Oversees the technical and administrative review and auditing functions of the New England Baptist Hospital IRB by providing professional direction and oversight of program operations and assisting in the education of faculty, staff and administration in biomedical research. Coordinates IRB activities with other offices and compliance committees and represents the IRB with collaborating institutions, research sponsors and regulatory agencies. Develops and implements policies and procedures for ensuring compliance with federal, state and local regulations governing the protection of human subjects. Serves as a primary resource of regulatory and ethical advice for IRB members, investigators and institutional officials.
Principal Duties and Essential Functions:
Develops and maintains annually the Human Research Protection Program and IRB Standard Operating Procedures and Policies with the Institutional Office and the IRB Chair in compliance with federal, state and institutional regulations and policies.
Serves as Human Protections Administrator on the Federal Wide Assurance with the U.S. Office of Human Research Protections; Updates the FWA and IRB registrations.
In conjunction with the IRB Chair and Institutional Office, reviews and maintains existing or future IRB Authorization Agreements and prepares and assists with any IRB FDA audits.
Directs the Research Education and Compliance and Quality Assurance Programs by conducting routine audits on studies with the approval of the IRB or as requested by the IRB or Institutional Office.
Monitors investigator compliance and reports noncompliance as appropriate in conjunction with the IRB Chair and Institutional Official; assists with specific inquiries and/or IRB-related non-compliance issues as requested by the IRB or Institutional Office
Oversees, coordinates and provides leadership in review of research proposals, expedited proposals, and requests for emergency use of investigational projects as requested by the IRB Chair.
Represents the human subject compliance programs to various groups and committees; administers the Human Subjects Training Program Collaborative Institutional Training Initiative
Provides on-going education to IRB members and community members and maintains training certification;
Develops and maintains the IRB research compliance documentation and reporting systems, including the electronic IRBNet submissions program and IRBNet Library, and all associates files and records as required; oversees IRB billing
Administers the Fellows Research Program; assists the Clinical Research Coordinator Manager with educating staff regarding Human Subjects Protections, Good Policy Practices and other regulatory education; attends Division meetings and assists with management of annual events and projects.
Bachelor’s Degree Required. Master’s Degree Preferred. Healthcare concentration preferred.
Must have CITI certification or capability of becoming certified within a short period of time
Human Subjects Protection Required.
Required Work Experience:
5 years research experience required. IRBnet experience required. IRBnet Library required
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