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Senior Clinical Research Associate - Sweden, Denmark, Finland, Norway  

Company managed [?] Still accepting applications
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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