临床监察员专业术语和职位英文描述

1、缩略语英文全称 中文全称ade adversedrugevent 药物不良事件adr adversedrugreaction药物不良反应aeadverseevent不良事件ai assistantinvestigator助理研究者bmi bodymassindex体质指数ci coinvestigator 合作研究者coi coordinatinginvestigator 协调研究者craclinicalresearchassociate 临床监查员（临床监察员）crc clinicalresearchcoordinator 临床研究协调者crf casereportform 病历报告表cro

2、 contractresearchorganization 合同研究组织csaclinicalstudyapplication 临床研究申请ctaclinicaltrialapplication 临床试验申请ctx clinicaltrialexemption 临床试验免责ctp clinicaltrialprotocol 临床试验方案ctr clinicaltrialreport 临床试验报告dsmbdatasafetyandmonitoringboard数据安全及监控委员会edc electronicdatacapture 电子数据采集系统edp electronicdataprocess

3、ing 电子数据处理系统fda foodanddrugadministration 美国食品与药品管理局fr finalreport 总结报告gcp goodclinicalpractice 药物临床试验质量管理规范glp goodlaboratorypractice 药物非临床试验质量管理规范gmpgoodmanufacturingpractice 药品生产质量管理规范ib investigatorsbrochure 研究者手册ic informedconsent 知情同意icf informedconsentform 知情同意书ich internationalconferenceonha

4、rmonization国际协调会议idm independentdatamonitoring 独立数据监察idmc independentdatamonitoringcommittee独立数据监察委员会iec independentethicscommittee 独立伦理委员会ind investigationalnewdrug 新药临床研究irb institutionalreviewboard 机构审查委员会ivd invitrodiagnostic 体外诊断ivrs interactivevoiceresponsesystem互动语音应答系统ma marketingapproval/au

5、thorization上市许可证mca medicinescontrolagency 英国药品监督局mhw ministry of health and welfare 日 本 卫 生 福 利 部 nda new drugapplication 新药申请nec newdrugentity 新化学实体nih nationalinstitutesofhealth 国家卫生研究所（美国）pi principalinvestigator 主要研究者pl productlicense 产品许可证pma premarketapprovalapplication上市前许可（申请）psi statistici

6、ansinthepharmaceuticalindustry 制药业统计学家协会qa qualityassurance 质量保证qc qualitycontrol 质量控制ra regulatoryauthorities 监督管理部门sa siteassessment 现场评估sae seriousadverseevent 严重不良事件sap statisticalanalysisplan 统计分析计划 药物临床试验网受试者招募sar seriousadversereaction 严重不良反应sd sourcedata/document 原始数据/文件sd subjectdiary 受试者日记

7、sfda statefoodanddrugadministration国家食品药品监督管理局sdv sourcedataverification 原始数据核准sel subjectenrollmentlog 受试者入选表si subinvestigator 助理研究者si sponsorinvestigator 申办研究者sic subjectidentificationcode 受试者识别代码sop standardoperatingprocedure 标准操作规程spl studypersonnellist 研究人员名单ssl subjectscreeninglog 受试者筛选表tampr

8、 testandreferenceproduct 受试和参比试剂uae unexpectedadverseevent 预料外不良事件who worldhealthorganization 世界卫生组织whoicdra whointernationalconferenceofdrugregulatoryauthoritieswho 国际药品管理当局会议activecontrol 阳性对照、活性对照audit 稽查auditreport 稽查报告auditor 稽查员blankcontrol 空白对照blinding/masking 盲法/设盲casehistory 病历clinicalstudy

9、 临床研究clinicaltrial 临床试验clinicaltrialreport 临床试验报告compliance 依从性coordinatingcommittee 协调委员会crossoverstudy 交叉研究doubleblinding 双盲endpointcriteria/measurement 终点指标essentialdocumentation 必需文件exclusioncriteria 排除标准inclusioncriteria 入选标准informationgathering 信息收集initialmeeting 启动会议inspection 检察/视察 copyright

10、institutioninspection 机构检察investigationalproduct 试验药物investigator 研究者monitor 监查员（监察员）monitoring 监查（监察）monitoringplan 监查计划（监察计划）monitoringreport 监查报告（监察报告）multicentertrial 多中心试验nonclinicalstudy 非临床研究originalmedicalrecord 原始医疗记录outcomeassessment 结果评价patientfile 病人档案patienthistory 病历placebo

