General Information

Location: Cary, NC

Organization: The Copernicus Group, Inc.

Job Type: Full Time - Regular

Description and Requirements

We're looking for dynamic and motivated professional to join our mission of protecting human research subjects as our IRB Board Vice-Chairperson.  In this role, you will Assist in leading IRB Board to ensure thorough, ethical and consistent review of each protocol and related study information.  This position is also required to conduct Expedited Reviews in accordance with company policy.

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

Essential Duties & Responsibilities:

  • Assist in leading the IRB Board including Board Member consultants and work closely with Operations Leader to ensure Board is conducting thorough and ethical reviews.

  • Provide regulatory guidance for study related issues as they pertain to the IRB’s determinations and applicable federal regulations.

  • Assist staff with external communications including but not limited to deferral/disapproval letters, FDA and OHRP correspondence and Client considerations when warranted.

  • Conduct expedited review of study related documents and modifications after thorough review of materials in accordance with company policy.

  • Communicate with appropriate teams on any issues, follow up, client and subject needs or Board changes.

  • Follow up with clients to meet conditions placed on studies at the Board meetings.

  • Create and Review internal SOP’s and other policies related to the human research protection program.

  • Organize, develop and lead training and continuing education of Board members.

  • Be available for interviews during client and regulatory audits.

  • Guide and direct Safety staff in review of unanticipated problems involving increased risks to subjects and policies relating to the management and dissemination of safety information for CGIRB reviewed studies.

  • Review and assess site visit reports by QA/RC department of CGIRB-approved research sites to determine compliance with all applicable regulations, company policies and procedures and Board conditions.

  • Provide guidance and review of subject and third-party contact reports.

  • Review approved CGIRB Board meeting minutes. 

  • Participate as a member of the company’s internal Human Research Protection Program [HRPP].

Education Requirements: 

  • A Juris Doctorate, Medical Doctor, or other advanced degree (Masters or PhD level) in an applicable discipline and equivalent related experience required

Qualifications/Experience Requirements:

  • A minimum of 7 years’ experience in clinical research or 5 years in an IRB setting with evidence of increasing responsibility. 

  • Must have experience serving on an IRB Board for at least 4 consecutive years. Prior experience as an IRB chair or vice chair preferred. 

  • Knowledge of FDA Code of Federal Regulations (21 CFR Parts 11, 50, 56, 312, and 812 and 814), HHS regulations (45 CFR 46 and 164) and ICH Guidelines required. 

  • Must be conversant with applicable regulations and industry standards governing clinical research. 

  • Excellent verbal/written communication and presentation skills needed and possess extreme attention to detail. 

  • Prior managerial experience demonstrating leadership expertise required.

  • Must have advanced skills in Microsoft Word, Excel, Outlook and Access, and PowerPoint presentations. 

  • Ability to multi-task, work in stressful situations, meet strict deadlines and work independently required.

About US

WCG (WIRB-Copernicus Group) is the world's leading provider of solutions that measurably improve the quality and efficiency of clinical research. The industry's first clinical services organization (CSO), WCG enables biopharmaceutical companies, CROs, and institutions to accelerate the delivery of new treatments and therapies to patients, while maintaining the highest standards of human subject protections.