IRB Human Protections Coordintor
Position Highlights Department: Cancer Center Hours: 32 per week Shift: Shift 1 - Days Position Summary The IRB Administrator / Human Protections Administrator oversees the administrative and regulatory operations of the Institutional Review Board (IRB) to ensure the protection of human research participants and compliance with federal, state, and institutional requirements. This role serves as the primary regulatory resource for investigators, IRB members, and research staff regarding ethical and compliant conduct of human subjects research. Responsibilities Manage all administrative operations of the IRB office and maintain IRB records, agendas, minutes, correspondence, and historical files. Conduct administrative and regulatory review of research submissions, including protocols, amendments, continuing reviews, consent documents, and safety reports. Determine appropriate review categories (exempt, expedited, or full board) in accordance with federal regulations and institutional policies. Coordinate and support IRB meetings, serving as an advisory and voting member when appropriate. Provide guidance and education to investigators, research staff, and IRB members regarding human subjects protections, HIPAA, ethical standards, and applicable regulations. Ensure compliance with federal regulations including 45 CFR 46, 21 CFR 50, 21 CFR 56, GCP, and ICH guidelines. Prepare approval letters, regulatory correspondence, and federally required documentation, including maintenance of the organization's Federalwide Assurance (FWA). Serve as the primary contact for internal and external audits, regulatory inspections, and compliance inquiries. Monitor regulatory changes and recommend updates to institutional policies and procedures. Assist with investigations of non-compliance, protocol deviations, and research-related regulatory concerns. Minimum Qualifications Bachelor's degree in a healthcare, science, regulatory, or related field or equivalent experience required. 1–3 years of experience in human subjects research oversight, IRB administration, or clinical research compliance preferred. Working knowledge of medical terminology and human research protection regulations. Strong organizational, analytical, communication, and problem-solving skills. Demonstrated ability to work independently and effectively collaborate with investigators, administrators, and regulatory agencies. Preferred Qualifications Certified IRB Professional (CIP) certification or eligibility to obtain within 12 months. Comprehensive Benefits Offered Competitive and affordable benefits package Shift Differentials Continuing Education assistance Tuition reimbursement Student Loan relief through Fiducius Quick commute access from I-84, Route 9 and surrounding areas About Middlesex Health The Smarter Choice for your Career! Come join one of Connecticut's Top Workplaces, and a Magnet designated organization! At Middlesex Health, we have a unique combination of award-winning talent, world-class technology, and patient-first care that's making health care better. Through our affiliation with the Mayo Clinic Care Network, Middlesex Health has access to the most advanced medical knowledge and research available.
