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IRB Regulatory Chairman

Western IRB


Location:
Puyallup, Washington 98374
Date:
06/19/2017
2017-06-192017-07-19
Job Code:
17075
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Drug Safety
  • Regulatory Affairs
Western IRB
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Job Details

For more than 45 years, Western Institutional Review Board® (WIRB) has been at the forefront of protecting the rights and welfare of human subjects during all phases of clinical trials.  Recognized as the gold standard of human subject protection, WIRB 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 distinguished staff of full-time physicians, Certified IRB Professionals, lawyers, and research professionals delivers unparalleled review quality to ensure that human research studies withstand scrutiny around the world.

We're looking for dynamic and motivated professional to join our mission of protecting human research subjects as our IRB Regulatory Chairman at our Puyallup Washington location. 

Along with a competitive salary, we also provide a robust benefits package (medical, dental, vision, PTO, 401K and more). 

Position Summary:

In this position, you will provide regulatory assistance to clients, the company, the Board, and staff to ensure compliance with governing rules and regulations. 

Essential Duties & Responsibilities:

  • Chair Board meetings to ensure compliance with federal and state laws and Company policies and procedures.  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.
  • 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.

Requirements

Education Requirements: 

  • Juris Doctor or Master’s degree 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
  • Knowledge of MS Word, MS Excel, MS Outlook and MS Windows.

We encourage you to visit us at www.wcgclinical.com to learn more about our organization, and WIRB-Copernicus Group’s mission of improving the quality of human health.