Clinical Assistant (FSP), Shanghai

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