IRB Reliance and QA Program Coordinator

University of Notre Dame • Notre Dame, IN

5d • $100,000

About The Position

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.

Requirements

• Bachelor's degree required.
• 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.

Nice To Haves

• Degree in life sciences, biomedical sciences, healthcare, public health, research administration, or a related discipline preferred.
• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level