- 目錄
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第1篇 臨床醫(yī)學(xué)專員崗位職責(zé)
臨床醫(yī)學(xué)專員/經(jīng)理 職位描述:
1.根據(jù)臨床試驗(yàn)要求,負(fù)責(zé)設(shè)計(jì)及報(bào)告撰寫階段的文獻(xiàn)檢索查詢相關(guān)醫(yī)學(xué)、藥信息和參考文獻(xiàn),提供相關(guān)信息;
2.參與臨床試驗(yàn)方案討論,撰寫或修改、病例報(bào)告表知情同意書等;
3.負(fù)責(zé)臨床研究總結(jié)報(bào)告的撰寫;
4.協(xié)助商務(wù)部門項(xiàng)目投標(biāo)的醫(yī)學(xué)支持、臨床試驗(yàn)研究方案摘要等相關(guān)文件撰寫。
任職要求 :
1.臨床醫(yī)學(xué) 、藥相關(guān)專業(yè)碩士學(xué) 歷,有醫(yī)學(xué)撰寫經(jīng)驗(yàn)者優(yōu)先;
2.英語(yǔ)讀寫流利,能夠熟練閱和翻譯醫(yī)學(xué)、藥方面專業(yè)文獻(xiàn);
3.能夠熟練使用醫(yī)學(xué)、藥專業(yè)文獻(xiàn)檢索工具;
4. 善于溝通,具有良好的團(tuán)隊(duì)合作精神。 職位描述:
1.根據(jù)臨床試驗(yàn)要求,負(fù)責(zé)設(shè)計(jì)及報(bào)告撰寫階段的文獻(xiàn)檢索查詢相關(guān)醫(yī)學(xué)、藥信息和參考文獻(xiàn),提供相關(guān)信息;
2.參與臨床試驗(yàn)方案討論,撰寫或修改、病例報(bào)告表知情同意書等;
3.負(fù)責(zé)臨床研究總結(jié)報(bào)告的撰寫;
4.協(xié)助商務(wù)部門項(xiàng)目投標(biāo)的醫(yī)學(xué)支持、臨床試驗(yàn)研究方案摘要等相關(guān)文件撰寫。
任職要求 :
1.臨床醫(yī)學(xué) 、藥相關(guān)專業(yè)碩士學(xué) 歷,有醫(yī)學(xué)撰寫經(jīng)驗(yàn)者優(yōu)先;
2.英語(yǔ)讀寫流利,能夠熟練閱和翻譯醫(yī)學(xué)、藥方面專業(yè)文獻(xiàn);
3.能夠熟練使用醫(yī)學(xué)、藥專業(yè)文獻(xiàn)檢索工具;
4. 善于溝通,具有良好的團(tuán)隊(duì)合作精神。
第2篇 臨床信息專員崗位職責(zé)任職要求
臨床信息專員崗位職責(zé)
臨床信息專員 1、客訴信息的接受、跟蹤、了解、分析。
2、客訴問(wèn)題和各部門及時(shí)溝通，在臨床角度給出產(chǎn)生客訴的可能
3、審查客訴診斷報(bào)告并給出到相關(guān)人員
4、必要時(shí)和客戶見(jiàn)面了解信息，給出客訴診斷。
5、在產(chǎn)品立項(xiàng)、研究等情況時(shí)，給出相關(guān)臨床意見(jiàn)
6、跟蹤新產(chǎn)品的動(dòng)物實(shí)驗(yàn)、臨床試驗(yàn)，試用、使用情況，并給出意見(jiàn)。
7、參與質(zhì)量改善，給出臨床方面意見(jiàn)
8、完成宣傳產(chǎn)品等其他相關(guān)任務(wù)。
要求10年以上外科醫(yī)生經(jīng)驗(yàn)，崗位相當(dāng)于技術(shù)顧問(wèn)，從醫(yī)生的角度給產(chǎn)品指導(dǎo)及根據(jù)反饋給出合理建議 1、客訴信息的接受、跟蹤、了解、分析。
2、客訴問(wèn)題和各部門及時(shí)溝通，在臨床角度給出產(chǎn)生客訴的可能
3、審查客訴診斷報(bào)告并給出到相關(guān)人員
4、必要時(shí)和客戶見(jiàn)面了解信息，給出客訴診斷。
5、在產(chǎn)品立項(xiàng)、研究等情況時(shí)，給出相關(guān)臨床意見(jiàn)
6、跟蹤新產(chǎn)品的動(dòng)物實(shí)驗(yàn)、臨床試驗(yàn)，試用、使用情況，并給出意見(jiàn)。
7、參與質(zhì)量改善，給出臨床方面意見(jiàn)
8、完成宣傳產(chǎn)品等其他相關(guān)任務(wù)。
要求10年以上外科醫(yī)生經(jīng)驗(yàn)，崗位相當(dāng)于技術(shù)顧問(wèn)，從醫(yī)生的角度給產(chǎn)品指導(dǎo)及根據(jù)反饋給出合理建議
臨床信息專員崗位
第3篇 臨床維護(hù)專員崗位職責(zé)
崗位職責(zé):負(fù)責(zé)客情關(guān)系的維護(hù)工作;負(fù)責(zé)產(chǎn)品的進(jìn)一步講解和臨床銷售;負(fù)責(zé)其余科室的宣傳維護(hù)工作;崗位要求:有過(guò)相關(guān)工作經(jīng)驗(yàn)者優(yōu)先,并且待遇優(yōu)厚!學(xué)醫(yī)或從事護(hù)理專業(yè)方面的優(yōu)先!
