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Senior Clinical Research Associate Sweden, København Denmark, Vantaa Finland, Norway,  

IRW (company)


Posted on : 10 July 2017

Project Description

desirable qualifications and background
  • academic degree in Natural science such as Life Sciences, Pharmacy or Nursing
  • at least 4 years of Clinical research experience in the Pharmaceutical/CRO industry (including site initiation, monitoring and site closure).  
  • computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint 
  •  good ability to express yourself both verbally and in writing 
  • good knowledge of spoken and written English and local language 
  • good organizational skills 
  •  a service-minded approach 
  • ability to prioritize and handle several tasks simultaneously 
  • valid driving license 
  •  position requires occasional travel both national and internationally  



principal duties
  • prepare and complete Applications to the regulatory authorities and ethic committees 
  • responsible for completion of study Documentation such as crfs, patient diaries, qol forms etc. 
  • preparing monitoring manuals, source data Verification plans, clinical management plan etc. 
  • responsible for the sites and on-site management during the study process 
  • drug accountability 
  • participate in audits and inspections, co-monitoring and accompanied site visits. 
  • select and negotiate contracts with 3rd party providers. 
  • assist in data Validation and clean file procedures 
  • prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits 
  • selecting and negotiating contracts with local/central laboratories, pharmacies etc. 
  • Planning and participating at investigators meeting 
  • responsible for final archiving of study documents in-house and on-site 

Locations

182 17 Danderyd Sweden1310 København K DenmarkRajatorpantie 41 01640 Vantaa FinlandNO 1366 Lysaker Norway

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