Senior Regulatory Analyst; HS​/IRB

Senior Regulatory Analyst (HS/IRB)

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.

If this position sounds of interest, there's a place for you here at Ripple Effect! We offer a diverse and engaging work environment, meaningful opportunities to support an important public health mission, and flexible work options that support your lifestyle and professional growth.

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.