Study Start-Up - Clinical Research Associate (SSU CRA)
Sponsor dedicated, less travelling
CRA 1- Sr CRA 1 level
Overview
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables in the country. Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key to this role.
Accountabilities
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team to ensure timelines and deliverables are met.
Conducts site selection visits, verifies site eligibility for a specific study.
Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation.
Ensures that milestones (KPIs) and time schedule for study start-up are met as planned.
Facilitates the preparation and collection of site and country level documents.
Collects submission-relate...