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更新于 12月1日
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臨床監(jiān)查員cra

1.2-2萬(wàn)
  • 廣州越秀區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

注冊(cè)藥物
1. Conduct clinical site management related work according to company Standard Operation Procedures (SOP), Good Clinical Practice (GCP), and other authority laws and regulations
2. Conduct and/or assist with site for study filling, initial EC submission/ EC opinion responds, clinical study agreement negotiation and others according to protocol and company SOPs
3. Acting as the main line of communication between the sponsor and the investigator accordance with contracted scope of work
4. Conduct site selection (if applicable), site initiation, routine monitoring and close-out visits in accordance with contracted scope of work
5. If applicable, may be accountable for supporting developing project subject recruitment plan on a per site basis. Work with sites to adapt, driving and tracking subject recruitment plan in line with project needs
6. Conduct monitoring visits and site management activities for a variety of protocols, sites and therapeutic areas
7. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
8. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
9. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution, safety information submission etc.
10. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
11. Build awareness of features and opportunities of study to site
12. Collaborate and liaise with study team members for project execution support as appropriate
13. Other works which line manager or company assigned
任職資格
Education:
? Major in clinical medicine/nurse/ pharmacy/ pharmacological or other related, clinical medicine/nurse was preferred
? At least bachelor's degree and above was preferred. or other equivalent education background
Experience:
? Previous working experience in clinical research related industry such as in hospital/medical institute/Contract Research Organization (CRO)/pharmaceutical or other similar
? At least 1year or above clinical trial working experience in CRO/Pharmaceutical company or equivalent experience

工作地點(diǎn)

廣州越秀區(qū)FOOPHOTOS商用圖片社(中華國(guó)際中心-A塔店)

職位發(fā)布者

劉圓夢(mèng)/人事經(jīng)理

三日內(nèi)活躍
立即溝通
公司Logo百試達(dá)(上海)醫(yī)藥科技股份有限公司
百試達(dá)（上海）醫(yī)藥科技股份有限公司成立于2010年，是一家國(guó)際化創(chuàng)新藥物臨床開(kāi)發(fā)機(jī)構(gòu)，已連續(xù)兩次榮獲上海市科委高新技術(shù)企業(yè)稱(chēng)號(hào)，服務(wù)范圍覆蓋全國(guó)多個(gè)中心城市和區(qū)域，下屬尚睿全資子公司，美國(guó)和澳大利亞控股子公司，現(xiàn)有員工已過(guò)千人。公司擁有資深專(zhuān)業(yè)研究團(tuán)隊(duì)，主要研究人員均具有外資制藥企業(yè)藥物研發(fā)部和臨床研究部工作經(jīng)驗(yàn)，具有國(guó)際化、標(biāo)準(zhǔn)化的業(yè)務(wù)運(yùn)作流程和科學(xué)嚴(yán)謹(jǐn)?shù)馁|(zhì)量保證體系，諳熟國(guó)際多中心臨床試驗(yàn)和國(guó)內(nèi)各種類(lèi)型臨床試驗(yàn)項(xiàng)目的運(yùn)作和管理。公司總部位于上海，在北京、南京、廣州、成都、武漢設(shè)有分支機(jī)構(gòu)，在美國(guó)波士頓及澳大利亞悉尼設(shè)有聯(lián)絡(luò)處和QA辦公室。百試達(dá)業(yè)務(wù)范圍包括臨床試驗(yàn)的設(shè)計(jì)、組織、運(yùn)作和管理，如I-IV期藥物臨床試驗(yàn)和醫(yī)療器械臨床試驗(yàn)項(xiàng)目的策劃和籌備、方案撰寫(xiě)、基地篩選、臨床監(jiān)查服務(wù)、藥物管理、數(shù)據(jù)管理和生物統(tǒng)計(jì)、研究報(bào)告撰寫(xiě)。公司還提供藥品和醫(yī)療器械注冊(cè)和醫(yī)學(xué)咨詢(xún)和代理、流行病學(xué)觀(guān)察性研究、醫(yī)藥市場(chǎng)研究和研究者、CRA和其他臨床研究專(zhuān)業(yè)人員的培訓(xùn)等。創(chuàng)新藥物研發(fā)包括化合物和大分子生物制品的篩選，活性藥物合成和制劑，化學(xué)藥物和生物藥品的國(guó)外專(zhuān)利技術(shù)的國(guó)內(nèi)轉(zhuǎn)化以及相應(yīng)的臨床開(kāi)發(fā)。此外，百試達(dá)還在臨床醫(yī)學(xué)，臨床藥理學(xué)和生物統(tǒng)計(jì)領(lǐng)域擁有一大批專(zhuān)家網(wǎng)絡(luò)資源，并通過(guò)高質(zhì)量的各類(lèi)人員和項(xiàng)目培訓(xùn)不斷擴(kuò)大這一網(wǎng)絡(luò)，從而保證各類(lèi)臨床項(xiàng)目的快速和高質(zhì)量的完成。公司的合作客戶(hù)包括知名跨國(guó)制藥公司和醫(yī)療器械企業(yè)、國(guó)內(nèi)研發(fā)型制藥企業(yè)、醫(yī)藥科研院所以及專(zhuān)業(yè)學(xué)術(shù)團(tuán)體等。
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