二级监查员岗位职责要求
二级监查员职位要求
1.预防医学（公共卫生）、临床医学、药学类、生物技术等医学相关专业。
2.本科及以上学历，要求有2年以上临床研究经验的，有外企药厂研究项目经验优先。
3.须通过英语四级，熟练运用Office办公软件。
4.工作认真负责，有耐心，能吃苦耐劳。
二级监查员岗位职责
1.试验前确认研究单位及研究者。
2.在试验前取得所有受试者的知情同意书，了解试验的进展状况。
3.核查所有数据的记录与报告正确完整性，监查所有病例报告表是否正确填写，并确保与原始资料一致。
4.进行必要的常规监查访视，协助进行必要的通知和沟通事宜。
5.确认所有不良事件在规定时间内作出报告并记录在案。
6.核实试验用品按照有关法规进行供应、储藏、分发、收回，并做相应的记录。
7.每次访视后做书面报告文件递送申办者，报告应述明监查日期、时间、监查员姓名、监查的发现等。
篇2：研究监查员岗位职责任职要求
研究监查员岗位职责
临床研究监查员(CRA)上海百利佳生医药科技有限公司上海百利佳生医药科技有限公司,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.
研究监查员岗位
篇3：研究监查岗位职责任职要求
研究监查岗位职责
临床研究监查员(CRA)上海百利佳生医药科技有限公司上海百利佳生医药科技有限公司,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.
研究监查岗位
篇4：研究监查员CRA岗位职责任职要求
研究监查员CRA岗位职责
临床研究监查员(CRA)上海百利佳生医药科技有限公司上海百利佳生医药科技有限公司,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.
研究监查员CRA岗位
篇5：二级销售岗位职责任职要求
二级销售岗位职责
岗位职责:
1、根据公司总体战略,结合市场情况制定针对军工行业的销售策略与规划并组织实施,达成销售目标;
2、协调组织所辖行业销售资源,督导销售目标的完成情况,并对部门成员进行销售目标的量化考核;
3、提供市场趋势、需求变化、竞争对手和客户反馈方面的准确信息,为公司制定销售策略及营销计划提供支持;
4、关注行业动态,收集市场信息、竞争对手和客户需求分析。
任职要求:
1、本科及以上历,电子、电气、通信类相关专业毕业。
2、5年以上数据中心产品军工行业销售经验,对军工行业有清晰了解,有一定的人脉资源。
4、富有激情,执行力强,具有强烈的目标达成意识。岗位职责:
1、根据公司总体战略,结合市场情况制定针对军工行业的销售策略与规划并组织实施,达成销售目标;
2、协调组织所辖行业销售资源,督导销售目标的完成情况,并对部门成员进行销售目标的量化考核;
3、提供市场趋势、需求变化、竞争对手和客户反馈方面的准确信息,为公司制定销售策略及营销计划提供支持;
4、关注行业动态,收集市场信息、竞争对手和客户需求分析。
任职要求:
1、本科及以上历,电子、电气、通信类相关专业毕业。
2、5年以上数据中心产品军工行业销售经验,对军工行业有清晰了解,有一定的人脉资源。
4、富有激情,执行力强,具有强烈的目标达成意识。
二级销售岗位
制度专栏
