Clinical Research Associate
Core
Ensuring delivery and compliance of clinical studies at assigned sites through monitoring, data review, and site management.
Role type
Clinical Research Associate (CRA)
Builds
Clinical studies for Alexion
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Clinical monitoring, site selection and initiation, data review, enrollment management, regulatory document collection, risk-based quality management (RBQM), KPI tracking, report writing
Preferred skills
Study start-up, investigator nomination, feasibility activities
Technologies
CTMS, eTMF
Responsibilities
Perform identification, selection, initiation, monitoring, site data review and closeout activities; drive performance at sites; identify and resolve study-related issues; train and advise Investigators and site staff; develop recruitment plans and manage enrollment; ensure monitoring KPIs are observed; prepare and finalize monitoring visit reports; ensure timely collection/uploading of essential documents into eTMF; support study start-up and regulatory maintenance in some countries; contribute to investigator nomination and feasibility activities