Clinical Research Associate II
Core
Conduct single or multi-center medical device clinical studies, managing site visits, data review, and regulatory compliance from study startup to final report.
Role type
Mid-level Clinical Research Associate (Medical Devices)
Builds
Clinical study deliverables and regulatory submissions for medical devices and diagnostics
Domain
Healthcare / Medical Devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site monitoring, clinical study execution, regulatory compliance (GCP/ICH), data review, study startup management, CRO management, travel
Preferred skills
Medical device study experience, in-vitro diagnostics experience, clinical trial management systems, project management, problem solving
Technologies
Microsoft Suite
Responsibilities
Conduct site visits (SQV, SIV, IMV, COV) and generate monitoring reports; Manage clinical monitoring activities ensuring protocol and regulatory compliance; Assist in study startup, CRF design, and investigator training; Review clinical data listings for accuracy; Maintain Trial Master File for inspection readiness; Participate in cross-functional planning and regulatory submissions.
Seniority
Mid-level, hands-on IC