Clinical Research Associate II
Core
Execute and manage medical device and in-vitro diagnostics clinical studies from concept to report, ensuring compliance with GCPs and regulatory requirements.
Role type
Senior Clinical Research Associate (Medical Devices/Diagnostics)
Builds
Clinical study reports, regulatory submissions, and inspection-ready Trial Master Files
Domain
Healthcare / Medical Devices / In-vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site monitoring, clinical study planning, regulatory compliance (GCP/ICH), data review, CRO management, investigator training, document preparation, audit response
Preferred skills
Medical device study experience, in-vitro diagnostics experience, clinical trial management systems, data analysis, project management
Technologies
Clinical trial management systems, data management systems, Microsoft Suite
Responsibilities
Conduct single or multi-center medical device clinical studies; Perform study site visits (SQV, SIV, IMV, COV) and generate monitoring reports; Manage clinical monitoring activities and site compliance; Assist in study startup, CRF design, and UAT; Select and manage CROs and investigator sites; Maintain and audit Trial Master File; Review clinical data listings for accuracy; Participate in interim and final data reviews for regulatory submissions.
Seniority
Mid-Senior, hands-on IC