California Regulatory Coordinator

Job Summary

A company is looking for a Regulatory Coordinator who will support the regulatory and compliance processes of clinical research.

Key Responsibilities

• Prepare and submit protocols and supporting documents to regulatory bodies and agencies
• Respond to inquiries from sponsors and regulatory bodies, and maintain research documentation
• Ensure compliance with Good Clinical Practice (GCP) guidelines and HIPAA regulations

Required Qualifications

• 1 year of experience in healthcare, clinical research, or a related field
• Bachelor's Degree in a related field or equivalent combination of education and experience
• Preferred experience in clinical research compliance and regulatory submissions
• Knowledge of FDA regulations and ICH guidelines
• Experience with electronic data submission software is preferred