CRA I or II - Client based
Covance Inc
Rueil-Malmaison, France
il y a 2j

Job Overview :

Covance is looking for a CRA II to be client dedicated with a top 10 pharmaceutical company in France.

This is a permanent position office based in Paris. Therapeutic areas include Oncology, Diabetes, cardio and rare diseases.

Job Summary

  • Performs / participates in study site selection visits in the investigational sites
  • Performs Primary CRA function for eCRF studies during the set-up phase
  • Prepares / collects all study site essential documents needed prior to study initiation in collaboration with the Clinical Project Assistant (CPA) and Start-Up / Regulatory Team
  • Facilitates negotiation of site Clinical Trial Agreements (CTA) prepared by the Regional / Local Clinical Project leader (RCPL) or Start-Up / Regulatory Team
  • Ensures that sites apply for and receive hospital / practice / institution approval (e.g. R&D).
  • Organises / participates in study initiation meetings in which are provided scientific and technical knowledge concerning the study procedures and its organisation
  • Works with RCPL, Lead CRA and CPA to prepare, organise and participate in investigator meetings.
  • Assists the RCPL / CPA in maintaining and ensuring the completeness of the local study files, checking the country-level (when Lead CRA for studies with regional CPL) and centre-specific files at regular intervals and reconciling with the investigator study files
  • Education / Qualifications :

    Appropriate education (life science degree / nursing qualification)

    Experience :

    CRA experience with at least 1 years’ monitoring experience

    Knowledge of and experience with GCP and other regulations; ability to learn and apply SOPs

    Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting

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