Pulmonary Clinical Research Regulatory Coordinator

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

Job summary

The Medical University of South Carolina invites applications for a Regulatory Coordinator in the Clinical Trial Research Program, serving Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology and Hepatology. You will work with Clinical Research Coordinators and the Program Manager to meet all regulatory deadlines and ensure SOPs are followed.

Key duties include study start-up oversight, maintaining regulatory documentation, building electronic binders, coordinating IRB

Qualifications

• Bachelor's degree and one year of relevant program experience.
• Experience coordinating regulatory documents and IRB submissions.
• Knowledge of ClinicalTrials.gov and adverse event reporting.
• Ability to prepare regulatory binders and SOP adherence.

Responsibilities

• 25% - Study Start-up and Maintenance: receive sponsor packet, initiate start-up activities, activate amendments, and manage IRB communications.
• 20% - Regulatory Documentation: maintain regulatory documents, build electronic binders, oversee multi-site regulatory files and templates.
• 20% - Source Documentation: create and maintain eSource databases, coding, reporting, and alerts across the study life cycle.
• 15% - Study monitoring and audit visits: ensure complete regulatory binders, coordinate with monitors, address corrective actions, stay updated on CIRB policies.
• 10% - Administrative: provide program support, schedule meetings, support events and site tours.
• 5% - Safety Reporting: handle IRB/sponsor reportable events per protocol and guidelines.
• 5% - Other: assist with additional study tasks as needed.

Skills

Regulatory coordination

IRB familiarity

Study start-up

Documentation management

Clinical research

Communication

Administrative support

Education

Bachelor's degree

Tools

ClinicalTrials.gov

Job description

The Medical University of South Carolina invites applications for a Regulatory Coordinator in the Clinical Trial Research Program, serving Pulmonary, Critical Care, Gastroenterology, Endocrinology, Nephrology and Hepatology. You will work with Clinical Research Coordinators and the Program Manager to meet all regulatory deadlines and ensure SOPs are followed.

Key duties include study start-up oversight, maintaining regulatory documentation, building electronic binders, coordinating IRB