ObjectiveHealth

Compliance

• Coordinate and participate in regulatory research activities for all sites across ObjectiveHealth
• Prepare, review, manage, track, file, and submit study-specific regulatory and training documents
• Maintain delegation of authority and training logs, CVs, licenses, training certificates, and physician credentials
• Ensure compliance with IRB-approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws
• Follow up on pending signatures and missing documentation
• Collaborate with internal teams, research staff, investigators, and external sponsors to resolve issues
• Prepare IRB submissions, including initial protocols, amendments, and safety updates
• Review and edit Informed Consent Forms for regulatory and protocol compliance
• Participate in study start-up, monitoring visits, audits, and regulatory inspections
• Maintain current knowledge of clinical research regulations, GCP, and FDA/ICH guidance
• Provide regulatory training to site staff as needed

Regulatory Specialist