Clinical Research Regulatory Specialist

Job Summary

To support a growing clinical research organization, the full-time Clinical Research Regulatory Specialist will manage regulatory compliance and documentation, maintain communication with the IRB, and ensure adherence to GCP and SOP guidelines while working remotely.

Key Responsibilities

• Maintains and organizes regulatory documents for monitoring and auditing research studies
• Facilitates communication with the IRB and assists with regulatory filings and clinical trial support documents
• Tracks sponsor and IRB approvals, ensuring compliance with federal regulations and ICH/GCP standards

Required Qualifications

• Bachelor's degree and a minimum of 2 years of experience in clinical research, or equivalent education and experience
• 1+ years of regulatory experience preferred; knowledge of GCP/ICH guidelines required
• Proficiency in Microsoft applications and electronic health records
• Strong organizational skills and ability to manage multiple tasks effectively
• Ability to handle sensitive information in compliance with HIPAA guidelines