CenterWatch

1+ months

IRB Regulatory Chairperson

WIRB-Copernicus Group (WCG)
Puyallup, WA 98371

General Information

Location: Puyallup, WA

Organization: Western Inst. Review Board

Job Type: Full Time

Description and Requirements

We're looking for dynamic and motivated professional to join our mission of protecting human research subjects as our IRB Regulatory Board Chairperson at our Puyallup Washington location.  In this role, you will provide regulatory and ethical reviews of clinical research study, discuss your findings with other professionals and draft summaries for clients.  If youre interested in the advancement of clinical studies throughout the globe, we would welcome you to our team.  We will gladly provide exceptional training to skilled professionals.  

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

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 Boards 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: 

  • Bachelors degree required and three years relatable experience and/or training; or equivalent combination of education and experience.

  • Juris Doctor or Masters degree is preferred. 

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.

About Western IRB

For more than 50 years, Western Institutional Review Board (WIRB), a member of the WIRB-Copernicus Group family, 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.


Categories

Posted: 2019-06-14 Expires: 2019-09-16

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IRB Regulatory Chairperson

WIRB-Copernicus Group (WCG)
Puyallup, WA 98371

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