- Early Clinical Development division (ECD) ° CRA (min 2 yrs monitoring experience, phase I - II a plus) - home-based - Rome/Milan preferred but we are open for other locations as well!
Can you bring your drive to our cutting-edge clinical projects?
We need CRA II (ideally from 2 to 4 yrs exp) who are ready to apply their pre-study, initiation, monitoring and closeout visits expertise, and their deep ICH-GCP and SAE management expertise to bring safe, effective and essential medicines to market sooner.
For some roles, experience monitoring international, ph II-III trials in oncology is a must.
Your rewards : ° Up to a EUR 5,000 sign on bonus - limited time only, apply now! ° The opportunity to pursue further training and an interesting career in an inspiring environment that values achievement, supports a balance between your personal and professional life and allows you to make meaningful contributions ° Flexible conditions and an attractive remuneration package Interested candidates have to transmit their personal cv according to the Italian legislative decree n° 196/2003
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements • Thorough knowledge of monitoring procedures • Basic understanding of the clinical trial process •Good in IT •E-CRF experience •Multitasking/ time mgmt •Training skills to train sites •Stress resistant •Confront constructively to get it done as well keep site
Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Good planning, organization and problem solving abilities • Ability to work with minimal supervision • Good communication and interpersonal skills • Good analytical and negotiation skills • Computer competency • Fluent in local office language and in English, both written and verbal • Works efficiently and effectively in a matrix environment
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