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Senior Clinical Research Associate Amsterdam Netherlands,  


Posted on : 10 April 2017

Project Description

  • the senior Clinical Research Associate (CRA) is responsible for ensuring that investigational sites perform clinical studies according to the study science)" rel="nofollow">Protocol and in Compliance with sops, applicable regulations and the principles of Good Clinical Practice
  • he or she acts as the main line of communication between the Project Manager and the Investigator and will perform regular monitoring visits.
  •  moreover, he or she will assist in identifying, selecting and initiating investigational sites.




role and responsibilities
  • identifying and Recruiting investigational sites 
  • performing selection visits 
  • assisting in the preparation of regulatory submission packages and obtaining approval from investigational sites 
  • performing initiation visits 
  • providing input on study related documents 
  • performing monitoring visits to verify that source data/documents and other trial records are accurate, complete, and maintained 
  • verifying patient eligibility and communicate document science)" rel="nofollow">Protocol violations and non-Compliance 
  • verifying whether serious Adverse Events are reported according to safety regulations 
  • checking drug accountability and handling at the investigational sites 
  • preparation and maintenance of all necessary study files and Documentation 
  • helping that Investigators achieve their Patient Recruitment targets 
  • liaising with the Project Manager to ensure he/she is kept informed 
  • preparation of monitoring visit reports 
  • ensuring a timely and accurate resolution of Data Management queries 
  • assisting in the performance of feasibility studies 
  • supporting site staff in preparation for trial site audits and inspections 
  • participation in the Training of new clinical research staff 
  • performing co-monitoring visits 
  • contributing to other areas of company business as required 




qualifications and characteristics of the ideal candidate  
  • degree in Medicine, Health Care, sciences" rel="nofollow">Life sciences or related fields 
  • in-depth knowledge of Good Clinical Practice (gcp) and local regulations and processes 
  • at least 2 years of monitoring/CRA experience 
  • experience with coordinating other CRAs or leading a team 
  • excellent organization and management skills 
  • understanding of the dutch language 
  • fluency in written and spoken English 
  • foreign language skills preferred 
  • in possession of driving license 
  • interest in oncology 
  • good Communication Skills 
  • representative and outgoing 
  • administrative excellence 
  • self motivated and proactive 



offer:
  • our mission is to provide direction to our clients during the entire Drug Development path from drug to data to dossier (the so-called 4d  concept). 
  • becoming our  Employee allows you to actively contribute to bringing innovative Cancer therapies to patients
  • as a fast-growing dynamic company, we offer exciting opportunities to further develop yourself. 
  • we invest in our Employees, want them to be happy and secure in their jobs, and to become autonomous, flexible, oncology experts that deliver high-quality work.

Locations

1098 XH Amsterdam The Netherlands

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