California Licensed Regulatory Coordinator

Job Summary

A company is looking for a Regulatory Coordinator Sr.

Key Responsibilities

• Prepare and submit protocols and supporting documents to regulatory bodies and agencies
• Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines and HIPAA regulations
• Generate reports and maintain research files and documentation required for clinical trials

Required Qualifications

• 3 years of experience in healthcare, clinical research, or a related field
• Prior regulatory experience with document submissions to regulatory bodies
• Bachelor's Degree in a related field or equivalent combination of education and experience
• Proficient knowledge of FDA regulations and ICH guidelines is preferred
• Experience with electronic data submission software is preferred