California Licensed Regulatory Coordinator

Job Summary

To support clinical research compliance, the full-time California Licensed Regulatory Coordinator will prepare and submit protocols to regulatory bodies, respond to inquiries from sponsors and departments, and maintain documentation while working remotely from California.

Key responsibilities

• Prepare and submit research protocols and supporting documents to regulatory bodies
• Respond to questions from sponsors and institutional departments regarding regulatory compliance
• Maintain research files and documentation in accordance with 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
• Knowledge of FDA regulations and ICH guidelines
• Experience in submitting documents to regulatory bodies
• Familiarity with electronic data submission software