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Project Assistant - United States, Germany, India  



Posted on : 22 April 2017

Project Description

Roles and Responsibilities
  • General administrative work 
  •  Compilation of documents for submissions to ethics committees and regulatory authorities 
  •  Compilation of documents to be appended to clinical study protocols and clinical study reports 
  • Compilation of investigators’ files according to given specifications 
  • Filing and tracking of documents in the different files (trial master file and project file) 
  • Assistance in scheduling of site visits 
  • Storage, dispatch and in-house accountability of investigational medicinal products and other study material 
  •  Organization of investigators’ meetings 
  • Archiving and handing over Trial Master File to the sponsor 
  • First data entry in SAS 
  • Recruiting of new sites, telephone contacts to collect documents 
  • Investigator payments 

  • Successfully completed Project Assistant training 
  •  Knowledge of GCP principles 
  •  Understanding of medical matters 
  •  Good knowledge of English 
  •  Good knowledge of Office software 
  •  Knowledge of general Office procedures 
  •  Adequate IT experience for electronic filing