Nemours is looking for an Associate Director of Nemours Office of Human Subjects Protection. This position is responsible for assuring effective functioning of the assigned Institutional Review Board or Boards including pre-meeting, in-meeting, and post-meeting research review activities as required by applicable law, regulation, and Nemours policy and procedure. This position reports to the Nemours Office of Human Subject Protection (NOHSP) Director and is designed to assist and support the Director in his/her functions as well as to take primary responsibility for the educational and continuous improvement aspects of NOHSP. Under the guidance of the NOHSP Director, the Associate Director has the responsibility of overseeing day-to-day Nemours Office of Human Subject Protection (HSP) operations, and provides HSP program leadership, expert knowledge, education and training, and other assistance for the two Nemours Institutional Review Boards (IRBs), research teams, research support units, and study participants. The Associate Director provides significant leadership in continuous improvement activities related to human subject protection within the Nemours enterprise, primarily through the AAHRPP accreditation process. The incumbent promotes the protection of human participants involved in research as a core value throughout the Nemours enterprise and within the communities served by Nemours.
This is a remote position.
Primary Responsibilities:
Serves as an ethical and regulatory subject matter expert on the Nemours human research protection program (HRPP) throughout the enterprise, providing consultation, advice, interpretation of policy, and recommendations to investigators and research teams, IRB members, study participants, and other research support units within Nemours such as research administration, radiation safety, biosafety, office of sponsored projects, compliance, and research integrity.
In coordination with the Director NOHSP, identifies areas for continuous improvement in Nemours human subject protections and uses QI tools, such as the PDCA cycle and AAHRPP accreditation processes, to drive improvement.
Monitors and facilitates Nemours human subject research (HSR) protocols through the regulatory human subject review process, coordinating with other research support units to ensure efficiency, consistency, and high-quality processes of research review and approval for the ultimate protection of human subjects participating in Nemours research activities.
Reviews and approves Exempt and Expedited HSR protocols; independently reviews and edits minutes of IRB meetings to ensure compliance and appropriate documentation per OHRP, FDA, and AAHRPP regulations and standards; and works with IRB coordinators to ensure accurate documentation and correspondence related to IRB deliberations.
In collaboration with the Director of NOHSP, reviews and analyzes new guidelines, policies, regulations, and other human subject protection information from federal, state, local, accrediting, and Nemours entities for applicability to current NOHSP policies, procedures, and practices.
Assists the Director NOHSP with the creation, implementation, monitoring, and refinement of the systems, policies, procedures, online/electronic protocol procedures, educational outreach, and accreditation efforts undertaken in support of the Nemours HRPP and in response to changes in the regulatory environment.
Plans and implements the NOHSP education plans for IRB members, researchers, and their teams, and other Nemours associates, students, and trainees concerning human subjects protection in response to changing regulations, evolving ethical understanding, and changing needs of the organization; participates in orientation, process, and the remedial training (as a result of audit or suspension) as needed.
Assists the Director in overseeing NOHSP staff in the daily coordination of, and education/training in, the protocol submission and review process, assisting the NOHSP Director with performance appraisals, hiring, and payroll as needed.
Identifies content areas for print and online communications, such as the research newsletter, NOHSP TeamShare, and the Nemours NOHSP website, and develops or provides additional or revised content as needed.
Provides support for special projects as assigned by the NOHSP Director.
Submit the annual AAHRPP Report and the Re-accreditation materials every 5 years.
Provides IRB member education at monthly meetings.
Must have a minimum of 5 years of regulatory experience in a healthcare organization required (preferably 10 years of experience); Institutional Review Board (IRB) administration experience preferred
