Senior Regulatory Analyst – HS/IRB

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Act as the initial point of contact for communications between both internal and external stakeholders.

• Receive and assess complaints and incident reports to ensure completeness, accuracy, participant safety concerns, and regulatory importance.

• Provide preliminary evaluations to agency leadership.

• Compose correspondence, information requests, case summaries, briefing materials, and status updates.

• Engage with research institutions, IRB personnel, investigators, complainants, and government representatives.

• Request and gather information for compliance assessments.

• Present analyses and recommendations to supervisors and compliance review teams.

• Participate in internal case review meetings and assist in leadership reporting.

• Develop reports, communication logs, trackers, briefing decks, and training materials.

• Monitor case status, milestones, correspondence, and follow-up activities.

• Maintain records that support transparency, quality assurance, and audit readiness.

• Ensure deliverables adhere to quality, format, content, and accessibility standards.

• Oversee and communicate institutional corrective actions and compliance resolutions.

• Analyze research documentation, IRB records, investigator details, and institutional responses.

• Contribute to processes and procedures that enhance team effectiveness and efficiency.

• Execute tasks independently under general supervision while keeping the supervisor informed.

• Carry out other job-related responsibilities as assigned.

⛳️ Requirements

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

• 8+ years of relevant experience; additional education can substitute for experience.

• Experience related to the protection of human subjects in research and regulatory compliance.

• Experience reviewing or assisting with compliance activities associated with human subjects research.

• Experience collaborating with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight bodies.

• Knowledge of federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).

• Experience evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.

• Experience preparing written analyses, regulatory summaries, reports, or compliance correspondence.

• Experience handling sensitive information and accurately maintaining detailed records.

• Basic familiarity with project management software such as Microsoft Planner, Microsoft Project, Asana, and Smartsheet.

• Exceptional attention to detail, ability to follow instructions, and dedication to quality and compliance.

• Intermediate proficiency with Microsoft Office productivity software and collaboration tools like Microsoft Teams and SharePoint.

• Advanced degree is preferred.

• Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credentials are recommended.

• Foundational knowledge of technical writing.

• Basic understanding of AI tools, including their limitations, risks, and applications in 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.

• Public Trust clearance.

🏝️ Benefits

• Competitive salary.

• Outstanding benefits.

• Flexible work options that accommodate your lifestyle and support professional development.

• Significant opportunities to contribute to an essential public health mission.