Pulmonary Clinical Trials Regulatory Coordinator

MUSC Health; Charleston (SC); Vor Ort; USD 45.300 - 77.000; Vollzeit

Zusammenfassung

Medical University of South Carolina (MUSC) in Charleston is seeking a Regulatory Coordinator for the Clinical Trial Research Program, supporting multiple specialties. You will coordinate start-up, IRB submissions, and regulatory documentation with the team to ensure timely study approvals and compliance.

You will maintain electronic regulatory binders, support multi-site projects led by MUSC, and assist with audits and safety reporting while collaborating with study teams and regulatory

Qualifikationen

• Bachelor's degree in a relevant field is required.
• Experience with IRB processes and regulatory documentation is preferred.
• Ability to manage regulatory materials and ensure compliance across trials.

Aufgaben

• Coordinate and perform study-specific regulatory activities and ensure SOPs are followed.
• Maintain regulatory documents (CVs, licensure, COI, certifications) and build electronic binders.
• Create and maintain eSource documentation databases for studies from start-up to closure.
• Support study monitoring and audits, ensuring timely action item resolution.
• Provide administrative support to the Regulatory Manager and program team.
• Assist with safety reporting and CIRB-related processes.

Ausbildung

Bachelor's degree in a relevant field

Regulatory coordination

IRB submissions

Regulatory documentation

Source documentation

Study start-up

Jobbeschreibung

Medical University of South Carolina (MUSC) in Charleston is seeking a Regulatory Coordinator for the Clinical Trial Research Program, supporting multiple specialties. You will coordinate start-up, IRB submissions, and regulatory documentation with the team to ensure timely study approvals and compliance.

You will maintain electronic regulatory binders, support multi-site projects led by MUSC, and assist with audits and safety reporting while collaborating with study teams and regulatory