California Licensed Regulatory Coordinator

Job Summary

A company is looking for a Senior Regulatory Coordinator (Clinical Research).

Key Responsibilities

• Manage regulatory submissions and ensure compliance with applicable regulations and institutional policies
• Track and maintain regulatory documents, including IRB compliance and correspondence
• Write and submit research correspondence to IRB and study sponsors

Required Qualifications

• Bachelor's degree
• 3+ years of experience as a Regulatory Coordinator/Specialist in clinical research
• Knowledge of FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• Experience with Institutional Review Board (IRB) policies and procedures
• Experience in writing research correspondence and submitting regulatory documents