第4篇 cra臨床研究專員崗位職責(zé)
臨床研究專員/cra- 上海 達(dá)孜縣君合科技有限公司 達(dá)孜縣君合科技有限公司,君合醫(yī)藥,君合科技,君合 職位描述:
按照要求協(xié)助或負(fù)責(zé)i~iv 期臨床研究中的各項(xiàng)工作,對(duì)新藥研發(fā)流程及臨床研究相關(guān)法律法規(guī)有一定了解。在臨床研究經(jīng)理或項(xiàng)目經(jīng)理指導(dǎo)下,能夠負(fù)責(zé)研究中心的日常管理工作,獨(dú)立進(jìn)行監(jiān)查工作。
任職資格:
1. 臨床醫(yī)學(xué)、藥學(xué)或相關(guān)專業(yè)學(xué)歷,對(duì)藥品管理有關(guān)法規(guī)、臨床研究和臨床研究監(jiān)查流程有一定了解。
2. 一年以上臨床研究監(jiān)查工作經(jīng)驗(yàn),進(jìn)行過(guò)獨(dú)立的臨床研究監(jiān)查。
3. 具備一定的溝通表達(dá)能力、判斷能力、應(yīng)變能力及問(wèn)題解決能力。
4. 良好的寫作能力及組織能力,能夠根據(jù)工作分配的強(qiáng)度及優(yōu)先度進(jìn)行自我調(diào)整。
5. 積極主動(dòng)的工作態(tài)度,能適應(yīng)長(zhǎng)期出差。
6. 熟練的使用windows操作系統(tǒng)與office系列辦公軟件包括word、e_cel、powerpoint。
7. 具備一定的英語(yǔ)閱讀及寫作能力。
第5篇 臨床專員崗位職責(zé)
臨床專員 博毅雅(上海)醫(yī)療科技有限責(zé)任公司 博毅雅(上海)醫(yī)療科技有限責(zé)任公司,博毅雅 工作職責(zé):
1、 為客戶或部門內(nèi)部提供產(chǎn)品知識(shí)培訓(xùn)及臨床應(yīng)用培訓(xùn);
2、 協(xié)助產(chǎn)品推廣,向用戶現(xiàn)場(chǎng)演示和介紹產(chǎn)品、臨床應(yīng)用的方法;
3、 收集臨床資料和用戶需求反饋,研究總結(jié)臨床應(yīng)用優(yōu)勢(shì)和新的產(chǎn)品應(yīng)用領(lǐng)域。
4、 幫助銷售人員和代理商更好地理解產(chǎn)品的臨床應(yīng)用。
5、 與國(guó)內(nèi)、國(guó)外的業(yè)內(nèi)專家建立聯(lián)系,為公司產(chǎn)品開(kāi)發(fā)提供臨床理論支持。
任職資格:
1、具有醫(yī)學(xué)背景及臨床實(shí)踐背景;
2、善于溝通,有應(yīng)急事件處理能力,高度的責(zé)任感及對(duì)外協(xié)調(diào)能力。
3、較強(qiáng)的學(xué)習(xí)能力和上進(jìn)心心。
第6篇 臨床協(xié)調(diào)專員崗位職責(zé)
cra(臨床試驗(yàn)協(xié)調(diào)專員) 欣凱醫(yī)藥化工中間體 欣凱醫(yī)藥化工中間體(上海)有限公司,欣凱醫(yī)藥,欣凱醫(yī)藥化工中間體,欣凱 崗位職責(zé):
1.根據(jù)gcp及公司sop執(zhí)行臨床監(jiān)查工作;
2.確保試驗(yàn)嚴(yán)格按照方案、gcp及相關(guān)法律法規(guī)執(zhí)行;
3.協(xié)助研究中心解決試驗(yàn)過(guò)程中可能出現(xiàn)的問(wèn)題;
4.確保研究數(shù)據(jù)及時(shí)、準(zhǔn)確、完整地記錄在原始病歷中,病例報(bào)告表與原始病歷數(shù)據(jù)一致;
5.及時(shí)全面地匯報(bào)研究中心進(jìn)展情況;
6.完成相應(yīng)書面工作;
7.協(xié)助研究者及時(shí)完成數(shù)據(jù)疑問(wèn);
8.及時(shí)、完整地收集研究相關(guān)資料;
9.完成試驗(yàn)結(jié)束階段的藥品、資料整理與回收,關(guān)閉中心。
任職要求:
1. 臨床醫(yī)學(xué)、藥學(xué)等相關(guān)專業(yè)本科及本科以上學(xué)歷;有臨床風(fēng)濕病工作經(jīng)驗(yàn)優(yōu)先;
2. 一年以上臨床監(jiān)查工作經(jīng)驗(yàn);
3. 熟悉臨床試驗(yàn)監(jiān)查、fda、cfda法規(guī)、ich/gcp條例;
4.與人溝通、談判、表達(dá)能力較強(qiáng)。
第7篇 臨床銷售專員崗位職責(zé)任職要求
臨床銷售專員崗位職責(zé)
【長(zhǎng)沙_臨床微生物】客戶專員/銷售代表 responsibility:
