Clinical Research Regulatory Assistant

Medical University of South Carolina; South Carolina; On-site; USD 25,000 - 40,000; Full time

Job summary

The Medical University of South Carolina seeks an Clinical Research Assistant to support the regulatory team by maintaining regulatory documents, building electronic binders, and coordinating site monitoring visits.

You will work under the program’s regulatory team, communicating with investigators, IRB, and sponsors to keep studies in good standing and preparing materials for audits and visits. This role emphasizes meticulous document management and office support.

Qualifications

• High school diploma required; bachelor's degree may substitute.
• At least three years of relevant program experience.

Responsibilities

• Meticulous management of regulatory documentation for the program’s regulatory files; keep CVs, licenses, training records current.
• Build electronic regulatory binders and alert staff to new documents; route, file and track signatures.
• Prepare regulatory files for on-site monitoring visits, sponsor audits and regulatory authority audits; reconcile action items.
• Assist with scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews.
• Support Source Database building in Redcap and provide general office support as needed.

Skills

Regulatory documentation

File management

Communication

REDCap

Education

High school diploma

Bachelor's degree substitution for experience

Tools

REDCap

Job description

The Medical University of South Carolina seeks an Clinical Research Assistant to support the regulatory team by maintaining regulatory documents, building electronic binders, and coordinating site monitoring visits.

You will work under the program’s regulatory team, communicating with investigators, IRB, and sponsors to keep studies in good standing and preparing materials for audits and visits. This role emphasizes meticulous document management and office support.