficiency with Microsoft Office Suite or comparable productivity software.
• Ability to interpret policies and regulations, exercise sound judgment, and resolve issues in accordance with established procedures.
• Ability to work both independently and collaboratively in a team environment.

Preferred qualifications

• Experience supporting Human Research Protection Programs (HRPP) or Institutional Review Boards (IRB) within higher education, healthcare, or research institutions.
• Experience coordinating reliance agreements or serving as a single IRB (sIRB) liaison.
• Familiarity with post-approval monitoring, quality assurance, and compliance auditing activities.
• Working knowledge of federal regulations governing human subjects research, including the Common Rule and FDA regulations.
• Experience with electronic IRB or electronic research administration (eRA) systems.
• Certified IRB Professional (CIP) or eligibility to obtain certification.

Additional Information

Salary up to $100,000; commensurate with experience.

The University of Notre Dame seeks to attract, develop, and retain the highest quality faculty, staff and administration. The University is an Equal Opportunity Employer, and does not discriminate on the basis of race, color, national or ethnic origin, sex, disability, veteran status, genetic information, or age in employment. Moreover, Notre Dame prohibits discrimination against veterans or disabled qualified individuals, and complies with 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a). We strongly encourage applications from candidates attracted to a university with a Catholic identity.

• Division: Vice President of Research
• Job Subfamily: Research Integrity - RE005
• Unit: NDRAC - Rsch Integrity & Compliance - 43103
• Career Stream / Level: EIC2
• Job Family: Research