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Clinical Assistant (FSP), Shanghai

SHANGHAI, Shanghai, China 职位编号 R0000031878 类别 Clinical Trials
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Job Description

1.Support trial during Conduct

Site communications

  • Maintain site contact and relevant vendor and regulatory document tracker (tracking of medical licenses and follow-up/annual collection reminders)
  • Printing/mailing documents and equipment to sites (if CRA is not responsible for it)

Vendor communication

  • Support CTM to inform TDS about trial events to trigger document collections for critical documents (eg. Investigator Brochures, signature pages)
  • Co-ordinating translations of documents after review/translation (approvals, applications, advertising, patient materials, ICFs etc.) and submit for TMF filing
  • Support CTM to inform TDS about trial events to trigger document collection
  • Support production and create local signature pages for local/global amendments
  • Resolving COPI reports ,monthly QC document findings
  • Responsible for site address /personnel change, notifications and updates to related forms, supplies and vendor’s spreadsheets etc.
  • Ordering trial supplies and sending to sites (if CRO cannot support)
  • Maintain Paper Trial Master File if applicable

Requirement:

1. At least 1 year CTA related working experiences;

2. Good communication and English skill

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