Study Start-Up CRA

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs. Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).

Accountabilities

• Supports country SSU strategy in close collaboration with the Study Start-Up Team Lead, the Study Start-Up Manager, and the Feasibility Manager as well as the Site Partnership Manager

• Collaborates with the Study Start-Up Manager, the Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments

• Accountable for timely start-up activities from country allocation until site...