UNIV - Clinical Research Assistant - Department of Medicine: Division of Pulmonary

Medical University of South Carolina • Charleston, SC

5d • $37,200 - $59,500 • Onsite

About The Position

This Clinical Research Assistant will work with the program’s regulatory team to provide program support for regulatory processes. They will communicate as needed with the investigator, IRB, and study sponsors to keep program studies in good standing.

Requirements

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

Responsibilities

• Responsible for meticulous and careful management of regulatory documentation of the Program’s regulatory files; maintains up-to-date files of CVs, medical licensure, note-to-files, conflict of interests, training documentation, laboratory certifications and other documents as needed. Ensures regulatory documents are updated in a timely manner and available for the site monitor at all times.
• Build electronic regulatory binders. Alert staff of new documents that are available and ensure documents are filed. Route and track completion of documents requiring signature. Will be responsible for preparing regulatory files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits.
• Assist with the following as needed: scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews on all open studies.
• Perform other duties as required. Assist with Source Database building in Redcap.
• Provide general office support as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED