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Senior Clinical Research Associate Roosendaal Netherlands,  

Siron (company)


Posted on : 06 July 2017

Project Description

 company structure 
  • our company  is a small organization with short communication lines and room for initiative.
  •  the atmosphere is informal. employees are expected to have a great sense of responsibility and be able to work independently; 
  • Training, and control is possible.   


  • as a senior Clinical Research Associate you independently work on more complex clinical research projects according to our company  and/or sponsor standard operating procedures, ich-gcp, FDA and other applicable guidelines.   
  • you are responsible for conduct of feasibility, pre-study and initiation visits, all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, liaise with vendors and for all aspects of site management as prescribed in the project plans.   
  • in addition to this other duties can be assigned.   
 

qualifications and experience  
  • University degree, preferably in science or Health related discipline;  
  • minimum of 5 years experience in monitoring and conducting global clinical research within gcp/ich and local guidelines, laws and requirements;  
  • extensive knowledge of Clinical Trial monitoring, Ethics committee and competent authority submissions, site contract negotiations and all applicable regulations and guidelines;  
  • excellent written and verbal Communication Skills;  
  • strong organizational, Time Management, and Problem Solving skills and the ability to work independently; 
  • superior interpersonal skills, able to work within a multicultural environment and assertively deal with difficult situations; 
  • proven ability to manage multiple activities, meet timelines and set priorities; 
  • fluent in dutch, English and French, spoken and written; 
  • strong knowledge of computers and standard computer Applications;  
  • Flexibility and ability to travel routinely as required by the study    
 

Locations

4701 LJ Roosendaal Netherlands

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