Clinical Research Associate II
Core
Provide independent site management and monitoring support for clinical studies to ensure quality, compliance, and successful study completion.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical studies for medical technology products
Domain
Medical Device Clinical Research
Required skills
Clinical study regulations (GCP/ICH/ISO14155), Site qualification and activation, Data review and query resolution, TMF management, CTMS/eTMF proficiency, Regulatory document preparation, Audit support, Cross-functional collaboration, Issue escalation and mitigation
Preferred skills
Peripheral vascular disease, end-stage kidney disease, or oncology study experience, Medical device study experience, Veeva Vault CTMS/CDMS/eTMF experience, ACRP/SOCRA certification
Technologies
Microsoft Suite, eTMF, CTMS, CDMS, Veeva Vault
Responsibilities
Conduct on-site or remote clinical site monitoring activities; Ensure quality and compliance for assigned clinical studies; Develop and maintain study-specific tracking reports; Perform study and site-level audits of the Trial Master File; Assist with management of the Clinical Trial Management System; Develop essential clinical study documents; Support internal or external audits/inspections; Mentor Site Management & Monitoring personnel
Seniority
Mid-Senior level, hands-on IC