Clinical Research Regulatory Coordinator

Job Summary

To support a growing clinical research network, the part-time Clinical Research Regulatory Coordinator will manage regulatory documentation, coordinate IRB submissions, and conduct quality reviews while working remotely on a contracted basis.

Key responsibilities

• Prepare and assemble study start-up regulatory packages and manage IRB submissions
• Conduct centralized quality reviews of regulatory files and ensure compliance with regulations
• Serve as a regulatory resource for research sites, addressing questions and supporting sponsor communications

Required qualifications

• Associate's Degree required; Bachelor's Degree in a related field preferred
• Minimum 2 years of clinical research regulatory experience required
• Experience preparing IRB submissions and supporting study start-up activities required
• Familiarity with REALTIME CTMS and eRegulatory modules strongly preferred
• Strong knowledge of ICH-GCP guidelines and FDA regulations