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

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