Clinical Research Associate II
Core
Manage clinical sites and monitoring activities for medical device studies to ensure compliance, data accuracy, and successful study execution.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical studies for medical device products
Domain
Medical Technology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical site monitoring, GCP/ICH/ISO14155 compliance, TMF management, CTMS/eTMF proficiency, regulatory knowledge, data query resolution, audit support, stakeholder communication, travel management
Preferred skills
Peripheral vascular disease study experience, oncology study experience, end-stage kidney disease study experience, Veeva Vault CTMS/CDMS/eTMF experience, ACRP/SOCRA certification
Technologies
Microsoft Suite, eTMF, CTMS, CDMS
Responsibilities
Conduct on-site and remote clinical site monitoring for qualification, activation, and follow-up; ensure study compliance with GCP and regulations; manage Trial Master File (TMF) quality and audit readiness; develop clinical site activation checklists and monitoring reports; support Clinical Project Management with administrative tasks; mentor junior monitoring personnel; facilitate communication between sites and cross-functional teams.
Seniority
Mid-Senior, hands-on IC