- Job Code: SHR-RA-05T
- Location: Ripple Effect Headquarters - Rockville, MD
- Employee Type: Exempt, Full-Time Regular
- Telework: Client Approved
- Clearance: Public Trust
- Salary Range: $122,895.40 - $139,383.0 per year (how we pay and promote)
Are you passionate about building frameworks that uphold ethics and excellence in human subjects research? Are you energized by solving complex compliance challenges and providing expert guidance on human subjects research protections? Ripple Effect is seeking a
Principal Regulatory Compliance Professional (HS/IRB) to serve as a subject matter expert supporting the
Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this critical role, you will work closely with OHRP leadership to evaluate complex compliance matters involving human subjects research, conduct in-depth reviews of institutional submissions and corrective action plans, and provide expert recommendations on regulatory compliance with the Common Rule (45 CFR 46) and related human research protection requirements.
As a trusted advisor and technical expert, you will assess complaints, incident reports, allegations of noncompliance, and other sensitive matters requiring careful analysis and sound judgment. You will review Institutional Review Board (IRB) records and institutional documentation, support compliance evaluations, and communicate findings and recommendations to senior leadership. Success in this role requires extensive experience in human subjects research oversight, exceptional attention to detail, strong analytical skills, and the ability to clearly communicate complex regulatory issues to diverse stakeholders.
Responsibilities
- Technical Execution: Serves as a senior subject matter expert (SME) supporting OHRP's compliance oversight mission and the protection of human subjects involved in research conducted or supported by HHS. Provides expert analysis and recommendations concerning compliance with 45 CFR 46 (the Common Rule), evaluates allegations of noncompliance, reviews institutional submissions and corrective action plans, and advises OHRP leadership on regulatory, ethical, and operational issues related to human subjects protections. Conduct comprehensive reviews of complaints, incident reports, allegations of noncompliance, unanticipated problems involving risks to subjects or others, and IRB regulatory determinations.
- Communication: Leads cross-functional compliance discussions. Prepare detailed analyses, case summaries, and briefing materials to support leadership decision-making.
- Schedule and Timelines: Develops and maintains compliance review schedules, prepare pre and post review documentation, proactively addressing risks to ensure timely completion and reporting.
- Quality Management: Ensures compliance deliverables meet internal and external quality standards through adherence to QMS and corrective action plans.
- Data Analysis: Perform in-depth analysis of complex compliance cases and develop evidence-based findings and recommendations for OHRP leadership. Evaluate institutional responses, corrective action plans, and supporting documentation to determine adequacy and regulatory compliance. Analyze research oversight documentation and identify deficiencies, inconsistencies, regulatory gaps, or areas requiring remediation.
- Regulatory Compliance: Supports the implementation of policies and procedures to ensure compliance with evolving laws and regulations, and serves as liaison with regulatory agencies.
- Documentation: Oversees the creation and maintenance of compliance documentation, ensuring clarity, and accuracy.
- Problem Solving & Continuous Improvement: Identifies and resolves compliance issues, recommending process improvements based on findings. Participate in policy discussions, working groups, and cross-functional reviews involving compliance and oversight activities. Contribute technical expertise to evaluations, special projects, guidance development, and organizational improvement initiatives.
- Supervision: Operates independently under senior leadership direction, managing performance, training, and resources to ensure consistent, audit-ready compliance outcomes.
- Performs other job-related duties as assigned.
RequirementsMinimum Education and Experience - 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.
Basic Requirements - 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.
- Experience reviewing complaints, allegations, incident reports, corrective action plans, and institutional compliance documentation.
- 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.
- Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.
- Familiarity with electronic IRB management systems and compliance tracking systems.
Skills that Set You Apart - 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
- Intermediate experience with AI tools, including their limitations and risks, and how they can be applied to support regulatory and 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
- Experience with specific content areas aligned to our project work may be required.
BenefitsAt Ripple Effect, we reward our employees for their contributions to our mission. Our comprehensive total rewards package includes competitive pay, exceptional benefits, and a range of programs that support your work/life balance and personalized preferences.
Learn more about our benefits and culture here.
