info@irwcro.com | +46 8 791 66 40

Desirable qualifications and background

  • Academic degree in natural science such as life sciences
  • Experience from pharmaceutical, biotechnology or medical device industries
  • Experience from Clinical Research Organizations (CRO)
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously
  • Valid driving license

 

Principal duties

  • Prepare and complete applications to the regulatory authorities and ethic committees
  • Prepare and conduct pre-study activities, site selection and initiation visits, routine monitoring and close out visits
  • Negotiate contracts with sites, local/central laboratories, pharmacies etc.
  • Manage assigned sites throughout the study to ensure site compliance, adequate enrolment, and understanding of study requirements
  • Participate in Audits and Inspections
  • Assist in data validation and clean file procedures
  • Planning and participating at Investigators meeting
  • Responsible for final archiving of study documents in-house and on-site