-sales targets: actively complete assigned territory core instrument/reagent business sales tasks through field clinical communication in relevant departments of hospitals
-customer management: implement field clinical communication and utilize the bd academic platform and the speaker pools to influence the customers in territory for business.
-strictly abide by country compliance law and bd policy and rules.
-visit target customers regularly according to the specified scope and do the micro-market analysis for the assigned hospitals. target customer includes clinical laboratory director， micro-biology team leader， relevant clinical department doctors and nurses， infection & control department director， equipment director， vice president and president.
- make sales/marketing strategy against competitors together with marketing and as team.
-be participant into professional education branding establishment of ds， enhance self-capabilities， especially on knowledge of microbiology， to be an e_pert in microbiology industrial. responsibility:
-sales targets: actively complete assigned territory core instrument/reagent business sales tasks through field clinical communication in relevant departments of hospitals
-customer management: implement field clinical communication and utilize the bd academic platform and the speaker pools to influence the customers in territory for business.
-strictly abide by country compliance law and bd policy and rules.
-visit target customers regularly according to the specified scope and do the micro-market analysis for the assigned hospitals. target customer includes clinical laboratory director， micro-biology team leader， relevant clinical department doctors and nurses， infection & control department director， equipment director， vice president and president.
- make sales/marketing strategy against competitors together with marketing and as team.
-be participant into professional education branding establishment of ds， enhance self-capabilities， especially on knowledge of microbiology， to be an e_pert in microbiology industrial.
