Location: Manhasset, NY
Cap-Exempt H-1B Position — No lottery required
This individual will manage all IRB reviews under the auspices of the Northwell Health Research Intelligence Institutional Review Board (IRB) and will oversee all IRB responsibilities related to newly implemented clinical research for Northwell. Additionally, this individual will review nonclinical trial, expedited or exempt research, as needed. The incumbent will specialize in concepts associated with FDA regulations and the research protocol review and submission process to ensure compliance with local, state, and federal regulations and guidance. The IRB analyst will assist researchers, staff, and other stakeholders with drafting and editing protocols and consent forms and interprets regulations when analyzing research submissions to identify research requirements. Conducting in-depth pre-reviews and drafting meeting minutes will be required. This individual provides feedback to investigators and research staff to guide them in making necessary modifications to submissions in order to meet applicable institutional, regulatory, and other requirements for obtaining approval and maintaining compliance with committee guidance. Job Responsibility - Analyzes, verifies, tracks and performs preliminary administrative review of items referred to IRB and communicates deficiencies or questions to investigators; assists in preparation of reports and correspondence related to IRB activities. - Reviews proposed research for compliance with federal, state and local regulations; determines category of review and assess risk; evaluates need for further clinical or professional review of research. - Provides support to investigators by assuring the accuracy of submissions and modifications; responds to investigators regarding deficiencies, inconsistencies or concerns. - Monitors continuing review of research for compliance; identifies and reports items of concern for further action. - Maintains accurate records, including database management; provides assistance in the performance