Principal Regulatory Compliance Specialist

Job Summary

To support the Office for Human Research Protections (OHRP), the part-time Principal Regulatory Compliance Specialist will serve as a subject matter expert, evaluating compliance matters in human subjects research, conducting reviews of institutional submissions, and providing recommendations on regulatory compliance while working remotely.

Key responsibilities

• Serve as a senior subject matter expert supporting OHRP's compliance oversight mission and providing expert analysis on regulatory compliance with the Common Rule
• Lead cross-functional compliance discussions and prepare detailed analyses and briefing materials for leadership decision-making
• Develop and maintain compliance review schedules, ensuring timely completion and adherence to quality standards

Required qualifications

• Master's degree in science or relevant fields
• 8+ years of relevant experience, with 2+ years in project management
• Demonstrated experience with Institutional Review Boards (IRBs) and human subjects research compliance
• Intermediate experience with Microsoft Office and collaboration tools like Microsoft Teams and SharePoint
• Familiarity with electronic IRB management systems and compliance tracking systems