Senior Clinical Trial Assistant - Outsourced to Global Pharma
ProClinical Recruitment
OSLO, Norway
42 dager siden

ProClinical is currently working with a Nordic full-service CRO that is seeking a Senior Clinical Trial Assistant to be based in Oslo on a permanent basis.

Job Responsibilities :

  • Work with the Study Team in initiating, maintaining and closing / final archiving of the SMF, ensuring GCP compliance
  • Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM / Lead CRA or CRA
  • Maintenance of electronic files
  • Set up the Investigator's File in cooperation with CRA
  • Main point of contact regarding SMF
  • Set up and maintain the SMF in cooperation with Lead CRA / PM including SMF checking
  • Coordinate study supplies
  • Drafts and / or assists with the preparation of trial-related documents, tools and templates
  • Actively take part in Study Team meetings and be responsible for the minutes
  • Assist in activities associated with audits and regulatory inspections
  • SMF completion and preparation of shipment to sponsor in cooperation with Lead CRA / CRA
  • Create and keep updated IEC / IRBs Database
  • Assist the PL or Lead CRA managing contracts with sites, including contract status
  • May support the CRAs with some monitoring remote activities : collection of documentation, follow up on data entry, queries resolution
  • Skills and Requirements :

  • Bachelor's Degree preferred
  • 3-5 years of relevant experience, including at least 3 years as CTA
  • Very good written and communication skills
  • Knowledge of GCP / ICH guidelines
  • Very good organizational skills
  • Good software and computer skills
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