臨床銷售專員崗位
第8篇 臨床協(xié)調(diào)專員崗位職責(zé)任職要求
臨床協(xié)調(diào)專員崗位職責(zé)
崗位職責(zé):
1.根據(jù)gcp及公司sop執(zhí)行臨床監(jiān)查工作;
2.確保試驗(yàn)嚴(yán)格按照方案、gcp及相關(guān)法律法規(guī)執(zhí)行;
3.協(xié)助研究中心解決試驗(yàn)過(guò)程中可能出現(xiàn)的問(wèn)題;
4.確保研究數(shù)據(jù)及時(shí)、準(zhǔn)確、完整地記錄在原始病歷中，病例報(bào)告表與原始病歷數(shù)據(jù)一致;
5.及時(shí)全面地匯報(bào)研究中心進(jìn)展情況;
6.完成相應(yīng)書面工作;
7.協(xié)助研究者及時(shí)完成數(shù)據(jù)疑問(wèn);
8.及時(shí)、完整地收集研究相關(guān)資料;
9.完成試驗(yàn)結(jié)束階段的藥品、資料整理與回收，關(guān)閉中心。
任職要求:
1. 臨床醫(yī)學(xué)、藥學(xué)等相關(guān)專業(yè)本科及本科以上學(xué)歷;有臨床風(fēng)濕病工作經(jīng)驗(yàn)優(yōu)先;
2. 一年以上臨床監(jiān)查工作經(jīng)驗(yàn);
3. 熟悉臨床試驗(yàn)監(jiān)查、fda、cfda法規(guī)、ich/gcp條例;
4.與人溝通、談判、表達(dá)能力較強(qiáng)。
臨床協(xié)調(diào)專員崗位
第9篇 臨床學(xué)術(shù)專員崗位職責(zé)任職要求
臨床學(xué)術(shù)專員崗位職責(zé)
職責(zé)描述:
1、負(fù)責(zé)所轄區(qū)域肝病檢測(cè)項(xiàng)目的推廣和銷售工作;
2、根據(jù)公司銷售和開(kāi)發(fā)目標(biāo)，完成所轄區(qū)域的銷售和開(kāi)發(fā)目標(biāo);
3、負(fù)責(zé)客戶信息的收集和上報(bào)，完成客戶業(yè)務(wù)合同的簽訂;
4、負(fù)責(zé)所轄區(qū)域內(nèi)銷售活動(dòng)的策劃和執(zhí)行;
5、負(fù)責(zé)所轄區(qū)域內(nèi)的應(yīng)收賬款的回款及上級(jí)安排的其他相關(guān)工作。
任職要求:
1、醫(yī)學(xué)或營(yíng)銷類相關(guān)專業(yè);
2、從事醫(yī)療行業(yè)銷售工作1年以上，曾有過(guò)醫(yī)學(xué)檢測(cè)、肝病線藥品銷售相關(guān)經(jīng)驗(yàn)者優(yōu)先;
3、具備良好的溝通表達(dá)能力及團(tuán)隊(duì)合作精神;
4、勤奮敬業(yè)、工作熱情主動(dòng)、善于思考、執(zhí)行力強(qiáng)。
臨床學(xué)術(shù)專員崗位
第10篇 臨床醫(yī)學(xué)專員崗位職責(zé)要求
職位描述：
崗位職責(zé)：
1、醫(yī)學(xué)病歷撰寫、整理，影像資料的識(shí)別和分類；
2、客戶就醫(yī)完成后資料的整理和上傳，定期的隨訪跟蹤，跟蹤記錄的匯集和總結(jié)，指導(dǎo)進(jìn)一步檢查檢驗(yàn)；
3、高端客戶健康管理資料建立和方案制定；
4、負(fù)責(zé)通過(guò)檢索文獻(xiàn)獲得國(guó)外醫(yī)療前沿信息等；
5、公司領(lǐng)導(dǎo)安排的其他工作；
崗位要求：
1、臨床醫(yī)學(xué)或相關(guān)專業(yè)本科以上學(xué)歷，碩士以上優(yōu)先；
2、1年以上醫(yī)院臨床工作經(jīng)歷優(yōu)先；
3、英語(yǔ)讀寫能力較好，具備專業(yè)醫(yī)學(xué)文獻(xiàn)的檢索、閱讀和分析能力，具有方案、文章撰寫能力者優(yōu)先；
4、工作主動(dòng)，認(rèn)真負(fù)責(zé)，有較強(qiáng)的學(xué)習(xí)能力
第11篇 臨床事務(wù)專員崗位職責(zé)
臨床事務(wù)專員 1、檢索產(chǎn)品臨床相關(guān)信息(包括但不限于:產(chǎn)品的臨床試驗(yàn)情況、不良事件等);
2、負(fù)責(zé)產(chǎn)品說(shuō)明書編寫;
3、負(fù)責(zé)臨床試驗(yàn)機(jī)構(gòu)篩選;
4、負(fù)責(zé)與統(tǒng)計(jì)學(xué)專家和臨床專家溝通草擬臨床方案,及臨床方案的修改;
5、負(fù)責(zé)研究者手冊(cè)和/或臨床試驗(yàn)須知、知情同意書、病例報(bào)告表等相關(guān)臨床文件編寫和修改;
6、負(fù)責(zé)組織研究者(方案討論會(huì))會(huì)議;
7、協(xié)助cra與倫理委員會(huì)和臨床試驗(yàn)機(jī)構(gòu)溝通;
8、協(xié)助cra進(jìn)行臨床試驗(yàn)啟動(dòng)會(huì)準(zhǔn)備及研究者培訓(xùn);
9、負(fù)責(zé)匯總整理臨床試驗(yàn)產(chǎn)品使用性能反饋,并將反饋信息提交給項(xiàng)目經(jīng)理;
10、負(fù)責(zé)統(tǒng)計(jì)報(bào)告核查,確保統(tǒng)計(jì)報(bào)告符合臨床試驗(yàn)方案要求;
11、負(fù)責(zé)臨床總結(jié)報(bào)告編寫、與研究者溝通;
