職位描述
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職位標(biāo)簽:
??臨床研究
職位職能:
??臨床研究員??
職位描述:
JOB TITLE: Clinical Research Associate
Location: Beijing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
1. Responsible for arranging the clinical trials, coordinating the selection of clinical hospital; preparation of EC documents; coordinating the establishment of clinical protocol; contacting the related person for clinical trials; ordering the reagents of clinical trials in time; No expired reagent because of personal negligence.
2. Responsible for coordinating the registration dossiers preparation (translating, notarizing, legislating) according to the requirements of SFDA. Urging, pushing and coordinating in each step of the registration, make sure that the steps would be finished within SFDA’s standard time limit, no delay in each steps.
3. Responsible for the QC testing, testing reagent/instrument ordering. No expired reagent because of personal negligence. Responsible for getting the final test report.
4. Responsible for document preparation and coordinate the QMS audit with QMS department.
5. Responsible for the local products new, renew, modify registration, following all the process of it until get the product license.
6. Complete main task in a timely manner.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB
Experience & Personality:
1. Good communication skills and learning ability.
2. Good sense of teamwork.
3. Strong sense of responsibility and good work attitude.
Education & Knowledge:
1. Bachelor degree or above in biology, clinical medicine or related subject priorities.
2. Good English skill including read and write.
3. Registration and clinical trial work experience in healthcare industry, IVD is preferred.
職位：臨床研究員
工作地點(diǎn)： 北京
主要職責(zé)和工作目標(biāo)
1. 負(fù)責(zé)梅里埃當(dāng)?shù)禺a(chǎn)品的注冊(cè)及與中國(guó)當(dāng)?shù)刈?cè)部門（國(guó)家食品藥品監(jiān)督管理局和上海市食品藥品監(jiān)督管理局）的聯(lián)系工作。
2. 負(fù)責(zé)安排臨床實(shí)驗(yàn)，協(xié)調(diào)臨床醫(yī)院與實(shí)驗(yàn)醫(yī)院的合作，編寫Protocal，并負(fù)責(zé)臨床實(shí)驗(yàn)過(guò)程中的相關(guān)事宜。
3. 根據(jù)國(guó)家食品藥品監(jiān)督管理局的要求，協(xié)調(diào)注冊(cè)卷宗的準(zhǔn)備工作（翻譯、公證、立法）。催促、推動(dòng)和協(xié)調(diào)注冊(cè)中的各環(huán)節(jié)的工作，確保每個(gè)環(huán)節(jié)工作在國(guó)家食品藥品監(jiān)督管理局規(guī)定的標(biāo)準(zhǔn)時(shí)限內(nèi)完成，不存在延遲現(xiàn)象。
4. 負(fù)責(zé)QC檢測(cè)，試劑檢測(cè)/儀器訂購(gòu)工作，防止因個(gè)人疏忽導(dǎo)致試劑過(guò)期現(xiàn)象，并獲取最終的測(cè)試報(bào)告。
5. 負(fù)責(zé)文件整理工作，并與質(zhì)量管理部門協(xié)調(diào)質(zhì)量管理體系審核工作。
6. 負(fù)責(zé)新產(chǎn)品的注冊(cè)、及老產(chǎn)品的二次注冊(cè)和變更登記工作，直至其獲得產(chǎn)品許可證。
具體知識(shí)和經(jīng)驗(yàn)要求
工作經(jīng)驗(yàn)和個(gè)人能力：
1. 良好的溝通能力和學(xué)習(xí)能力。
2. 良好的團(tuán)隊(duì)合作意識(shí)。
3. 高度的責(zé)任意識(shí)和良好的工作態(tài)度。
教育和知識(shí)要求：
1. 本科以上學(xué)歷，擁有相關(guān)專業(yè)生物學(xué)或醫(yī)學(xué)及相關(guān)專業(yè)者優(yōu)先。
2. 良好的英文讀寫能力。
3. 擁有醫(yī)療注冊(cè)和臨床試驗(yàn)工作經(jīng)驗(yàn)，IVD行業(yè)優(yōu)先。
