Regulatory Trial Coordinator – Pulmonary

musc; Charleston (SC); On-site; USD 45,000 - 77,000; Full time

Job summary

Medical University of South Carolina (MUSC) is seeking a Regulatory Coordinator for the Clinical Trial Research Program, focusing on Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology, and Hepatology. The role collaborates with Clinical Research Coordinators and the Program Manager to meet deadlines and ensure SOP compliance.

Responsibilities include coordinating study regulatory processes, preparing regulatory binders, maintaining electronic files, and handling IRB/CIRB

Qualifications

• Bachelor's degree and one year of relevant program experience are required.
• Experience coordinating and maintaining regulatory documentation and submissions.

Responsibilities

• 25% - Study Start-up and Maintenance: manage start-up activities, submit amendments, and maintain regulatory approvals.
• 20% - Regulatory Documentation: manage CVs, licensure, conflicts of interest, and build electronic regulatory binders.
• 20% - Source Documentation: create and maintain eSource docs and databases for the study lifecycle.
• 15% - Study monitoring and audits: ensure documents are complete and address action items with CIRB involvement.
• 10% - Administrative: provide support to program managers and staff.
• 5% - Safety Reporting: handle IRB/sponsor reportable events per protocol.

Skills

Regulatory docs

IRB processes

Regulatory coordination

Education

Bachelor's degree

Job description

Medical University of South Carolina (MUSC) is seeking a Regulatory Coordinator for the Clinical Trial Research Program, focusing on Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology, and Hepatology. The role collaborates with Clinical Research Coordinators and the Program Manager to meet deadlines and ensure SOP compliance.

Responsibilities include coordinating study regulatory processes, preparing regulatory binders, maintaining electronic files, and handling IRB/CIRB