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.
- 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
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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