Clinical Research Associate 3
Core
Execute pre-market and post-market clinical studies for medical devices, ensuring regulatory compliance and data accuracy across the study lifecycle.
Role type
Senior Clinical Research Associate (Medical Devices)
Builds
Clinical study reports, regulatory submissions, and clinical publications for medical device trials.
Domain
Medical Devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device clinical trial management, Good Clinical Practice (ISO 14155, ICH/GCP), 21 CFR Part 812/50/54/11, protocol and ICF development, site initiation and monitoring, source data verification, EDC systems, clinical literature review, contract negotiation, study financial tracking
Preferred skills
Nursing degree or MD/PhD, hospital environment experience, statistical methods knowledge, clinical trial management systems (CTMS), surgeon/site selection expertise
Technologies
Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Microsoft Office Suite, PDF applications
Responsibilities
Manage site start-up, activation, and close-out processes; conduct on-site and remote monitoring visits; verify source data in EDC systems; organize IRB/EC submissions; track study progress and site payments; assist in study design and site selection; prepare for site audits and inspections.
Seniority
Senior, hands-on IC