IRB Reliance and QA Program Coordinator

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ND Energy

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2005

⚡ Energy

📚 Education

🔬 Science

Energy • Education • Science

ND Energy is a University of Notre Dame research and engagement center focused on energy research, policy, and technology that advances sustainable and equitable energy transitions. It convenes faculty, students, and external partners to develop interdisciplinary solutions, inform policy and ethical decision-making, and translate research into community and global impact through education, outreach, and applied projects.

📋 Description

• 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 during 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 arrangements and collaborative research activities. • Conduct administrative reviews of research submissions for completeness and compliance before IRB review. • Coordinate post-approval monitoring activities and evaluate ongoing compliance. • Review monitoring findings, communicate recommendations, and assist with corrective action planning. • Maintain regulatory records and documentation in electronic research administration systems. • Interpret and communicate federal regulations, ethical principles, and institutional policies related to human subjects research. • Collaborate with IRB leadership on operational improvements and customer service. • Assist with educational materials, training programs, and outreach initiatives related to IRB compliance and reliance processes. • Support quality assurance activities for the Human Research Protection Program. • Perform other duties as assigned.

🎯 Requirements

• 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 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 and exceptional attention to detail. • Ability to prioritize multiple responsibilities while meeting deadlines. • Demonstrated customer service and relationship-building skills. • Ability to learn and effectively use electronic research administration 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 according to established procedures. • Ability to work independently and collaboratively in a team environment. • Preferred: experience supporting Human Research Protection Programs or IRBs within higher education, healthcare, or research institutions. • Preferred: experience coordinating reliance agreements or serving as a single IRB liaison. • Preferred: familiarity with post-approval monitoring, quality assurance, and compliance auditing. • Preferred: working knowledge of the Common Rule and FDA regulations. • Preferred: experience with electronic IRB or electronic research administration systems. • Certified IRB Professional certification or eligibility to obtain certification preferred. • Cover letter and resume required.

🏖️ Benefits

• Remote work option • Career growth opportunity through placement at Level I, II, or III • Equal employment opportunity and nondiscrimination protections • Opportunity to work in a mission-driven, well-being-focused university community