Regulatory Coordinator - MA

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

Jun 20, 2025 - 21:20

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