11、安慰剂 创始人袁旭placebocontrol 安慰剂对照preclinicalstudy 临床前研究protocol 试验方案protocolamendments 修正案randomization 随机referenceproduct 参比制剂samplesize 样本量、样本大小seriousness 严重性severity 严重程度singleblinding 单盲sponsor 申办者studyaudit 研究稽查subject 受试者subjectenrollment 受试者入选subjectenrollmentlog 受试者入选表subjectidentificationcodel

12、ist 受试者识别代码表subjectrecruitment 受试者招募studysite 研究中心subjectscreeninglog 受试者筛选表systemaudit 系统稽查testproduct 受试制剂trialinitialmeeting 试验启动会议trialmasterfile 试验总档案trialobjective 试验目的tripleblinding 三盲washout 洗脱washoutperiod 洗脱期introductionquintiles transnational corp. helps improve healthcare worldwide by pr

13、oviding abroad range of professional services information and partnering solutions to thepharmaceutical biotechnology and healthcare industries. quintiles helps itscustomers compress the time it takes to bring a drug from discovery throughregulatory approval accelerate the launch of products to peak

14、 sales build effectivesales forces and manage product portfolios more efficiently and achieve strategic andfinancial objectives by offering tailored alternatives to traditional fee-for-serviceproduct development and commercial services agreements. headquartered nearresearch triangle park north carol

15、ina quintiles was founded in 1982 and has morethan 16000 employees and offices in over 50 countries. quintiles medicaldevelopment shanghai co. ltd. is a wholly owned subsidiary of quintilestransnational corp. further information please visit our global website job title:clinical project manager临床项目经

16、理responsibilitiesmanage and coordinate efforts of crossfunctional project teams to support milestoneachievementandtomanagestudyissuesandobstaclesandensureconsistentuseofstudytoolsandtrainingmaterialsandcompliancewithstandardprocessespoliciesandprocedures.develop study management plans together with

17、team assignments and accountabilities andoversightofdatabasemaintenance.serve as primary project contact with sponsor to ensure communication is maintained andreportingschedulesareadheredto.collectinformationonteamperformanceagainstcontractcustomerexpectationsandprojectbaselines.lead problem solving

18、 and resolution efforts to include management of risk contingencies andissues.identify quality issues within the study to implement appropriate corrective action plans.escalatefindingsandactionplanstoappropriateparties.provideinputforthedevelopmentofproposalsfornewworkandmanageprojectbudgets.provide

19、inputtolinemanagersoftheirprojectteammembersperformancerelativetoprojecttasks.prepareandpresentprojectinformationatinternalandexternalmeetings.participate in proposal development and in the biddefense process with guidance andsupervision.ensure high performance and efficiency of the clinical team th

20、rough the scheduling ofcomonitoring/accompaniedsite/visitsandongoingmentoringofcrateam.requiredknowledgeskillsandabilitiesindepthknowledgeofandskillinapplyingapplicableclinicalresearchregulatoryrequirementsi.e.goodclinicalpracticegcpandinternationalconferenceonharmonisationichguidelinesgoodtherapeut

21、icandprotocolknowledgestrongcommunicationandinterpersonalskillsincludinggoodcommandofenglishlanguagegoodproblemsolvingskillsdemonstratedabilitytodeliverresultstotheappropriatequalityandtimelinemetricsgoodteamworkskillsexcellentcustomerserviceskillsgoodpresentationskillsgoodjudgmentstrongsoftwareandc

22、omputerskillsincludingmsofficeapplicationsabilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkersmanagersandclientsminimumrequirededucationandexperiencebachelors degree in life sciences or related field and 5 years clinical research experienceincluding 2 years project management expe

23、rience and experience in clinical operations orequivalentcombinationofeducationtrainingandexperience.jobtitle:clinicaltrialsassistantlocation:beijingresponsibilitiesassist clinical team lead ctl and clinical research associates cras with accurately updating andmaintaining clinical systems that track

24、 site compliance and performance within project timelines.assist the clinical team in the preparation handling distribution filing and archiving of clinicaldocumentation and reports according to the scope of work and standard operating procedures. assistwith periodic review of study files for accura

25、cy and completeness.assist ctls with preparation handling and distribution of clinical trial supplies and maintenance oftracking information.assist with the tracking and management of case report forms crfs queries and clinical data flow.act as a central contact for the clinical team for designated

