Clinical Research Associate I
Core
Ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials.
Role type
Junior Clinical Research Associate (IC)
Builds
Clinical trial data and regulatory compliance for medical devices and diagnostics
Domain
Healthcare / Clinical Research / Medical Devices
Required skills
Clinical monitoring, Site management, Regulatory compliance (CFR, ICH-GCP), Data review, TMF management, Travel
Preferred skills
Medical device study experience, In-vitro diagnostics experience, Pharmaceutical background, Microsoft Suite proficiency
Technologies
Microsoft Suite, eTMF
Responsibilities
Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, track resolution of action items, assist with study startup, ship study devices and supplies, perform device accountability, maintain and audit Trial Master File (TMF), review clinical data listings for completeness and accuracy, communicate study status to management, participate in interim and final reviews of study data.
Seniority
Junior, entry-level IC