Senior Regulatory Analyst (HS/IRB) – Remote

Ripple Effect; Rockville (MD); On-site; USD 102,000 - 118,000; Full time

Job summary

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

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.
• 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.

Responsibilities

• Be the first point of contact for communications between internal and external parties.
• 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.
• Track case status, milestones, correspondence, and required follow-up activities.
• Ensure records management practices support transparency, quality assurance, and audit readiness
• 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
• Contributes to new processes and procedures to enhance team effectiveness and efficiency and proposes solutions to complex issues.
• Works under general direction, executes assignments independently, and keeps supervisor updated.
• Performs other job-related duties as assigned.

Skills

Attention to detail

Regulatory compliance knowledge

Communication skills

Education

Master's degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field

Tools

Microsoft Planner

Microsoft Project

Asana

Smartsheet

SharePoint

Microsoft Teams

Job 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. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support