Pulmonary Clinical Trials Regulatory Coordinator

Medical University of South Carolina; Charleston (SC); On-site; USD 45,000 - 77,000; Full time

Job summary

The Medical University of South Carolina is hiring a Regulatory Coordinator to support the Clinical Trial Research Program across multiple specialties. The role ensures timely regulatory start-up and ongoing maintenance in compliance with SOPs and IRB requirements.

You will collaborate with Clinical Research Coordinators and the Clinical Research Program Manager to manage regulatory documents, maintain eSource records, and oversee multi-site regulatory activities while supporting program

Qualifications

• A bachelor’s degree and one year of relevant program experience.

Responsibilities

• 25% - Study Start-up and Maintenance: initiate and monitor start-up activities; submit amendments and IRB approvals; maintain study registration (e.g., ClinicalTrials.gov).
• 20% - Regulatory Documentation: maintain CVs, licensures, notes-to-files, COI, lab certs; build electronic regulatory binders; oversee multi-site regulatory files.
• 20% - Source Documentation: create and maintain eSource database; manage life-cycle documentation, reports, and alerts.
• 15% - Study monitoring and audit visits: ensure documents are complete; coordinate with monitors; maintain CIRB policies.
• 10% - Administrative: support Program Manager and Finance/Operations staff; schedule meetings and events.
• 5% - Safety Reporting: handle IRB/sponsor reportable events per protocol.
• 5% - Other: assist with additional study tasks as needed.

Education

Bachelor's degree

Job description

The Medical University of South Carolina is hiring a Regulatory Coordinator to support the Clinical Trial Research Program across multiple specialties. The role ensures timely regulatory start-up and ongoing maintenance in compliance with SOPs and IRB requirements.

You will collaborate with Clinical Research Coordinators and the Clinical Research Program Manager to manage regulatory documents, maintain eSource records, and oversee multi-site regulatory activities while supporting program