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阿斯利康制藥有限公司 Clinical Research Associate 申請該職位 查閱該職位薪酬水平
工作性質: 全職 工作地點: 廣州市
發布日期: 2024-01-05 12:15:59 薪  水:
招聘人數: 1人 工作經驗: 2年以上
學  歷: 本科
職位描述:
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
企業介紹:
公司簡介 阿斯利康是全球領先制藥公司之一,總部位于英國倫敦,研發總部位于瑞典,在全球設有11個研發中心、31個生產基地,產品銷售覆蓋100多個國家和地區,在心血管、消化、呼吸、麻醉、腫瘤和中樞神經領域處于領先地位。 阿斯利康中國總部位于上海,致力于尋求靈感創意,研制安全有效的藥物,探索挽救生命的方法,將之帶給廣大患者。這些靈感來自于我們的優秀員工。所以我們始終堅持聘用最優秀的員工加入我們的隊伍。
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