IRB Regulatory Chair

HireHive; Puyallup (WA); On-site; USD 100,000 - 160,000; Full time

Job summary

HireHive in Washington state seeks a regulatory affairs professional to provide guidance to clients, the Board, and staff, ensuring compliance with governing rules and regulations.

The role emphasizes advising on FDA processes, CFR guidelines, GCP, and IRB procedures, including drafting memoranda, reports, and formal correspondence to investigators and sponsors.

Qualifications

• Experience in regulatory affairs or IRB, US GCP, CFR Titles 21 and 45, and ICH guidelines.
• Able to chair Board meetings and present information to a diverse group of professionals.
• Must not have been debarred or ineligible to participate in clinical research.
• Knowledge of MS Word, MS Excel, MS Outlook and MS Windows.

Responsibilities

• Chair Board meetings to ensure compliance with federal and state laws and Company policies.
• Provide ethical and legal support and advice to Board members.
• Facilitate discussion from Board Members and assist in resolution of disagreements.
• Analyze and present protocols and other agenda items at Board meetings to facilitate informed decision making.
• Analyze research submissions, identify problems, collect information, and draft memoranda.
• Research, draft, and present Board reports on topics including FDA audits and human subjects issues.
• Convey Board concerns by composing written correspondence to investigators and sponsors.
• Identify and assist in resolution of problematic review items with investigators and IRB clients.
• Advise clients on applicable laws and regulations pertaining to human subject research.
• Research state, federal, and international law and regulations pertaining to human subject safety.
• Review literature to stay abreast of regulatory developments.

Skills

Regulatory affairs

IRB

Good Clinical Practice

CFR Titles 21 & 45

ICH Guidelines

Regulatory research

Education

Juris Doctor (JD)

Master’s degree in a related field

Bachelor’s degree

Tools

MS Word

MS Excel

MS Outlook

MS Windows

Job description

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.
• 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 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.

Education Requirements:

• Juris Doctor or Master’s degree in a related field is 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
• 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.