06 set - Italia
BeOne Medicines
Be One continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. CRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region. May be assigned to CRA activities or start-up activities, depending on experience and project needs. CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained. CRA identifies gaps and areas for improvement and propose CAPA.
CRA supports start-up and provides local expertise. expertise. Essential Functions Of The Job Complete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties. Gain experience in Be One and study procedures by working with experienced clinical staff. Perform site selection and evaluation, supporting initial list of sites and recruitment targets. Provide protocol and related study training to assigned sites. Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs. Conduct co-monitoring visits, if required. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation, in accordance with ICH-GCP, Be One standards and SOPs. Manage sites and site per
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UNA Forza Vendite - Business line Openjobmetis