Clinical Research Regulatory Assistant

Medical University of South Carolina (MUSC); Charleston (SC); On-site; USD 52,272,000 - 83,607,000; Full time

Job summary

The Medical University of South Carolina (MUSC) seeks a Clinical Research Assistant to support the regulatory team. The role involves maintaining regulatory files, building electronic binders, and coordinating site visits and sponsor audits to keep studies in good standing.

Responsibilities include managing CVs and licenses, routing documents for signatures, and assisting with continuing reviews and REDCap data entry. Strong attention to detail is essential.

Qualifications

• High school diploma and three years of relevant program experience.
• Bachelor's degree may substitute for the required program experience.
• Ability to manage regulatory documents accurately.
• Experience with regulatory processes and audits is a plus.

Responsibilities

• 35% - Meticulous management of regulatory documentation for the program's regulatory files; maintain up-to-date CVs, licenses, trainings, conflict of interests, and other documents; ensure accessibility for site monitors.
• 35% - Build electronic regulatory binders; alert staff to new documents; route and track document signatures; prepare files for on-site visits and audits and reconcile action items.
• 15% - Assist with scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews on all open studies.
• 10% - Assist with Source Database building in REDCap.
• 5% - Provide general office support as needed.

Skills

Regulatory documentation

IRB communications

Regulatory compliance

Education

High School Diploma

Bachelor's degree

Tools

REDCap

Job description

The Medical University of South Carolina (MUSC) seeks a Clinical Research Assistant to support the regulatory team. The role involves maintaining regulatory files, building electronic binders, and coordinating site visits and sponsor audits to keep studies in good standing.

Responsibilities include managing CVs and licenses, routing documents for signatures, and assisting with continuing reviews and REDCap data entry. Strong attention to detail is essential.