Senior Human Subjects Compliance Leader (IRB/HS)

Ripple Effect; Rockville (MD); On-site; USD 123,000 - 139,000; Full time

Job summary

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

This senior role evaluates complex compliance matters, reviews IRB records, and provides expert regulatory recommendations. Responsibilities include leading cross-functional discussions, developing schedules, and ensuring audit-ready documentation while advancing ethical human subjects research

Qualifications

• Master's degree in science or relevant fields.
• 8+ years' relevant experience, additional education substitutes for experience.
• 2+ years of project management experience.
• Education or experience in science, public health or research is required.
• Demonstrated and substantial experience with Institutional Review Boards (IRBs), human subjects research programs, policy interpretation, policy implementation & monitoring, and conducting compliance reviews, investigations, audits, evaluations, or regulatory assessments
• Knowledge of human research protection programs in academic, healthcare, federal, or research environments
• Intermedia experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.
• Familiarity with electronic IRB management systems and compliance tracking systems
• Advanced degree in public health, bioethics, law, regulatory affairs, clinical research, health policy, life sciences, or a related field
• Certification in relevant regulatory areas including CIP recommended
• Experience with AI tools and their limitations and risks for regulatory/compliance activities
• Experience working with federal agencies, academic medical centers, research institutions, or healthcare systems with work involving human subjects research
• Experience with government contracting

Responsibilities

• Technical Execution: SME supporting OHRP's compliance oversight, evaluates 45 CFR 46, reviews submissions and corrective actions.
• Communication: Leads cross-functional compliance discussions and prepares analyses and briefing materials.
• Schedule and Timelines: Develops compliance review schedules and ensures timely completion and reporting.
• Quality Management: Ensures deliverables meet quality standards through corrective action plans.
• Data Analysis: Performs in-depth analysis of complex compliance cases and supporting documentation.
• Regulatory Compliance: Supports policy implementation to ensure compliance with evolving laws.
• Documentation: Oversees creation and maintenance of compliance documentation.
• Problem Solving & Continuous Improvement: Identifies issues and recommends process improvements.
• Supervision: Manages performance, training, and resources for audit-ready outcomes.
• Performs other job-related duties as assigned.

Skills

IRB oversight

Regulatory compliance

Data analysis

Communication

Policy interpretation

Project management

Attention to detail

AI tools awareness

Education

Master's degree in science or relevant fields

Education or experience in science, public health or research

Tools

Microsoft Office

Microsoft Teams

SharePoint

Job description

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

This senior role evaluates complex compliance matters, reviews IRB records, and provides expert regulatory recommendations. Responsibilities include leading cross-functional discussions, developing schedules, and ensuring audit-ready documentation while advancing ethical human subjects research