Clinical Research Regulatory Specialist

Job Summary

To support a growing clinical research organization, the full-time Clinical Research Regulatory Specialist will ensure regulatory compliance and documentation, maintain communication with the IRB, and oversee quality control in a fully remote environment.

Key Responsibilities

• Maintains organized regulatory documents and ensures readiness for audits and regulatory filings
• Facilitates communication with the IRB and assists with the development of clinical trial support documents
• Tracks sponsor and IRB approvals, generates regulatory data reports, and assists in training programs as needed

Required Qualifications

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