General Information

Location: Cary, NC, Puyallup, WA

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements


An opportunity to make a difference!


Here at WCG IRB, we are seeking a Regulatory Chair to join our team. As a Regulatory Chair, you will be providing 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


Please note: At this time, we are only seeking candidates who live within a commutable distance to our offices in Cary, NC (preferred) or Puyallup, WA

EDUCATION REQUIREMENTS:

  • Bachelor’s degree required, or equivalent combination of education and experience
  • Advanced degree preferred (Juris Doctor, Master's degree, or nursing)

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: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.


BOARD MEETINGS

  • Chair Board meetings to ensure compliance with federal and state laws and WIRB 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 weekly training to Board members regarding WIRB 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 WCG IRB 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

COVID-19 Vaccination

Please note that, to be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date

Not only will you learn and grow in this role, but you will enjoy the rewards of being a WCG IRB team member, including:

  • Being a part of a collaborative team in a mission-driven organization
  • Robust medical, dental, and vision plans within 30 days of employment
  • Up to 20 PTO days and 12 paid holidays annually
  • Matching 401K program
  • Tuition reimbursement
  • Much, much more!!!

Interested? Please apply today and one of our Talent associates will be in touch

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