Senior Human Subjects Compliance Lead (Remote)

Ripple Effect; Rockville (MD); On-site; USD 81,000 - 92,000; Part time

Job summary

Ripple Effect is seeking a Principal Regulatory Compliance Professional to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services.

You will evaluate complex compliance matters in human subjects research and provide expert recommendations on the Common Rule (45 CFR 46). You will review IRB records, assess complaints and corrective actions, and communicate findings to senior leadership.

Qualifications

• Demonstrated IRB and human subjects oversight experience.
• Experience reviewing complaints, incidents, and corrective action plans.
• Knowledge of human research protection programs in academic, healthcare, federal, or research environments.
• Strong attention to detail and ability to communicate regulatory issues clearly.

Responsibilities

• Technical Execution: SME supporting OHRP's compliance oversight and 45 CFR 46.
• Communication: Lead cross-functional compliance discussions and prepare briefing materials.
• Schedule and Timelines: Develop compliance review schedules and document pre/post reviews.
• Quality Management: Ensure deliverables meet quality standards per QMS and corrective action plans.
• Data Analysis: Analyze complex compliance cases and develop findings for leadership.
• Documentation: Oversee creation and maintenance of compliance documentation.

Skills

IRB experience

Human subjects research

Policy interpretation

Policy implementation

Compliance reviews

Investigations

Audits

AI tools

Education

Master's degree in science or relevant fields

Tools

Microsoft Office

Teams

SharePoint

AI tools

Job description

Ripple Effect is seeking a Principal Regulatory Compliance Professional to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services.

You will evaluate complex compliance matters in human subjects research and provide expert recommendations on the Common Rule (45 CFR 46). You will review IRB records, assess complaints and corrective actions, and communicate findings to senior leadership.