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阿斯利康制药有限公司 Clinical Research Associate 申请该职位 查阅该职位薪酬水平
工作性质: 全职 工作地点: 广州市
发布日期: 2021-05-06 11:21:52 薪  水:
招聘人数: 1人 工作经验: 2年以上
学  历: 本科
职位描述:
1.Site Selection/Initiation Assist/conduct in potential investigator identification;Identify site staff/facility qualification according to GCP, SOPs and regulatory requirements;Identify issues/problems for resolution by project leader 2.Site Initiation Submit regulatory documents to IEC as required;Co-ordinate shipment and review storage/dispensing of IP and other study related materials;Assist and attend investigator meeting;Negotiate CSA & FA with investigators;Conduct site initiation visits 3.Study Monitoring On-site: Review overall site performance;Ensure investigator's adherence to protocol and GCP;Review Informed Consent Forms;Perform source data verification;Review SAE reports and make sure reporting procedures following to SOP, GCP;Review query resolution;Ensure IP accountability and review IP storage condition;Review regulatory documents;Identify site problems and take action accordingly In-house: Prepare site visit reports;Maintain regular telephone contact with investigators;Maintain and update study files;Maintain written correspondence with site;Track investigator payment;Assist query resolution 4.Study Termination Resolve queries;Retrieve CRFs;Ensure regulatory documents available and updated;Ensure IP, study material accountability, return and disposal if required;Ensure study report submission to EC;Ensure final payment processed to investigators;Resolve outstanding issues 5.Update IMPACT IMPACT update for responsible sites 6.Perform administrative duties Attendance project meeting, monitors meeting as required 7.Compliance duties Identify and record quality problems for solution 8.Others Perform other tasks assigned by supervisor Requirement: 1.Bachelor degree of Science or above,medical /pharmacological background desired 2.Basic GCP knowledge 3.At least 1-2 years working experience in clinical research in hospital/medical institute/or pharmaceutical industry 4.Fluent English in reading, writing and speaking 5.Familiar with MS office software( Word, Excel, powerpoint,etc.) 6.Work at sites and travel frequently 7.Strong Communication skill 8.Self motivated 9.Team work spirit
企业介绍:
公司简介 阿斯利康是全球领先制药公司之一,总部位于英国伦敦,研发总部位于瑞典,在全球设有11个研发中心、31个生产基地,产品销售覆盖100多个国家和地区,在心血管、消化、呼吸、麻醉、肿瘤和中枢神经领域处于领先地位。 阿斯利康中国总部位于上海,致力于寻求灵感创意,研制安全有效的药物,探索挽救生命的方法,将之带给广大患者。这些灵感来自于我们的优秀员工。所以我们始终坚持聘用最优秀的员工加入我们的队伍。
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