Part-Time IRB Regulatory Analyst: Research Compliance

Socket.dev; Detroit (MI); On-site; USD 41,000 - 69,000; Part time

Job summary

Wayne State University in Detroit, MI, is seeking an experienced Institutional Review Board (IRB) Regulatory Analyst, Part-Time, to ensure compliance for human participant research activities. The role covers expedited reviews, amendments, and initial submissions, with regular interaction with investigators and study teams.

The position requires a Master’s degree and 3–4 years of related experience in IRB submission evaluation, research compliance, and regulatory affairs.

Qualifications

• Master’s degree from an accredited college or university in health, bioethics, health sciences, social sciences, regulatory affairs, research administration, public administration, or related field preferred.
• 3–4 years’ job-related experience in review of research involving human participants is expected.

Responsibilities

• Conduct expert regulatory and institutional review and analysis of minimal-risk research submissions, including initial minimal risk submissions, expedited amendments, and expedited continuing reviews.
• Evaluate IRB submission materials for completeness, accuracy, consistency, and regulatory appropriateness; identify needed revisions or clarifications.
• Communicate with IRB Administration staff, investigators, and study teams to resolve review issues and provide guidance regarding IRB requirements.
• Prepare and maintain accurate review of documentation, determinations, correspondence, and records to support timely and consistent IRB decisions.
• Support compliance with federal regulations, institutional policies, ethical standards, and accreditation requirements through consistent application of IRB procedures. Maintain current knowledge of human participant protection requirements.
• Perform other duties as assigned.

Skills

IRB regulations

FDA/OHRP regulations

Regulatory analysis

Research administration

Communication skills

Education

Master’s degree

Job description

Wayne State University in Detroit, MI, is seeking an experienced Institutional Review Board (IRB) Regulatory Analyst, Part-Time, to ensure compliance for human participant research activities. The role covers expedited reviews, amendments, and initial submissions, with regular interaction with investigators and study teams.

The position requires a Master’s degree and 3–4 years of related experience in IRB submission evaluation, research compliance, and regulatory affairs.