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三福生醫股份有限公司

Clinical Research Associate (CRA) I

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Description

BioPhoenix | Clinical Research Associate (CRA I / II / Senior CRA)

BioPhoenix is seeking a motivated CRA to support the planning, execution, and oversight of clinical trials across multiple therapeutic areas. You will collaborate with internal teams, sites, CROs, and vendors to ensure strict adherence to protocols, ICH-GCP, and quality standards.

Core Responsibilities

  • Trial & Site Management: Conduct full-cycle site visits (qualification to close-out), perform source document verification (SDV), review eCRFs, and monitor enrollment and deviations.
  • Relationship & Vendor Oversight: Build strong relationships with investigators and site staff. Oversee CROs, central labs, and vendors, ensuring adherence to timelines and quality expectations.
  • Study Support: Assist Clinical Project Managers with study planning, document development (e.g., Monitoring, Vendor, and Site Management Plans), and risk mitigation.
  • Quality & Compliance: Maintain an inspection-ready Trial Master File (TMF), ensure audit readiness, support CAPA implementation, and strictly adhere to ICH-GCP and local/international regulations.

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