26、project communications correspondence andassociated documentation.may perform assigned administrative tasks to support team members with clinical trial execution.all responsibilities are essential job functions unless noted as nonessential n.required knowledge skills and abilitiesawareness of knowle

27、dge of applicable clinical research regulatory requirements i.e. good clinicalpractice gcp and international conference on harmonisation ich guidelinesknowledge of applicable protocol requirements as provided in company trainingcomputer skills including proficiency in use of microsoft word excel and

28、 powerpointstrong written and verbal communication skills including good command of english languageeffective time management and organizational skillsattention to detail and accuracy in workability to establish and maintain effective working relationships with coworkers managers and clientsminimum

29、required education and experienceschool diploma/certificate or educational equivalent or equivalent combination of education training andexperiencejobtitle:clinicalresearchassistantdescriptionquintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish noto

30、nly whether a drug is effective but who can take it safely. our customers have relied on us to designand conduct rigorous clinical research for decades from small studies to multinational mega-trials.however we continue to develop new ways of interpreting and evaluating data that allow us to createm

31、ore effective trials and determine outcomes faster.if that is your passion we have a place for you.job responsibilities:- oversees the progress of a clinical trial ensuring that it is conducted recorded and reported inaccordance with the protocol standard operating procedures sops good clinical prac

32、tice gcp andthe applicable regulatory requirements.- administer protocol and related study training to assigned site.- establish regular lines of communication with sites to manage ongoing project expectations and issues.qualificationsrequirements:- degree in science with a major in pharmacy biologi

33、cal / life sciences or nursing from a recognizedtertiary institution- minimum 1 year of clinical monitoring experience in the pharmaceutical / cro industry.- for senior research associate position minimum 3 years clinical monitoring experience preferablywith some experience in leading clinical teams

34、 in the region- good knowledge of drug development process clinical trial monitoring procedures medical terminologyand gcp/ich guidelines- excellent organizational and problem solving skills- strong written and verbal communication skills- ability to travel when requiredjobtitle:seniorclinicalprojec

35、tmanagerdescriptionquintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish notonly whether a drug is effective but who can take it safely. our customers have relied on us to designand conduct rigorous clinical research for decades from small studies to

36、 multinational mega-trials.however we continue to develop new ways of interpreting and evaluating data that allow us to createmore effective trials and determine outcomes faster.if that is your passion we have a place for you.responsibilities- manage and co-ordinate efforts of cross-functional proje

37、ct teams to support milestone achievement andto manage study issues and obstacles. ensure consistent use of study tools and training materials andcompliance with standard processes policies and procedures. implement continuous improvementactivities for assigned projects.- develop study management pl

38、ans together with team assignments and accountabilities and oversightof database maintenance.- serve as primary project contact with sponsor to ensure communication is maintained and continuouslyimproved and reporting schedules are adhered to.- report on team performance against contract customer ex

39、pectations and project baselines tomanagement.- lead problem solving and resolution efforts to include management of risk contingencies and issues.develop proactive contingency plans to mitigate clinical risk.- identify quality issues within the study through regular review of site communications mo

40、nitoring visitreports data flow information and quality assurance audit findings to implement appropriate correctiveaction plans. escalate findings and action plans to appropriate parties.- collaborate with other functional groups within the company where necessary to support milestoneachievement an

41、d to manage study issues and obstacles.- provide input for the development of proposals for new work and project budgets.- provide input to line managers of their project team members performance relative to project tasks.recommend team members further professional development. support staff develop

42、ment. mentor lessexperienced cpms.- ensure high performance and efficiency of the clinical team through the scheduling ofco-monitoring/accompanied site visits and ongoing mentoring of cra team.- prepare and present project information at internal and external meetings.- participate in proposal devel

43、opment. may lead bid defense presentations in partnership with businessdevelopment and senior clinical project management staff.- define project workloads and assignments. develop and oversee maintenance of internal databasesand project plansqualifications- bachelors degree in life sciences or relat

44、ed field and 7 years clinical research experience including 4years project management experience and experience in clinical operations or equivalent combination ofeducation training and experience.- in depth knowledge of and skill in applying applicable clinical research regulatory requirements i.e.

45、good clinical practice gcp and international conference on harmonisation ich guidelines- in depth therapeutic and protocol knowledge- strong communication and interpersonal skills including good command of english language- strong organizational and problem solving skills- demonstrated ability to deliver results to the appropriate quality and timeline metrics-