Sr Clin Res Assoc II
Covance
Leiden, Netherlands
55 minuuten geleden

Job Overview :

Discover new opportunities to grow your career as a Covance's Clinical Research Associate.

Covance is looking to hire SCRA - sponosor dedicated

Responsibilities :

  • all aspects of study site monitoring including routine monitoring and close out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits;
  • liaise with vendors; and other duties, as assigned

  • all aspects of site management as prescribed in the project plans
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
  • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
  • Education / Qualifications :

  • University degree - Life Science
  • Experience :

  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Excellent understanding of Serious Adverse Event (SAE) reporting
  • Ability to resolve project-related problems and prioritize workload for self and team
  • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
  • Ducth and English is must
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