Clinical Study Assistant

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Providing clinical trial administration support to LTM/CDC TMs and all CRAs in Turkey

  • Oversight of all trial documentation for assigned clinical trial, covering all involved adjacent affiliates within the CDC
  • CTA documentation to support affiliates in HA and EC submissions - Ensure overview of local requirements
  • TMF handling and archiving
  • Timely uploading of trial documentation in electronic filing system
  • Compliance check of electronic filing system, Ensure timely and adequate archiving at closeout
  • Providing Investigator Trial Master Files (ITMFs) set-up and core input
  • Supporting and tracking trial related payments (e.g. Investigator fees), including invoice processing
  • Organisation of local meetings
  • Supporting local safety reporting to PIs and HAs as relevant
  • Supporting clinical supplies management and tracking all relevant processes
  • Super User as relevant (e.g. electronic filing system)

You are:

• A minimum of 1-year clinical operations experience, preferably within the pharmaceutical or biotechnology industry
• Basic knowledge and understanding of Essential Documents, CFR and/or GCP/ICH 
• Fluently in English
• Proficiency with technological systems (Microsoft Office, Excel, PowerPoint, SharePoint Online, eTMF and CTM.
• Fundamental understanding of filing systems and organizational tools
• BS/BA or equivalent preferred, or relevant and qualifying training/experience