Clinical Research Regulatory Coordinator

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