[Alexion] Sr. Clinical Research Associate
Core
Senior Clinical Research Associate responsible for site selection, initiation, monitoring, and closure of clinical studies to ensure compliance and timely delivery.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trials for rare medical conditions
Domain
Biopharmaceuticals / Clinical Research
Deliverable
physical/clinical work
Required skills
Clinical monitoring, Site selection and initiation, Regulatory compliance (ICH-GCP), Recruitment management, Data quality management, eTMF management, Study start-up support, Risk-Based Quality Management (RBQM)
Preferred skills
Experience in all study phases, Experience in rare medical conditions, Change management, Process improvement, Multi-tasking, Technology adoption
Technologies
CTMS, eTMF
Responsibilities
Perform selection, initiation, interim monitoring, and closeout visits (remote and on-site); Drive site performance by identifying and resolving issues; Train and advise investigators on study matters and RBQM; Develop recruitment plans and manage enrollment; Monitor KPIs (action-item ageing, query ageing, etc.); Prepare monitoring visit reports and feedback; Collect and upload essential documents to eTMF; Support study start-up and regulatory maintenance; Collaborate on audit and inspection preparations.
Seniority
Senior, hands-on IC