Clinical Research Associate I (Start Up Focus)
Core
Supports clinical trial start-up activities for medical device studies, including investigator checks, regulatory document collection, site qualification visits, and study file preparation.
Role type
Clinical Research Associate I (Start Up Focus)
Builds
Clinical trial infrastructure and site readiness for medical device ADC trials
Domain
Medical Devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Investigator debarment checks, regulatory document collection, site qualification visits, study file preparation, trial master file maintenance, audit support, regulatory submissions, travel management
Preferred skills
Medical device study experience, pharmaceutical background, GCP knowledge, Clinical and Regulatory Affairs knowledge, Microsoft Suite proficiency
Technologies
Veeva Vault, Microsoft Suite
Responsibilities
Conduct investigator debarment checks, collect regulatory documents, prepare study files, conduct Site Qualification Visits (SQV), assist with site selection, maintain and audit Trial Master File, support regulatory submissions, communicate trial status to management
Seniority
Junior, hands-on IC
