CRA II - Denmark

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.

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@covance.com or for a confidential discussion please call Andy Smith on + 44 1635 253 724 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