Clinical Records Associate

We are seeking a Clinical Records Associate for our TMF Operations Department. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations, and 4DMT’s Standard Operating Procedures (SOPs) as appropriate.

Requirements

• A./B.S. degree (preferably in a scientific or healthcare-related field) preferred
• High school diploma required
• 2+ years relevant experience including extensive experience with Veeva Vault TMF or a H.S. diploma with 6+ years relevant experience
• 2+ years of TMF QC Review and knowledge of clinical documentation content required