Regulatory Coordinator - MA

Job Summary

A company is looking for a Regulatory Coordinator - GI Oncology.

Key Responsibilities

• Prepare and submit all protocol applications, amendments, and informed consent documents for review and approval
• Track and manage assigned new protocol start-up packets and ensure all start-up activities are completed
• Establish and maintain communication with study teams and regulatory agencies to ensure required information is relayed

Required Qualifications

• Bachelor's Degree required
• Experience in a medical or scientific research setting preferred
• Fundamental knowledge of clinical trial conduct preferred
• Knowledge of ICH/GCP, FDA policies, and the IRB submission process
• Proficiency in Microsoft applications and databases required