Clinical Research Assistant

Stryker

Onsite
Ich/gcp/gdp guidelines adherence
Clinical study document tracking
Etmf and sponsor master binders
The Clinical Research Assistant supports the Stryker NV China Clinical Affairs team in the execution of clinical study management, operational activities as well as medical writing projects

Job Summary

  • The Clinical Research Assistant supports the Stryker NV China Clinical Affairs team in the execution of clinical study management, operational activities as well as medical writing projects.
  • Ensures strict adherence to applicable regulations, ICH/GCP/GDP guidelines, and Stryker NV SOPs while executing administrative aspects of study management from start-up through closeout.
  • Responsibilities include status report generation, payment processing, device maintenance, regulatory document tracking, CRF files, and maintaining study files in an inspection-ready state.

Matching Summary

The Clinical Research Assistant supports the Stryker NV China Clinical Affairs team in the execution of clinical study management, operational activities as well as medical writing projects.

Skills & Requirements

Must-have

  • ICH/GCP/GDP guidelines adherence
  • Clinical study document tracking
  • eTMF and sponsor master binders
  • Investigator Meeting coordination
  • Clinical Trial Management System (CTMS)
  • Trial Master File (TMF) maintenance

Nice-to-have

  • Process improvement initiatives
  • Team efficiency enhancement
  • High attention to detail
  • Fast-paced environment adaptability

Key Requirements

  • Bachelor's degree or equivalent
  • 1+ year relevant experience
  • Fundamental knowledge of GCPs
  • Biotech, Healthcare or Pharma background
  • Team based work experience
  • Working proficiency in English
  • Strong Microsoft Office Suite knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter