Clinical Research Associate (CRA)
Core
Support the planning, coordination, and execution of single- and multi-site clinical research studies for medical devices and diagnostics.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trials and research studies
Domain
Medical devices / In-vitro diagnostics / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study operations, site coordination, EDC monitoring, data review, study documentation, site feasibility, regulatory compliance, recruitment support, supply chain management, budget development, audit support
Preferred skills
Medical device study experience, in-vitro diagnostics experience, pharmaceutical clinical research experience, CRA certification (CCRA/CCRC/CCRP), GCP certification, sleep and respiratory medicine experience
Technologies
EDC systems, clinical trial management systems, Microsoft Office (SharePoint, Word, Excel, PowerPoint, Outlook), eTMF
Responsibilities
Support planning, start-up, execution, monitoring, and closeout of clinical studies; Conduct site feasibility assessments and selection; Perform EDC monitoring and centralized data review; Coordinate study operations with sites, vendors, and CROs; Develop study documents including protocols and reports; Track enrollment, retention, and adverse events; Support IRB and regulatory submissions; Manage study supplies and equipment; Support audit and inspection readiness
Seniority
Mid-level, hands-on IC
