Principal Regulatory Compliance Professional (HS/IRB)

Ripple EffectRegulatory Compliance

This role is fully remote with a preference for local, or within local driving distance to HHS badging locationPart-TimeSenior

Salary59.08 - 67.01 USD per hour

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Job Details

Master's degree in science or relevant fields.
8+ years' relevant experience (additional education substitutes for experience).
2+ years of project management experience.
Demonstrated and substantial experience with Institutional Review Boards (IRBs) and human subjects research programs.
Experience in policy interpretation, implementation, monitoring, and conducting compliance reviews or audits.
Experience reviewing complaints, allegations, incident reports, and corrective action plans.
Knowledge of human research protection programs in academic, healthcare, federal, or research environments.
Intermediate experience with Microsoft Office, Teams, and SharePoint.
Familiarity with electronic IRB management systems and compliance tracking systems.
Exceptional attention to detail and ability to execute instructions.

Serve as a senior subject matter expert supporting OHRP's compliance oversight mission and the protection of human subjects research.
Evaluate compliance with 45 CFR 46 (the Common Rule) and advise OHRP leadership on regulatory, ethical, and operational issues.
Conduct comprehensive reviews of complaints, incident reports, allegations of noncompliance, and IRB regulatory determinations.
Prepare detailed analyses, case summaries, and briefing materials to support leadership decision-making.
Develop and maintain compliance review schedules and proactively address risks to ensure timely reporting.
Perform in-depth analysis of complex compliance cases and evaluate institutional responses and corrective action plans.
Support the implementation of policies and procedures to ensure compliance with evolving laws and regulations.

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