IRB Reliance — Quality Improvement Intake Lead

Nemours is seeking an IRB Reliance/Quality Improvement Intake Lead to join our team, based in Wilmington, DE.

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.
o Initiate and negotiate reliance agreements with external IRBs, ensuring all necessary details are included.
o Track the status of all reliance agreements, including renewal dates.
o Monitor compliance with the terms of reliance agreements.
+ Protocol Review and Submission:
o Review research protocols submitted for sIRB to ensure completeness and compliance with relevant regulations, laws, HRPP local considerations, and institutional policies.
o 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.
o Facilitate communication between the institution's investigators and the reviewing and relying IRBs.
+ Compliance Oversight:
o Stay updated on current HRPP regulations, laws, guidelines, and best practices related to single IRB reliance.
o Conduct periodic reviews of reliance processes to identify potential areas for improvement.
o Address any concerns raised by the reviewing IRB regarding study conduct at the institution's sites.
o Apply knowledge of federal, state, ...