Institutional Review Board Manager - FT - Days - MHS - On-Site

Coordinates the day-to-day activities of the Institutional Review Board (IRB) office, including review of research protocols for regulatory compliance, protocol review management, and assistance with the meetings of the Board. Reviews submitted applications, makes the final compliance determinations and approval decisions.

Responsibilities

Coordinates the day-to-day activities of the Institutional Review Board (IRB) office, including review of research protocols for regulatory compliance, protocol review management, and assistance with the meetings of the Board; Reviews submitted applications, makes the final compliance determinations and approval decisions; Assists and performs additional tasks related to day-to-day operations of the IRB office as assigned by the IRB Director; Serves as the alternate voting member for the IRB Director and moderates IRB meetings, as needed; Drafts and distributes agenda and materials to the IRB members ahead of meetings along with official meeting minutes after the meeting; Summarizes any controverted issues, their resolution and the Board's action; Generates IRB correspondence related to action items and outcomes on each submission; Serves as a subject matter expert and maintains up-to-date knowledge on DHHS and FDA regulations related to protections of human subjects in research; Assists the IRB Director with revisions to institutional policies and procedures; Maintains advanced knowledge of the electronic IRB submission system and future upgrades; Assists with the system set up and revisions of application forms and templates; Conducts reviews of complex scientific research protocols to ensure compliance with DHHS and FDA regulations; Determines applicable review types, identifies regulatory and ethical issues and facilitates revisions to the submissions; Makes final outcome determinations for submissions and communicates them to the IRB Director, Board Members, and study staff

Requirements

Masters (Required); Certified IRB Professional (CIP) - Collaborative Institutional Training Initiative (CITI); Five (5) years of experience working in an IRB office or as a reviewer of human subject research for regulatory compliance; Master's degree in a research or science related field; Critical thinking skills; Effective communication; Decisive judgment; Ability to build and foster positive relationships; Ability to lead others and take appropriate action when required