12、負(fù)責(zé)組織解決國(guó)家食品藥品監(jiān)督管理局醫(yī)療器械技術(shù)審評(píng)中心評(píng)審發(fā)補(bǔ)意見(jiàn)中臨床部分工作。 可接受應(yīng)屆畢業(yè)生 1、檢索產(chǎn)品臨床相關(guān)信息(包括但不限于:產(chǎn)品的臨床試驗(yàn)情況、不良事件等);
2、負(fù)責(zé)產(chǎn)品說(shuō)明書編寫;
3、負(fù)責(zé)臨床試驗(yàn)機(jī)構(gòu)篩選;
4、負(fù)責(zé)與統(tǒng)計(jì)學(xué)專家和臨床專家溝通草擬臨床方案,及臨床方案的修改;
5、負(fù)責(zé)研究者手冊(cè)和/或臨床試驗(yàn)須知、知情同意書、病例報(bào)告表等相關(guān)臨床文件編寫和修改;
6、負(fù)責(zé)組織研究者(方案討論會(huì))會(huì)議;
7、協(xié)助cra與倫理委員會(huì)和臨床試驗(yàn)機(jī)構(gòu)溝通;
8、協(xié)助cra進(jìn)行臨床試驗(yàn)啟動(dòng)會(huì)準(zhǔn)備及研究者培訓(xùn);
9、負(fù)責(zé)匯總整理臨床試驗(yàn)產(chǎn)品使用性能反饋,并將反饋信息提交給項(xiàng)目經(jīng)理;
10、負(fù)責(zé)統(tǒng)計(jì)報(bào)告核查,確保統(tǒng)計(jì)報(bào)告符合臨床試驗(yàn)方案要求;
11、負(fù)責(zé)臨床總結(jié)報(bào)告編寫、與研究者溝通;
12、負(fù)責(zé)組織解決國(guó)家食品藥品監(jiān)督管理局醫(yī)療器械技術(shù)審評(píng)中心評(píng)審發(fā)補(bǔ)意見(jiàn)中臨床部分工作。
第12篇 臨床研究項(xiàng)目專員崗位職責(zé)
臨床研究經(jīng)理-項(xiàng)目經(jīng)理-主管-專員 main tasks & responsibilities
1. contribute country specific aspects in the development of protocol, protocol revisions, amendments and crf design;
2. responsible for the management of designated sites in clinical trial including:
? site assessment;? preparation of the monitoring plan and e_ecution in compliance with visit frequency and all assigned tasks throughout the study;? planning and e_ecution of study logistics plan, including eventual delegation of activities to support group;? safety and proper conduct throughout the trial.
3. site specific data management;
4. prepare documentation for irb/ec submission/approval, together with study management per country specific requirements;
5. prepare and review clinical study agreements and budgets with study manager and contracts group;
6. ensure procedures are in place for appropriate enrollment of patients into the clinical trial;
7. organize investigator’s start-up meeting and study site initiation meetings, including training of the e_ternal study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with wincaev and training in the use of electronica crfs with remote data entry;8. responsible for instrument installation, check and validation (internal and e_ternal) for system study. if applicable, prepare workflow sheet for system studies, together with study management;
9. responsible for logistics of required evaluation/clinical trial material. informs and monitors sites for correct storage conditions;
10. preparation of all study binders;
11. perform investigator training (compliance & technical part).
