Clinical Research Associate
Core
Ensures compliance of clinical study conduct with ICH/GCP and country regulations, manages assigned sites, and develops new clinical research territories.
Role type
Senior Clinical Research Associate (Site Management)
Builds
Clinical trials for bio/pharma companies
Domain
Healthcare / Clinical Research
Required skills
Site management, Clinical study monitoring, Adverse event reporting, Protocol adherence, Regulatory documentation management, Data analysis, Root cause analysis, IT proficiency (MS Office, clinical apps)
Preferred skills
Experience in bio/pharma/CRO, Knowledge of global/regional guidelines, Multitasking, Conflict management
Technologies
CTMS, eTMF, Adverse Event Reporting Systems, Clinical IT applications
Responsibilities
Conduct remote and on-site monitoring visits (initiation, monitoring, close-out), manage site performance and patient recruitment, collect and review regulatory documentation, communicate with investigators on protocol conduct and deviations, identify and resolve compliance problems, support audit/inspection activities, contribute to site selection and validation.
Seniority
Mid-Senior, hands-on IC
