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CRA II - Denmark - GCD

Laboratory Corporation of America Holdings (Covance)

Copenhagen, Denmark

<h2>Job Overview:</h2><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">Labcorp Drug Development</span> is looking for a CRA II to be client dedicated with a top 10 <span style="font-family: Arial; font-size: small;">pharmaceutical company in Denmark. To apply you must be looking for a full time position and be based relatively close to Copenhagen.</span></span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">We can offer a permanemt contract and candidates can be 100% home based.<span style="font-family: Arial; font-size: small;"> Therapeutic areas include Oncology, Diabetes, cardio and rare diseases.  Monitoring frequency will be approximately 6 visits per month.</span></span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Job Summary </span></span></p><ul><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Performs/participates in study site selection visits in the investigational sites </span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Performs Primary CRA function for eCRF studies during the set-up phase</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">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</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Facilitates negotiation of site Clinical Trial Agreements (CTA) prepared by the Regional/Local Clinical Project leader (RCPL) or Start-Up/Regulatory Team</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Ensures that sites apply for and receive hospital/practice/institution approval (e.g. R&D).</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Organises/participates in study initiation meetings in which are provided scientific and technical knowledge concerning the study procedures and its organisation</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Works with RCPL, Lead CRA and CPA to prepare, organise and participate in investigator meetings.</span></li><li><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">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</span></li></ul><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">To apply for this position please email your CV to <span style="text-decoration: underline;">andy.smith<a href="mailto:nicky.cooke@chiltern.com" target="_blank" rel="noopener"><span style="color: black; text-decoration: underline;">@covance.com</span></a></span> or for a confidential discussion please call Andy Smith on + 44 (0)7775 848 250</span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">REMOTE</span></span></p><h2>Education/Qualifications:</h2><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Appropriate education (life science degree / nursing qualification)</span></span></p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;"><br /> <br /></span></p><h2>Experience:</h2><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Candidates must be an experienced CRA with at least 1 years’ monitoring experience</span></p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs</span></p><p style="margin: 0cm 0cm 0pt;"><span style="color: black; font-family: 'Arial','sans-serif'; font-size: 10pt;">Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting</span></p>

Job posted: 2022-01-27

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