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.
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)
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