IRB Regulatory Chair at WIRB-Copernicus Group in Cary, North Carolina

Job Description:

The Regulator Chair at WCG IRB will provide regulatory assistance to clients, the company, the Board, and staff to ensure compliance with governing rules and regulations. This requires knowledge of the federal, state, and international laws, regulations, and guidance, including US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference on Harmonization (ICH) Guidelines.
EDUCATION REQUIREMENTS:

• Bachelor's degree required; or equivalent combination of education and experience


• Juris Doctor or Master's degree preferred

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:

• State Bar Association membership preferred


• Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB. Maintain CIP certification once obtained

QUALIFICATIONS/EXPERIENCE:

• Three years related experience and/or training experience in regulatory affairs or IRB, US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference of Harmonization (ICH) Guidelines, and other applicable regulations desired


• Interpersonal and organizational skills


• Ability to prioritize and address constant deadlines


• Excellent oral and written communication skills


• Ability to work independently and as part of a team


• Computer skills are a must

ESSENTIAL DUTIES/RESPONSIBILITIES:

• BOARD MEETINGS




• Chair Board meetings to ensure compliance with federal and state laws and WCG IRB policies and procedures and facilitate discussion from Board Members. Provide ethical and legal support and advice to 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


• Present training to Board members regarding WCG IRB policies and procedures, federal and state regulations and guidance


• 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


• Review Board meeting minutes to ensure accuracy in the Board's recorded deliberations and compliance with federal regulations


• Identify and assist in the resolution of problematic review items, through interaction with investigators and other IRB clients,


• Perform or assist in performance of expedited review, making appropriate decisions on behalf of the Board, and review of unanticipated problems, research subject complaints involving medical issues, etc.




• CLIENT SUPPORT




• Advise clients of applicable laws and regulations pertaining to human subject research, both orally and in writing


• Analyze requests for exemption determinations and provide formal written opinions that proposed projects are exempt from the requirements for IRB review or do not require IRB review


• Provide guidance to clients to help resolve ethical and regulatory issues and difficulties




• LEGAL RESEARCH


• Research state, federal, and international law and regulations pertaining to human subject safety and research-related issues


• EDUCATION AND TRAINING




• Assist in the development of materials and teach classes for staff preparing for the national Certified IRB Professional (CIP) exam or the internal Advanced Regulatory Training (ART) exam


• Prepare and teach classes to the World Health Organization (WHO) Fellows and the visiting Fellows


• Prepare and deliver training to Board members, outside clients, institutions, and other parties involved in human subject research


• Deliver training to new Board members and new staff including annual Board Training




• OTHER DUTIES




• Consult and advise clients for specific projects per contractual requirements


• Conduct site visits to research sites throughout North America, to assess compliance with WCG IRB policies and the federal regulations. A report must be written for each site visit


• Conduct audits at the request of an institution or client. This requires extensive preparation and a comprehensive written report


• Review literature and other materials to keep abreast of developments in the regulatory, legal, and ethical arenas

ABOUT US:For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human research participants during all phases of clinical trials. Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world. Apply Now