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Administracja biurowa » Pracownik biurowy

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Senior CRA - Italy Nr ref.: /JOBS.pl My client is looking for SR CRAs across Italy to work sponsor dedicated. Their diversity of projects will allow you to gain experience and be familiar with different therapeutic areas and protocols. You may work office based or home based in Italy.They are are hiring experienced CRAs to conduct monitoring visits for assigned protocols and study sites, and ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Responsibilities:The Senior CRA will perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areasAdminister protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issuesEvaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulationsManage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolutionCreate 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 Skills and Experience: Knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesGood therapeutic and protocol knowledge as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPoint Education and Qualifications: Bachelor's degree in a health care or other scientific discipline +1 year of monitoring experienceFluently in English and Italian is a must Availability to travel will be required.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on or upload your CV on our website . A full job description is available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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