IRB Regulatory Chair

Essential Duties & Responsibilities: Chair Board meetings to ensure compliance with federal and state laws and Company policies and procedures. Provide ethical and legal support and advice to Board members Facilitate discussion from Board Members. Assist in resolution of disagreements between Board members. Analyze and present protocols and other agenda items at Board meetings to facilitate informed decision making, and to set standards and role model effective presentation and discussion for all Board members. Analyze research submissions, identify problems and issues, collect additional information or request corrections, and draft memoranda. Research, draft, and present reports to the Board on a wide range of topics, including but not limited to, investigator misconduct, site visits, FDA and sponsor audits of investigators and others, issues involving human subjects, sponsors, and institutions. Convey the Board’s concerns with the research submission by composing written correspondence to investigators and sponsors. This may include requesting additional information and providing the rationale for required changes. Identify and assist in the resolution of problematic review items, through interaction with investigators and other IRB clients. Advise clients of applicable laws and regulations pertaining to human subject research, both orally and in writing. Provide guidance to help resolve ethical and regulatory issues and difficulties. Research state, federal, and international law and regulations pertaining to human subject safety and research-related issues. Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas.

Education Requirements: Juris Doctor or Master’s degree in a related field is preferred. Bachelor’s degree required and three years related experience and/or training; or equivalent combination of education and experience. Qualifications/

Experience Requirements: Experience in regulatory affairs or IRB, US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference of Harmonisation (ICH) Guidelines, and other applicable regulations desired. Able to Chair Board meeting. Can effectively present information to a diverse group of professionals Must not have been debarred or declared ineligible by any state or federal agency from participating in clinical research. Knowledge of MS Word, MS Excel, MS Outlook and MS Windows.