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Clinical Trial Documentation Associate Sofia Bulgaria,  

KCR (company)

Posted on : 13 June 2017

Project Description

The duties associated with the role include:       
  • Assisting with the development and oversight of Trial Master File document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established procedures and policies. 
  • Preparing and is responsible for maintaining assigned Trial Master setup based on provided Document Management Plan. 
  • Preparing files from TMF according to communicated deadlines. 
  • Monitoring the TMF routinely for document availability using defined tools and/or routine procedures according to agreed upon metrics and performs escalation per process definition. 
  • Performing quality control of assigned TMF parts per documented schedule. 
  • Participating in preparation of the completed studies for archiving. 
  • Reporting about unresolved problems that appear during the cooperation process.  

  • Minimum of six (6) months of clinical research experience 
  • Knowledge of GCP including a basic understanding of regulatory requirements 
  • University / college degree 
  • Administrative skills 
  • Fluency in English 
  • Eagerness to learn medical / clinical research vocabulary and procedures 
  • Excellent organization skills, patience, attention to detail 
  • Very good communication skills 
  • Teamwork ability 
  • Computer competency  


Warsaw PolandSofia Bulgaria

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