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CRA II - Denmark

JOB DESCRIPTION

Job Overview:

Covance is looking for a CRA II to be client dedicated with a top 10 pharmaceutical company in Denmark. To apply you must be looking for a full time position and be based relatively close to Copenhagen.

We can offer a permanemt contract and candidates can be 100% home based. Therapeutic areas include Oncology, Diabetes, cardio and rare diseases. Monitoring frequency will be approximately 6 visits per month.

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
  • To apply for this position please email your CV to andy.smith or for a confidential discussion please call Andy Smith on + 44 (0)7775 848 250

    REMOTE

    Education/Qualifications:

    Appropriate education (life science degree / nursing qualification)

    Experience:

    Candidates must be an experienced CRA with at least 1 years’ monitoring experience

    Knowledge of and experience with GCP and other regulations in force; 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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