12. verify the investigator follows the approved protocol and all gcp procedures;
13. verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study;
14. key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquire about patient inclusion/e_clusion criteria for ongoing trials;
15. ensure that observations during studies are correctly tracked and forwarded to the responsible departments in ____;
16. verify that source data/documents and other trial records are accurate, complete, and maintained. regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops;17. communicate deviations from the protocol, sops, gcp, and the applicable regulatory requirements to the investigator;
18. interprets and evaluates results with respect to the study goals and, if necessary, discuss with the site, the study manager, eg. interruption of the study or initiation of additional measurements at the e_ternal site;
19. perform troubleshooting for une_pected results according to study manager or protocol’s requirements;
20. ensure completion and availability of study documentation, together with study management;21. adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol;22. conduct study close-out visits according to monitoring plan;
23. ensure ecrf and wincaev are ready for database lock;
24. archive study records / database according to guidelines;
25. responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit;26. participation in project teams, global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability, practicability and sop development, to continuously improve quality and efficiency of the evaluation team and processes;
27. contribute to the content of the study report and contribute to publications for journals and congresses.
possible additional tasks for senior position holders;
28. responsible for investigator selection (accountability lies with study manager)
29. provide mentoring, including training on the job, to the new cras to ensure that their role and contribution is optimized.
basic requirements of the job
1. bio-medical related scientific degree; can vary from a bachelor, master and nursing qualifications;
2. knowledge of applicable standards an regulations for clinical trials and lab conduct (international conference on harmonization / who good clinical practice standards (ich-gcp), ivd directives, fda regulations)
3. practical e_perience in study monitoring according to global standards (ich)
4. 2-5 years of clinical laboratory e_perience;
5. demonstrated e_perience in computer skills to include microsoft word, e_cel, and basic templates;
6. basic statistical knowledge;
7. professional use of the english language; both written and oral;
8. open and clear communicator;
9. ability to make sound decisions and analyze and solve problems;
10. conscientious and precise delivery of work even when under pressure jd 為參考。經(jīng)理-專員各級(jí)別都有。
背景優(yōu)先級(jí):1 ivd 2 cro 3 器械 4 藥 main tasks & responsibilities
1. contribute country specific aspects in the development of protocol, protocol revisions, amendments and crf design;
2. responsible for the management of designated sites in clinical trial including:
? site assessment;? preparation of the monitoring plan and e_ecution in compliance with visit frequency and all assigned tasks throughout the study;? planning and e_ecution of study logistics plan, including eventual delegation of activities to support group;? safety and proper conduct throughout the trial.
3. site specific data management;
4. prepare documentation for irb/ec submission/approval, together with study management per country specific requirements;
5. prepare and review clinical study agreements and budgets with study manager and contracts group;
6. ensure procedures are in place for appropriate enrollment of patients into the clinical trial;
7. organize investigator’s start-up meeting and study site initiation meetings, including training of the e_ternal study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with wincaev and training in the use of electronica crfs with remote data entry;8. responsible for instrument installation, check and validation (internal and e_ternal) for system study. if applicable, prepare workflow sheet for system studies, together with study management;
9. responsible for logistics of required evaluation/clinical trial material. informs and monitors sites for correct storage conditions;
10. preparation of all study binders;
11. perform investigator training (compliance & technical part).
12. verify the investigator follows the approved protocol and all gcp procedures;
13. verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study;
14. key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquire about patient inclusion/e_clusion criteria for ongoing trials;
15. ensure that observations during studies are correctly tracked and forwarded to the responsible departments in ____;
16. verify that source data/documents and other trial records are accurate, complete, and maintained. regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops;17. communicate deviations from the protocol, sops, gcp, and the applicable regulatory requirements to the investigator;
18. interprets and evaluates results with respect to the study goals and, if necessary, discuss with the site, the study manager, eg. interruption of the study or initiation of additional measurements at the e_ternal site;
19. perform troubleshooting for une_pected results according to study manager or protocol’s requirements;
20. ensure completion and availability of study documentation, together with study management;21. adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol;22. conduct study close-out visits according to monitoring plan;
23. ensure ecrf and wincaev are ready for database lock;
24. archive study records / database according to guidelines;
25. responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit;26. participation in project teams, global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability, practicability and sop development, to continuously improve quality and efficiency of the evaluation team and processes;
27. contribute to the content of the study report and contribute to publications for journals and congresses.
