Principal Regulatory Compliance Professional (HS/IRB) (Part-Time)

- Job Code: SHR-RA-05T
- Location:   Ripple Effect Headquarters – Rockville, MD   
- Employee Type:  Exempt, Part-Time Regular
- Telework: Full-time (this role is fully remote with a preference for local, or within local driving distance to HHS badging location)
- Clearance:  Public Trust
- Salary Range:  $59.08-$67.01 per hour (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 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.

If you are a collaborative problem-solver with deep expertise in human subjects research protections and a commitment to advancing ethical research practices, there's a place for you here at Ripple Effect . We offer a diverse and engaging work environment, meaningful opportunities to support important public health missions, and flexible work options that support your lifestyle and professional growth.

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 c