職位描述
藥品臨床監(jiān)查疫苗罕見病
職責要求：
· Bachelor degree in biological science or healthcare-related
field., or equivalent
· Less than 2-year experience as a clinical monitor, performed
all tasks for a CRA position or joined CRA trainee program or equivalence.
· Understanding of the clinical dataflow.
· Good knowledge of the clinical study and drug development processes,
GCP/ICH guidelines and relevant local regulations.
· Good computer skills in Microsoft and other
software.
· Fluent in both oral and written English.
· Proficient written and verbal communication skills, collaboration and
interpersonal skills.
- Drive study performance at the sites. Perform
site monitoring and other onsite visit activities according to monitoring
plan and in compliance with procedural documents. Provide the required
monitoring visit reports within required timelines. Proactively identify
study-related issues and escalates to Local Study Teams as appropriate. - Contribute to the selection of potential sites
and investigators. Train, support and advise Investigators and site staff
in study related matters. - Obtain and maintain essential documentation in
compliance with ICH-GCP, Procedural Documents and local regulations.
Manage study supplies (ISF, CRF, etc), drug supplies and drug
accountability at study sites. - Perform source data verification according to SDV
plan. Ensure data query resolution. Work with data management to ensure
quality of the study data. - Ensure accurate and timely reporting of Serious
Adverse Events. - Share relevant information on patient recruitment
and study site progress within local Study Team. Update VCV and other
systems with data from centres as per required timelines. - Prepare for activities associated with audits and regulatory
inspections in liaison with local Study Team Lead and QA.
· Bachelor degree in biological science or healthcare-related
field., or equivalent
· Less than 2-year experience as a clinical monitor, performed
all tasks for a CRA position or joined CRA trainee program or equivalence.
· Understanding of the clinical dataflow.
· Good knowledge of the clinical study and drug development processes,
GCP/ICH guidelines and relevant local regulations.
· Good computer skills in Microsoft and other
software.
· Fluent in both oral and written English.
· Proficient written and verbal communication skills, collaboration and
interpersonal skills.
工作地點
廣州越秀區(qū)江灣商業(yè)中心
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職位發(fā)布者
董雅喬/招聘經(jīng)理
立即溝通
上?？档潞胍磲t(yī)學臨床研究有限公司康德弘翼（WuXi Clinical），是藥明康德（WuXi AppTec）的一家全資子公司。始終致力為全球客戶提供全方位的臨床研究服務(wù)，包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗。通過嚴格的質(zhì)量控制體系和專業(yè)團隊的豐富經(jīng)驗，幫助創(chuàng)新性，突破性醫(yī)藥產(chǎn)品盡快上市和造?；颊??？档潞胍砹⒆阒袊嫦蚴澜?，以上?？偛繛橹行?，輻射全球制藥公司、生物技術(shù)公司以及醫(yī)療器械公司。目前，公司實行全球聯(lián)合運營，人員規(guī)模達850+人，運營能力覆蓋中國、美國及澳大利亞等，并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團隊與各研究中心建立了良好的合作關(guān)系，始終保持著緊密的業(yè)務(wù)交流，保證了項目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展，康德弘翼進一步完善和增強了全球一體化研發(fā)服務(wù)平臺的綜合實力，助力全球創(chuàng)新合作伙伴更好、更快地開發(fā)醫(yī)藥產(chǎn)品。
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