IRB Regulatory Analyst (Part-Time) — Compliance & Review

Socket.dev

Detroit (MI)

On-site

USD 34,000 - 55,000

Part time

3 days ago
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Job summary

Wayne State University invites applications for an Institutional Review Board (IRB) Regulatory Analyst, Part-Time, 2nd Available Position on the Detroit campus. The role provides expert regulatory analysis of minimal-risk submissions and supports timely IRB determinations.

The position requires a Master’s degree and 3–4 years’ experience with human participant research, FDA/OHRP/DoD regulations, and strong communication with investigators and study teams.

Qualifications

  • Master’s degree in a relevant field.
  • 3–4 years’ job-related experience.
  • Experience with human participant research.
  • Knowledge of FDA, OHRP, DoD regulations and AAHRPP standards.
  • Ability to communicate with investigators and staff.

Responsibilities

  • Conduct expert regulatory and institutional review of minimal-risk submissions, including initial minimal risk submissions, expedited amendments, and expedited continuing reviews.
  • Evaluate IRB submission materials for completeness, accuracy, consistency, and regulatory appropriateness.
  • Communicate with IRB staff, investigators, and study teams to resolve review issues and provide guidance on IRB requirements.
  • Prepare and maintain accurate review of documentation, determinations, correspondence, and records to support timely 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
Regulatory analysis
Regulatory compliance
Communication skills

Education

Master’s degree

Job description

Wayne State University invites applications for an Institutional Review Board (IRB) Regulatory Analyst, Part-Time, 2nd Available Position on the Detroit campus. The role provides expert regulatory analysis of minimal-risk submissions and supports timely IRB determinations.

The position requires a Master’s degree and 3–4 years’ experience with human participant research, FDA/OHRP/DoD regulations, and strong communication with investigators and study teams.

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