Clinical Research Regulatory Specialist

Job Summary

A company is looking for a Clinical Research Regulatory Specialist.

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, generates regulatory data reports, and ensures compliance with federal regulations and ICH/GCP

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 is highly preferred
• Knowledge of GCP/ICH guidelines is required
• Proficiency with Microsoft applications and electronic health records
• Ability to work independently and handle sensitive information in compliance with HIPAA guidelines