職位描述：

崗位職責(zé):

1、研究中心篩選、啟動(dòng)和臨床監(jiān)查；

2、給中心人員提供關(guān)于GCP，研究方案和需求的持續(xù)培訓(xùn)；

3、在研究的啟動(dòng)進(jìn)行和結(jié)束階段，根據(jù)方案和法規(guī)的要求，及時(shí)收集必要的文檔，及時(shí)更新研究者文件夾和TMF；

4、藥品管理；"

職位要求:

1、藥學(xué)或醫(yī)學(xué)相關(guān)專業(yè)本科及以上學(xué)歷；

2、至少1年CRA相關(guān)工作經(jīng)歷；

3、對(duì)GCP及臨床試驗(yàn)流程有一定了解；

4、英語水平良好，CET6；

5、能熟練的使用MicrosoftWord、Excel、PPT等辦公軟件；

6、認(rèn)可公司敬業(yè)合作、正直誠信、實(shí)事求是、開放包容的價(jià)值觀。"

篇2:臨床監(jiān)查項(xiàng)目崗位職責(zé)任職要求

臨床監(jiān)查項(xiàng)目崗位職責(zé)

職責(zé)描述:

1.通過規(guī)范的監(jiān)查過程,保證臨床試驗(yàn)按國家GCP要求和試驗(yàn)方案進(jìn)行;

2.試驗(yàn)用藥物和物品的正確保管、發(fā)放和使用;

3.填寫相關(guān)報(bào)告及試驗(yàn)記錄,確保數(shù)據(jù)真實(shí)準(zhǔn)確、完整無誤。

任職要求:

1.臨床醫(yī)學(xué)或醫(yī)藥學(xué)相關(guān)專業(yè),本科及以上學(xué)歷;

2.2年以上CRA工作經(jīng)驗(yàn);

3.熟悉藥品注冊(cè)管理辦法、藥品臨床試驗(yàn)及GCP等相關(guān)法規(guī);

4.具有良好的英文讀寫及口語能力;

5.有良好的人際關(guān)系和良好的溝通及語言表達(dá)能力;

6.能夠適應(yīng)經(jīng)常出差。

臨床監(jiān)查項(xiàng)目崗位

篇3:臨床研究監(jiān)查員崗位職責(zé)任職要求

臨床研究監(jiān)查員崗位職責(zé)

臨床研究監(jiān)查員(CRA)上海百利佳生醫(yī)藥科技有限公司上海百利佳生醫(yī)藥科技有限公司,百利佳生PositionDescription:

TheClinicalResearchAssociate(CRA)isresponsibleformanagingandmonitoringtheconductofclinicalprojectsaccordingtoICH-GCP,StandardOperatingProcedures(SOP)andapplicableProjectManagementPlan(PMP)andlocalregulatoryrequirements.

Responsibilities:

Contributecomments/inputinthedevelopmentofProtocol,InformedConsentForm(ICF),CaseReportForms(CRF)andotherprojectrelateddocuments.

EvaluationpotentialsiteswiththeassistancefromtheseniorCRA,PMorlinemanagerandprovidePMwithrecommendationsforselectionofqualifiedsites.

Preparethepackageforinstitutionalreviewboards(IRB)andlocalregulatoryauthoritysubmissionsandobtainIRB/regulatoryapprovalsforconductingtheclinicaltrial.

AssistPMinstart-upmeeting.

Prepareandmanagetheclinicaltrialagreementswithinvestigators/sites.

Track,manageandcontrolthesitebudgetandexpenseswithinapprovedbudgetandinlinewiththeprojectmilestonesasrequested.

Manage/coordinatetheinvestigationalproductsandclinicaltrialmaterialsforthesitesincompliancewithregulatoryrequirements.

Monitorandreporttheprojectstatusatthesitesinatimelymanner.

Keycontactpersonforthecommunicationbetweenthesitesandstudyteam.

Prepare,arrangeandconductthetrainingofsitepersonnel.

Conductsiteinitiation,monitoringandsiteclose-outvisitsincompliancewithmonitoringplan,ICH-GCP,SOPs,localregulationsandotherapplicableproject-specificplans.

PreparemonitoringreportaccordingtotheSOP.

Assisttheinvestigatorforauditing/inspectionofproject.

Coordinatewiththesitestoensurealladverseeventsandfollow-upareappropriatelyreportedandreconciledaccordingtoregulations.

Identify,analyzeandresolvetheissuesattheinvestigatorsites.

Qualifications:

A1-yearBS(BachelorofScience)degreeorequivalenceexperience.Advanceddegreeisaplus.

Atleast1yearexperienceinclinicalresearchenvironment.

GoodcommandofwrittenandspokeninEnglishorothersecondlanguage.

Goodorganizationandcommunicationskills.

Highattentiontodetailandaccuracy.

臨床研究監(jiān)查員崗位