possible additional tasks for senior position holders;
28. responsible for investigator selection (accountability lies with study manager)
29. provide mentoring, including training on the job, to the new cras to ensure that their role and contribution is optimized.
basic requirements of the job
1. bio-medical related scientific degree; can vary from a bachelor, master and nursing qualifications;
2. knowledge of applicable standards an regulations for clinical trials and lab conduct (international conference on harmonization / who good clinical practice standards (ich-gcp), ivd directives, fda regulations)
3. practical e_perience in study monitoring according to global standards (ich)
4. 2-5 years of clinical laboratory e_perience;
5. demonstrated e_perience in computer skills to include microsoft word, e_cel, and basic templates;
6. basic statistical knowledge;
7. professional use of the english language; both written and oral;
8. open and clear communicator;
9. ability to make sound decisions and analyze and solve problems;
10. conscientious and precise delivery of work even when under pressure
第13篇 臨床項(xiàng)目專員崗位職責(zé)
臨床項(xiàng)目啟動(dòng)專員ssu 北京斯丹姆賽爾技術(shù)有限責(zé)任公司 北京斯丹姆賽爾技術(shù)有限責(zé)任公司,斯丹姆賽爾 崗位職責(zé)
1.根據(jù)試驗(yàn)方案、合同規(guī)定的工作范圍、sop和gcp的要求進(jìn)行研究中心篩選、倫理遞交、合同談判和核心文件準(zhǔn)備等工作。
2.可同時(shí)負(fù)責(zé)多個(gè)項(xiàng)目、研究中心和治療領(lǐng)域內(nèi)的研究中心啟動(dòng)工作。
3.對(duì)所負(fù)責(zé)的研究中心進(jìn)行方案和研究相關(guān)的溝通,為項(xiàng)目篩選合適的研究中心。
4.負(fù)責(zé)研究中心臨床試驗(yàn)協(xié)議的談判與簽署工作。
5.負(fù)責(zé)協(xié)調(diào)研究中心啟動(dòng)所需核心文件的收集、審閱、批準(zhǔn)等工作。
6.負(fù)責(zé)研究中心倫理文件準(zhǔn)備、遞交、溝通等工作,并協(xié)助取得倫理批件。
7.協(xié)助研究中心啟動(dòng)前藥品及試驗(yàn)物資的準(zhǔn)備及分發(fā)工作。
8.通過(guò)追蹤注冊(cè)申報(bào)和批復(fù)、遞交及批準(zhǔn)文件的溝通信、電話溝通等,管理所負(fù)責(zé)研究中心的
進(jìn)展。
9.負(fù)責(zé)相應(yīng)研究中心啟動(dòng)階段的研究財(cái)務(wù)管理。
10.協(xié)助進(jìn)行項(xiàng)目的可行性調(diào)研。
11.與其他職能部門共同合作。
12.完成直線經(jīng)理和/或項(xiàng)目經(jīng)理(pm)分配的其他工作。
崗位要求
1.臨床醫(yī)學(xué)、藥理學(xué)、護(hù)理學(xué)、衛(wèi)生管理或其他相關(guān)專業(yè)的大專以上學(xué)歷。
