Compliance Analyst

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

📋 Description

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

• Receive and evaluate complaints and incident reports for thoroughness, precision, participant safety issues, and regulatory importance.

• Provide initial assessments of complaints and incident reports to agency management.

• Draft various documents, including correspondence, information requests, case summaries, briefing materials, status reports, communication logs, trackers, briefing decks, and training resources.

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

• Solicit and gather additional information for compliance assessments.

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

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

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

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

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

• Apply regulatory and contractual requirements to compliance processes.

• Monitor and communicate institutional corrective measures and compliance resolutions.

• Analyze research documents, IRB records, investigator information, and institutional responses.

• Contribute to improvements in processes and solutions for complex challenges.

• Work autonomously under general supervision and keep the supervisor informed.

• Undertake other job-related tasks as assigned.

⛳️ Requirements

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

• Over 4 years of relevant experience; additional education can substitute for experience.

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

• Experience reviewing or supporting compliance activities concerning human subjects research.

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

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

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

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

• Ability to manage sensitive information and maintain detailed records accurately.

• Basic knowledge of project management tools such as Microsoft Planner, Microsoft Project, Asana, and Smartsheet.

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

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

• Certifications in project management, CIP, CCRP, CHRC, or related research compliance credentials are recommended.

• Foundational knowledge in technical writing for process documentation, briefing decks, status reports, memos, and business writing.

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

• 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

• A diverse and stimulating work environment.

• Opportunities to contribute to a significant public health mission.

• Flexible work arrangements that accommodate your lifestyle and career development.

• Competitive salary.

• Comprehensive benefits package.

• Programs that promote work/life balance and cater to personal preferences.