Clinical Research Regulatory Coordinator

Job Summary

To support a clinical research network, the full-time Clinical Research Regulatory Coordinator will provide centralized regulatory support, manage regulatory documentation, coordinate IRB submissions, and conduct quality reviews, primarily in a hybrid work environment.

Key responsibilities

• Prepare and assemble study start-up regulatory packages and manage site activation activities
• Coordinate and submit IRB applications, amendments, and ensure compliance with approval requirements
• Conduct centralized quality reviews of regulatory files and maintain inspection-ready documentation throughout the study lifecycle

Required qualifications

• Associate's Degree required; Bachelor's Degree in Life Sciences or related field preferred
• Minimum 2 years of clinical research regulatory experience required
• Experience preparing IRB submissions and supporting study start-up activities required
• Strong knowledge of ICH-GCP guidelines and FDA regulations
• Proficiency in electronic regulatory systems, preferably REALTIME CTMS