Clinical Research Regulatory Coordinator

Medical University of South Carolina

Charleston, Northern (SC, KY)

On-site

USD 38,000 - 61,000

Full time

3 days ago

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Job summary

Medical University of South Carolina seeks a Clinical Research Assistant to support the regulatory team in maintaining compliance for program studies. You will manage regulatory files, keep documents updated and ready for site monitors, and help prepare audits.

The role includes building electronic binders, routing documents for signatures, and assisting with scheduling monitoring visits and annual reviews. Office support and data entry in REDCap may be required.

Qualifications

A high school diploma and three years of relevant program experience.
A bachelor's degree may be substituted for the required program experience.

Responsibilities

Meticulous management of regulatory documentation for the Program’s regulatory files; maintain up-to-date CVs, licensure, notes, COI, training, lab certifications, and other documents.
Build electronic regulatory binders; alert staff to new documents; route and track signature-required items; prepare files for on-site monitoring, sponsor audits, and regulatory authority audits; reconcile action items after visits.
Assist with scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews on open studies.
Assist with Source Database building in REDCap.
Provide general office support as needed.