Regulatory Coordinator, Pulmonary Clinical Trials

Medical University Hospital Authority (MUHA); United States; On-site; USD 46,000 - 78,000; Full time

Job summary

Medical University of South Carolina (MUSC) seeks a Regulatory Coordinator for the Clinical Trial Research Program spanning Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology and Hepatology. You will coordinate regulatory processes with coordinators and the program manager to ensure deadlines are met while following SOPs.

Responsibilities include maintaining regulatory documents, building electronic binders, and ensuring regulatory compliance across multi-site projects.

Qualifications

• Bachelor's degree required; 1 year of relevant program experience preferred.
• Experience coordinating regulatory aspects of clinical trials is a plus.
• Strong knowledge of IRB processes and SOP adherence.

Responsibilities

• Coordinate and maintain study regulatory documents and binders.
• Submit amendments and continuing reviews to IRB; ensure timely approvals.
• Maintain regulatory files for multi-site studies; develop regulatory templates.

Skills

Regulatory coordination

IRB submissions

SOP adherence

Study start-up

Education

Bachelor's degree

Tools

ClinicalTrials.gov

eSource databases

Job description

Medical University of South Carolina (MUSC) seeks a Regulatory Coordinator for the Clinical Trial Research Program spanning Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology and Hepatology. You will coordinate regulatory processes with coordinators and the program manager to ensure deadlines are met while following SOPs.

Responsibilities include maintaining regulatory documents, building electronic binders, and ensuring regulatory compliance across multi-site projects.