Senior Clinical Research Associate
Core
Ensuring proper delivery and compliance of clinical studies at allocated sites through selection, initiation, monitoring, and closure.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical studies for Alexion
Domain
Biopharmaceuticals / Clinical Trials
Required skills
Clinical monitoring, site selection and initiation, recruitment management, regulatory compliance (ICH-GCP), data management, audit preparation, risk-based quality management
Preferred skills
Rare medical conditions experience, change management, process improvement, stakeholder communication
Technologies
CTMS, eTMF
Responsibilities
Perform selection, initiation, interim monitoring, and closeout visits (remote and onsite); drive site performance and resolve study issues; train and advise investigators on study matters; develop and manage recruitment plans; ensure monitoring KPIs are met; prepare monitoring visit reports; collect and upload essential documents to eTMF; support study start-up and regulatory maintenance; prepare for audits and regulatory inspections.
Seniority
Senior, hands-on IC