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fzh3848107金虫 (著名写手)
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科文斯医药研发（北京）有限公司上海分公司
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职位详情 单位介绍 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. Covance's ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! Responsibilities: May serve as lead monitor for a protocol or project & assist in establishing monitoring plans. Review progress of projects & initiate appropriate actions to achieve target objectives. Organize/make presentations at Investigator Meetings. Report, write narratives and follow-up on serious adverse experiences. Interact with internal work groups to evaluate needs, resources and timelines. Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned. On-Site Monitoring Responsibilities: Ensure that study staff has received the proper materials and instructions. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines. Prepare accurate and timely trip reports. Qualifications: Minimum of two 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. University/college degree (life science preferred), or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology). 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, interpersonal, analytical and negotiation skills. Computer competency. Fluent in Chinese and in English, both written and verbal. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. 单位介绍 Covance ― one of the world's largest and most comprehensive drug development services companies ― has the people, global resources and problem-solving culture to respond to pharmaceutical and biotechnology clients' toughest drug development challenges. Currently, we have more than 8900 employees in >> 查看详情 Covance ― one of the world's largest and most comprehensive drug development services companies ― has the people, global resources and problem-solving culture to respond to pharmaceutical and biotechnology clients' toughest drug development challenges. Currently, we have more than 8900 employees in the worldwide and more than 300 employees in APAC. We provide a portfolio of preclinical and clinical development and commercial service offerings ― delivered through industry-leading nonclinical testing services, the world's largest central laboratory network, and a global team of clinical trial professionals. Visit our website at www.covance.com to learn 本单位正在招聘的职位： Clinical Trial Assistant | 临床研究专员II Clinical Research Associate II (CRA2) | Project Coordinator | Research Administration Coordinator | 临床研究专员II Clinical Research Associate II | >>更多 联系方式 联系地址：张江李冰路151号6号研发楼1楼 联系人：vicky.qu 联系电话： 电子邮箱： vicky.qu@covance.com |
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fzh3848107
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