Clinical Trials Regulatory Assistant

musc; Town of Charleston (NY); On-site; USD 38,000 - 61,000; Full time

Job summary

Medical University of South Carolina (MUSC) is seeking a Clinical Research Assistant to support regulatory processes within the program's regulatory team. You will communicate with investigators, IRB, and study sponsors to keep studies in good standing and ensure timely regulatory filings.

Key duties include meticulous management of regulatory documents, building electronic regulatory binders, routing signatures, and supporting monitoring visits and sponsor audits.

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

• 35% - meticulous management of regulatory documentation and up-to-date files.
• 35% - build electronic regulatory binders and route/signature tracking.
• 15% - assist with scheduling/remediation of monitoring visits and annual reviews.
• 10% - assist with Source Database building in RedCap.
• 5% - provide general office support.

Skills

Regulatory documentation

REDCap

Study coordination

Monitoring support

Attention to detail

Education

High school diploma

Bachelor's degree may substitute experience

Tools

RedCap

Electronic filing systems

Job description

Medical University of South Carolina (MUSC) is seeking a Clinical Research Assistant to support regulatory processes within the program's regulatory team. You will communicate with investigators, IRB, and study sponsors to keep studies in good standing and ensure timely regulatory filings.

Key duties include meticulous management of regulatory documents, building electronic regulatory binders, routing signatures, and supporting monitoring visits and sponsor audits.