South Carolina Regulatory Coordinator

Job Summary

Serving as the Regulatory Coordinator for the Clinical Trial Research Program in Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology, and Hepatology, the full-time position will manage study-specific regulatory processes, ensure compliance with regulations and SOPs, and coordinate with Clinical Research Coordinators and the Program Manager, all while working remotely.

Key responsibilities

• Coordinate study start-up activities, including document submission and regulatory compliance
• Maintain regulatory documentation and oversee electronic regulatory binders for multi-site projects
• Create and manage eSource documentation databases throughout the study lifecycle

Required qualifications

• Bachelor's degree
• One year of relevant program experience
• Familiarity with regulatory processes and documentation for clinical trials
• Experience with electronic data management systems
• Knowledge of IRB and safety reporting requirements