[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
Required skills
Clinical monitoring, Site selection and initiation, Risk-Based Quality Management (RBQM), Recruitment planning, eTMF management, Regulatory submission support, Audit preparation, Data privacy compliance
Preferred skills
Experience in all study phases, Rare disease experience, Change management, Process improvement, Multi-tasking, Technology adoption
Technologies
CTMS, eTMF, Clinical Monitoring Plan (CMP) systems
Responsibilities
Perform selection, initiation, interim monitoring, and closeout visits; Drive site performance and resolve issues; Train and advise investigators on study matters; Develop and manage recruitment plans; Monitor KPIs and quality metrics; Prepare monitoring visit reports; Collect and upload essential documents to eTMF; Support study start-up and regulatory maintenance; Collaborate on investigator nomination and feasibility; Prepare for audits and regulatory inspections.
Seniority
Senior, hands-on IC