[Alexion] Clinical Research Associate
Core
Monitor clinical studies at assigned sites to ensure delivery, compliance, and data quality while managing site recruitment and documentation.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trials for rare medical conditions
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Clinical monitoring, site selection and initiation, data review, recruitment management, regulatory compliance (ICH-GCP), eTMF management, audit preparation, risk-based quality management (RBQM)
Preferred skills
Experience in all study phases, rare medical conditions, change management, process improvement
Technologies
CTMS, eTMF
Responsibilities
Perform identification, selection, initiation, monitoring, site data review, and closeout activities; drive site performance and resolve study issues; train and advise investigators on study matters and RBQM; develop recruitment plans and manage enrollment; 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
Entry-level to Mid-level, hands-on IC