Senior Regulatory Analyst (HS/IRB) (Full-Time)

• Job Code: SHR-RA-04T
• Location: Ripple Effect Headquarters - Rockville, MD
• Employee Type: Exempt, Full-Time Regular
• Telework: Client Approved
• Clearance: Public Trust
• Salary Range: $1024,13,02 - $117,774.98 per year (how we pay and promote)

Are you passionate about bridging science and strategy to drive progress forward? Are you interested in helping ensure that human subjects research is conducted ethically and in compliance with federal regulations?

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. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators. Additionally, you will apply your knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements to identify potential issues, support compliance reviews, and help 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.

Responsibilities

• Technical Execution: Be the first point of contact for communications between internal and external parties. Receive and review complaints and incident report documents for completeness, accuracy, potential participant safety concerns, and regulatory significance

• Communication and Documentation: Provide preliminary assessment for complaints and incident reports to agency leadership. Draft correspondence, information requests, case summaries, briefing materials, and status reports. Communicate professionally with research institutions, IRB personnel, investigators, complainants, and government officials. Request and collect additional information necessary to support compliance evaluations. Present analyses and recommendations to supervisors and compliance review teams. Participate in internal case review meetings and support leadership reporting activities, Develops a wide range of deliverables including reports, communication logs, trackers, briefing decks, and training materials, ensuring clarity and consistency.

• Schedule and Timelines: Track case status, milestones, correspondence, and required follow-up activities. Ensure records management practices support transparency, quality assurance, and audit readiness.

• Quality Management: Ensures deliverables meet quality standards and guidelines for format, content, and accessibility, and contributes to continuous improvement efforts.
• Regulatory Compliance and Data Analysis: Applies working knowledge of regulatory and contractual requirements and contributes to content development and compliance procedures for the agency, Assist in monitoring and communicating institutional corrective actions and resolution of compliance matters, Analyze research documentation, IRB records, investigator information, institutional responses
• Problem Solving & Continuous Improvement: Contributes to new processes and procedures to enhance team effectiveness and efficiency and proposes solutions to complex issues.
• Supervision: Works under general direction, executes assignments independently, and keeps supervisor updated.

• Performs other job-related duties as assigned.

Requirements

Minimum Education and Experience

• 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.

Basic 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

At 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.