Clinical Research Associate / Senior CRA
Core
Conduct clinical monitoring for medical device trials in Cardiology to ensure study integrity and protocol adherence at assigned sites.
Role type
Senior Clinical Research Associate (Medical Device)
Builds
Clinical evidence for structural heart disease innovations
Domain
Medical Device / Cardiology
Required skills
Clinical trial site monitoring, Medical device trial experience, Regulatory compliance, Adverse event reporting, Case Report Form (CRF) management, Audit readiness, Protocol deviation management, Site enrollment tracking, Device accountability, Ethics Committee interaction
Preferred skills
Cardiology study experience, MS Office Suite proficiency, Problem-solving, Critical thinking, Relationship management
Technologies
MS Office Suite
Responsibilities
Conduct national and regional monitoring visits at clinical sites, Serve as key contact for assigned sites, Report site enrollment progress and protocol deviations, Process adverse events and device-related complications, Collect and audit Case Report Forms (CRFs), Ensure audit readiness for internal and external audits, Collaborate with internal stakeholders and external authorities.
Seniority
Senior, hands-on IC
