[Alexion] Clinical Research Associate (Fixed Term)

Contract Term: 1 year 6 months

This is what you will do:

• The  Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at their assigned sites and is an active participant in the local study team(s). The  CRA works in close collaboration with local team members (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure delivery and compliance.
• The  CRA is responsible for the identification, selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations,  and that the sites deliver according to their respective commitment in the individual studies.
• A CRA with demonstrated skillset and experience may take on additional study level responsibilities and tasks as needed (e.g.  Lead CRA, etc).

You will be responsible for:

• Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
• Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
• Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.
• Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and implement mitigation plans.
• Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV m...

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