诺和诺德(中国)制药有限公司<br>高级临床研究协调员(Senior CRA)<br>
Area of responsibilities:<br>Main Tasks:<br>Duties and responsibilities which are subject to periodic updating include:<br>Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study.<br>Assisting with preparation of protocols and other necessary documents required for trial approval by HA.<br>Preparing protocols and other necessary documents required for trial approval by EC and getting EC approval on time.<br>Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.<br>Make monitoring plan, co-monitoring plan, budget and tracking plan and followed it during trial process.<br>Tracking progress, status and performance regularly, find current problems/issues and make appropriate action plans.<br>Coordinating and giving input to all activities including query resolution, site closure and collection of documentation required for clinical trial reports after trail end.<br>Ensuring but not limited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.<br>Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP<br>Maintaining, updating and archiving all clinical trial files on time.<br>Maintaining up to date knowledge of diabetes treatment, company products, and clinical trial conduction.<br>Being LTM for CDP trial when needed, keep close contact with IO CDC or HQ project team.<br>Being project leader when needed, coordinate and lead team members have regular project review meeting, ensure accuracy of meeting minutes.<br>Coaching CRA from technical point.<br>Any other responsibilities and duties which may be required from time to time.<br><br>Supervision:<br>None<br><br>Main customers:<br>Internal customers:<br><br>All the internal colleagues in CRO, especially MED, MKT & Sales colleagues. The clinical operation colleagues in headquarters, IOCDC & other affiliates.<br>External customers:<br>All the healthcare professionals, officials. Especially the investigators in the clinical trials.<br><br>Education and Experience Requirements of the Position:<br>1.Bachelor's degree or above of Medical Science.<br>2.Rich working experience in conducting clinical trials.<br>3.Fluency English on both written & verbal.</p>
不限北京建国门外大街1号国贸大厦2座31层
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