Филощинская Яна Владимировна

Занятость:

Полная

Ключевая информация:

• Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs).
  
• Updating and maintaining clinical systems (track site compliance and performance within project timelines) - Site Management System, e-TMF 2.0/3.0, Project & Site Documents management systems, Corporate Learning System.
  
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  
• Preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  
• Maintain Trial Master File and back-up files.
  
• Maintain meeting and teleconference minutes.
  
• Central contact for the clinical team for designated project communications, correspondence and associated documentation.
  

In addition:

• Investigators communication and collaboration.
  
• Assist СRA with filing and scheduling as necessary.
  
• Periodic review of study files for accuracy and completeness.
  
• Help to ensure compliance with project specifications and GCPs with regards to documentation.
  
• Other administrative tasks as requested by CRAs or PM.
  

Дополнительно:

Владение языками:

• Английский - продвинутый (могу проходить собеседование на этом языке);
  
• Немецкий - выше среднего.