Clinical Trial Monitor

Purpose/Scope:

The Clinical Trial Monitor will work under the Director of Industry Collaboration and Trial Management to oversee trial activity at sites participating in Alliance clinical trials. This position is responsible for completing clinical monitoring activities at participating sites for assigned trials. This includes Source Data Verification (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) in line with NCTN mechanisms, confirm proper utilization and documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.

Role and Responsibilities

• Conduct remote/on-site monitoring visits to ensure compliance with study protocols, clinical monitoring plan, Good Clinical Practice (GCP), institutional policy, and other applicable regulations.
• Draft...