Principal Regulatory Compliance Professional – HS/IRB

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

📋 Description

• Act as a senior subject matter expert assisting OHRP in its mission to oversee compliance and safeguard human subjects in research conducted or supported by HHS.

• Analyze and offer recommendations related to adherence to 45 CFR 46 (the Common Rule).

• Assess reports of noncompliance.

• Review submissions from institutions, corrective action plans, complaints, incident reports, unanticipated issues, and IRB regulatory determinations.

• Provide guidance to OHRP leadership on regulatory, ethical, and operational issues concerning human subjects protection.

• Facilitate compliance discussions across various functions.

• Prepare analyses, case summaries, and briefing documents for leadership's decision-making process.

• Create and maintain schedules for compliance reviews along with pre- and post-review documentation.

• Ensure that deliverables meet both internal and external quality standards through QMS and corrective action plans.

• Assess institutional responses and the adequacy of supporting documentation to ensure regulatory compliance.

• Identify deficiencies, inconsistencies, regulatory gaps, and areas needing remediation.

• Support the development of policies and procedures in line with evolving laws and regulations while coordinating with regulatory agencies.

• Supervise compliance documentation for clarity and accuracy.

• Address compliance issues and propose process enhancements.

• Engage in policy discussions, collaborate in working groups, participate in cross-functional reviews, special projects, guidance formulation, and initiatives aimed at organizational improvement.

• Work independently under the direction of senior leadership, managing performance, training, and resources to ensure compliance outcomes are audit-ready.

• Carry out other job-related tasks as assigned.

⛳️ Requirements

• Master’s degree in science or a related field.

• Over 8 years of relevant experience; additional education may substitute for experience.

• At least 2 years of project management experience.

• Background in science, public health, or research through education or experience.

• Significant experience with Institutional Review Boards (IRBs), human subjects research programs, policy interpretation, policy execution and monitoring, as well as compliance reviews, investigations, audits, evaluations, or regulatory assessments.

• Proven experience in reviewing complaints, allegations, incident reports, corrective action plans, and institutional compliance documentation.

• Understanding of human research protection programs within academic, healthcare, federal, or research settings.

• Intermediate proficiency in Microsoft Office, Microsoft Teams, and SharePoint.

• Exceptional attention to detail with a demonstrated ability to follow instructions accurately.

• Familiarity with electronic IRB management and compliance tracking systems.

• Certification in relevant regulatory areas, such as CIP, is recommended.

• Intermediate experience with AI tools, including their limitations and risks, and their application in regulatory and compliance contexts.

• Experience with federal agencies, academic medical centers, research institutions, or healthcare systems involved in human subjects research.

• Background in government contracting.

• Specific expertise aligned with project work may be necessary.

• Public Trust clearance.

🏝️ Benefits

• Competitive salary.

• Outstanding benefits.

• Flexible work arrangements.

• Meaningful opportunities to contribute to significant public health missions.

• Opportunities for professional development.

• Support for work/life balance.

• Customized benefits and culture programs.