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, institutional departments, and regulatory bodies
• Maintain research files and documentation in compliance with regulatory requirements

Required Qualifications, Training, and Education

• 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
• Experience in clinical research compliance and/or regulatory research is preferred
• Knowledge of FDA regulations and ICH and GCP guidelines is preferred
• Experience using electronic data submission software is preferred