2.1年以上臨床研究、臨床監(jiān)查、臨床項(xiàng)目啟動(dòng)或臨床協(xié)調(diào)員經(jīng)驗(yàn)。
3.良好的臨床研究知識(shí),了解相關(guān)的法規(guī)要求。
4.通過(guò)公司培訓(xùn),掌握方案要求的知識(shí)。
5.良好的計(jì)算機(jī)技能,包括熟練應(yīng)用微軟word、e_cel和powerpoint,以及熟練使用手提電腦。
6.良好的口頭和書面溝通能力。
第14篇 臨床數(shù)據(jù)專員職位描述與崗位職責(zé)任職要求
職位描述：
崗位職責(zé):
1. 參與數(shù)據(jù)庫(kù)和核查程序測(cè)試
2. 按照數(shù)據(jù)核查計(jì)劃核查數(shù)據(jù)，解決數(shù)據(jù)質(zhì)疑，對(duì)數(shù)據(jù)進(jìn)行清理
3. 進(jìn)行嚴(yán)重不良事件和外部數(shù)據(jù)的一致性核查
4. 準(zhǔn)備數(shù)據(jù)審閱會(huì)議資料，參與數(shù)據(jù)審核會(huì)議
5. 協(xié)助項(xiàng)目數(shù)據(jù)經(jīng)理進(jìn)行數(shù)據(jù)庫(kù)鎖定
6. 數(shù)據(jù)庫(kù)及相關(guān)管理文件的歸檔
7. 完成項(xiàng)目數(shù)據(jù)經(jīng)理分配的其余工作
任職要求：
1. 臨床醫(yī)學(xué)、護(hù)理學(xué)、藥學(xué)及相關(guān)專業(yè)?？埔陨蠈W(xué)歷（接受應(yīng)屆生）；
2. 良好的英語(yǔ)閱讀能力；
3. 工作認(rèn)真、負(fù)責(zé)、細(xì)心；
4. 有良好的表達(dá)溝通能力、學(xué)習(xí)能力和接受能力；
5. 了解和遵守核心的工作流程和工作指導(dǎo)；
第15篇 臨床信息專員崗位職責(zé)
臨床信息專員 風(fēng)和醫(yī)療器材 江蘇風(fēng)和醫(yī)療器材股份有限公司,fengh medical,江蘇風(fēng)和,風(fēng)和醫(yī)療,風(fēng)和醫(yī)療器材,風(fēng)和 1、客訴信息的接受、跟蹤、了解、分析。
2、客訴問(wèn)題和各部門及時(shí)溝通,在臨床角度給出產(chǎn)生客訴的可能
3、審查客訴診斷報(bào)告并給出到相關(guān)人員
4、必要時(shí)和客戶見(jiàn)面了解信息,給出客訴診斷。
5、在產(chǎn)品立項(xiàng)、研究等情況時(shí),給出相關(guān)臨床意見(jiàn)
6、跟蹤新產(chǎn)品的動(dòng)物實(shí)驗(yàn)、臨床試驗(yàn),試用、使用情況,并給出意見(jiàn)。
7、參與質(zhì)量改善,給出臨床方面意見(jiàn)
8、完成宣傳產(chǎn)品等其他相關(guān)任務(wù)。
第16篇 臨床項(xiàng)目專員崗位職責(zé)任職要求
臨床項(xiàng)目專員崗位職責(zé)
崗位職責(zé):
1、根據(jù)時(shí)間表管理臨床項(xiàng)目執(zhí)行層面的各項(xiàng)支持工作;
2、熟練使用科技手段支持臨床試驗(yàn)項(xiàng)目在ctms和etmf中的管理;
3、成為臨床試驗(yàn)管理系統(tǒng)的使用專家并承擔(dān)管理員職責(zé);
4、支持臨床試驗(yàn)團(tuán)隊(duì)進(jìn)行etmf的歸檔和整理;
5、負(fù)責(zé)與公司財(cái)務(wù)進(jìn)行項(xiàng)目相關(guān)乃至運(yùn)營(yíng)相關(guān)的溝通和操作;
6、支持項(xiàng)目經(jīng)理進(jìn)行供應(yīng)商管理;
7、組織各類研究者會(huì)議并統(tǒng)籌會(huì)務(wù)工作。
職位要求:
1、大學(xué)本科以上，醫(yī)藥相關(guān)專業(yè)，英文讀寫流利;
2、應(yīng)屆畢業(yè)生，有相關(guān)工作經(jīng)驗(yàn)者優(yōu)先;
3、具有計(jì)算機(jī)相關(guān)基礎(chǔ)知識(shí)，愿意學(xué)習(xí)新的線上程序和系統(tǒng)的應(yīng)用;
4、具有基本的藥物研發(fā)知識(shí)，基本了解臨床試驗(yàn)過(guò)程和對(duì)相關(guān)文件的要求;
5、 良好的溝通、表達(dá)和執(zhí)行能力，善于團(tuán)隊(duì)合作，認(rèn)真負(fù)責(zé)、嚴(yán)謹(jǐn)穩(wěn)健。
臨床項(xiàng)目專員崗位
