California Licensed Regulatory Coordinator

Job Summary

To ensure compliance with regulatory requirements, the full-time California Licensed Regulatory Coordinator will prepare and submit protocols and supporting documents to various regulatory bodies while working remotely from approved states.

Key responsibilities

• Prepares and submits regulatory documents and maintains compliance with institutional policies and federal regulations
• Responds to inquiries from regulatory bodies and generates necessary reports to comply with requirements
• Collaborates with clinical trial coordinators and research staff to ensure all regulatory documents are current and accurate

Required qualifications

• Bachelor's Degree
• Minimum of 3 years of experience in clinical research regulatory affairs
• Experience with preparing and submitting regulatory documents, managing IRB and/or IACUC submissions
• Knowledge of FDA, GCP, and HIPAA compliance standards
• Authorization to work and reside in one of the approved states for remote employment