[Hiring] Senior Regulatory Analyst @Ripple Effect

Role Description

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP's compliance oversight mission by:

• Reviewing complaints, incident reports, and institutional submissions related to human subjects research.
• Assisting with the evaluation of compliance matters and conducting preliminary assessments.
• Reviewing regulatory documentation and supporting case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators.
• Applying knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements.
• Identifying potential issues, supporting compliance reviews, and helping develop recommendations for leadership consideration.

Strong attention to detail, analytical thinking, and written communication skills are essential as you help maintain accurate records, prepare reports, and support the protection of research participants across a diverse research landscape.

Qualifications

• Master's degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.
• 8+ years relevant experience; additional education substitutes for experience.

Requirements

• Demonstrated experience related to human subjects research protections and regulatory compliance including:
• Reviewing or supporting compliance activities related to human subjects research.
• Working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations.
• Applying federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).
• Evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
• Preparing written analyses, regulatory summaries, reports, or compliance correspondence.
• Managing sensitive information and maintaining detailed records with a high degree of accuracy.
• Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana, and Smartsheet.
• Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.
• Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.

Skills that Set You Apart

• Advanced degree preferred.
• Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended.
• Foundational knowledge of technical writing in areas including process documentation, briefing decks, status reports, memos, and other business writing.
• Basic knowledge of AI tools, including their limitations and risks, and how they can be applied to support project management tasks.
• Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations.
• Familiarity with electronic compliance or case management systems and document management tools.

Benefits

• Competitive pay.
• Exceptional benefits.
• A range of programs that support your work/life balance and personalized preferences.