職位描述：

崗位職責:

1、研究中心篩選、啟動和臨床監查；

2、給中心人員提供關于GCP，研究方案和需求的持續培訓；

3、在研究的啟動進行和結束階段，根據方案和法規的要求，及時收集必要的文檔，及時更新研究者文件夾和TMF；

4、藥品管理；"

職位要求:

1、藥學或醫學相關專業本科及以上學歷；

2、至少1年CRA相關工作經歷；

3、對GCP及臨床試驗流程有一定了解；

4、英語水平良好，CET6；

5、能熟練的使用MicrosoftWord、Excel、PPT等辦公軟件；

6、認可公司敬業合作、正直誠信、實事求是、開放包容的價值觀。"

篇2:臨床監查項目崗位職責任職要求

臨床監查項目崗位職責

職責描述:

1.通過規范的監查過程,保證臨床試驗按國家GCP要求和試驗方案進行;

2.試驗用藥物和物品的正確保管、發放和使用;

3.填寫相關報告及試驗記錄,確保數據真實準確、完整無誤。

任職要求:

1.臨床醫學或醫藥學相關專業,本科及以上學歷;

2.2年以上CRA工作經驗;

3.熟悉藥品注冊管理辦法、藥品臨床試驗及GCP等相關法規;

4.具有良好的英文讀寫及口語能力;

5.有良好的人際關系和良好的溝通及語言表達能力;

6.能夠適應經常出差。

臨床監查項目崗位

篇3:臨床研究監查員崗位職責任職要求

臨床研究監查員崗位職責

臨床研究監查員(CRA)上海百利佳生醫藥科技有限公司上海百利佳生醫藥科技有限公司,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.

臨床研究監查員崗位