Nemours is seeking an IRB Reliance/Quality Improvement Intake Lead to join our team.

The IRB Reliance Lead:

is responsible for overseeing and managing all aspects of an institution's \"reliance\" process, which involves coordinating with external Institutional Review Boards (IRBs) to review research studies conducted at multiple sites, ensuring human research protection program compliance with federal regulations and local institutional policies, facilitating the establishment and maintenance of reliance agreements between the institution and other IRBs, , maintaining records of such reliance, and monitoring the quality and efficiency of the reliance process.

Quality Review Committee Intake Manager:

is responsible for overseeing the initial intake process for potential quality improvement projects within Nemours, on behalf of the Quality Review Committee (QRC). The responsibilities include ensuring that proposed projects align with strategic goals, meet necessary criteria, and are properly documented before moving into the implementation phase; this includes evaluating the feasibility, potential impact, and resource requirements of each proposed project while coordinating with stakeholders across different departments to facilitate a smooth intake process. Further responsibilities include tracking collection of progress reports and facilitating close-out activities.

Job Duties Include:

• Triaging data and biospecimen registries as well as maintaining documentation of these activities.
• Reliance Agreement Management:
  • Identify research protocols that require reliance on an external IRB and studies where another site is relying on Nemours.
    • Initiate and negotiate reliance agreements with external IRBs, ensuring all necessary details are included.
    • Track the status of all reliance agreements, including renewal dates.
    • Monitor compliance with the terms of reliance agreements.
  • Protocol Review and Submission:
    • Review research protocols submitted for sIRB to ensure completeness and compliance with relevant regulations, laws, HRPP local considerations, and institutional policies.
    • Coordinate the submission of protocol documents to the reviewing IRB on behalf of the institution's investigators or to the Nemours IRB for studies where Nemours is the IRB of record.
    • Facilitate communication between the institution's investigators and the reviewing and relying IRBs.
  • Compliance Oversight:
    • Stay updated on current HRPP regulations, laws, guidelines, and best practices related to single IRB reliance.
    • Conduct periodic reviews of reliance processes to identify potential areas for improvement.
    • Address any concerns raised by the reviewing IRB regarding study conduct at the institution's sites.
    • Apply knowledge of federal, state, and local regulations and laws as necessary, and university policies and practices, to ensure that IRB reliance arrangements are in compliance.
  • Education and Training:
    • Provide training and guidance to researchers on the reliance process, including how to identify when reliance is necessary, what their responsibilities are as a relying site, a lead site, and how to properly submit protocols for review.
    • Educate IRB members on reliance procedures and relevant regulations when acting as an sIRB.
  • Collaboration:
    • Work closely with the IRB office staff, research administrators, and investigators to facilitate the reliance process.
    • Establish and maintain relationships with other institutions' IRB offices to streamline reliance agreements.
    • Maintain and regularly update a registry of collaborative activities (Research, QA, QI) with reliance agreements across the enterprise.
  • Quality Improvement Project Intake and Screening:
    • Receive and review proposals for new quality improvement research projects from clinicians, staff, or other departments.
    • Identifying projects that do not meet quality improvement guidelines and need to be submitted to the Institutional Review Board for a Research Determination.
    • Assess project feasibility, alignment with organizational priorities, and potential impact on patient care.
    • Evaluate proposed research methodologies, data collection strategies, and analysis plans.
    • Identify potential ethical considerations and compliance issues with relevant regulations.
    • Secure progress reports
    • Share related resources
• Other duties as assigned.

Requirements:

• Bachelor's Degree required.
• Minimum five (5) years of experience required.
• Experience with IRB systems required.
• Knowledge of IRB regulations and guidelines required.
• Must have strong communication, negotiation, organizational, detail oriented, and analytical skills.
• Proficiency in MS Office products (Teams, PowerPoint, Word, Excel, and Outlook).
• Certified IRB Professional (CIP) obtained within five (5) years of hire.
• Certified Professional Healthcare Quality (CPHQ) obtained within five (5) years of hire.