Contractor CRA_Germany

Responsibilities

(a) Site management

•      Study site selection, initiation ( SIV) and clinical monitoring.

•      Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•      Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•     Ensure Principal Investigator/study staff complies with safety reporting ...