临床监察员专业术语和职位英文描述.docx
《临床监察员专业术语和职位英文描述.docx》由会员分享，可在线阅读，更多相关《临床监察员专业术语和职位英文描述.docx（19页珍藏版）》请在冰豆网上搜索。
临床监察员专业术语和职位英文描述
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
AE AdverseEvent 不良事件
AI AssistantInvestigator 助理研究者
BMI BodyMassIndex 体质指数
CI Co-investigator 合作研究者
COI CoordinatingInvestigator 协调研究者
CRA ClinicalResearchAssociate 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 ContractResearchOrganization 合同研究组织
CSA ClinicalStudyApplication 临床研究申请
CTA ClinicalTrialApplication 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
DSMB DataSafetyandmonitoringBoard 数据安全及监控委员会
EDC ElectronicDataCapture 电子数据采集系统
EDP ElectronicDataProcessing 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
GMP GoodManufacturingPractice 药品生产质量管理规范
IB Investigator’sBrochure 研究者手册
IC InformedConsent 知情同意
ICF InformedConsentForm 知情同意书
ICH InternationalConferenceonHarmonization 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/Authorization 上市许可证
MCA MedicinesControlAgency 英国药品监督局
MHW MinistryofHealthandWelfare 日本卫生福利部NDA NewDrugApplication 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 Pre-marketApproval（Application） 上市前许可（申请）
PSI StatisticiansinthePharmaceuticalIndustry 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
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 Sub-investigator 助理研究者
SI Sponsor-Investigator 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
T&R 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
WHO-ICDRA WHOInternationalConferenceofDrugRegulatoryAuthorities WHO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 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
Cross-overStudy 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
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）
Multi-centerTrial 多中心试验
Non-clinicalStudy 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 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
SubjectIdentificationCodeList 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
Wash-out 洗脱
Wash-outPeriod 洗脱期
introduction
QuintilesTransnationalCorp.helpsimprovehealthcareworldwidebyprovidingabroadrangeofprofessionalservices,informationandpartneringsolutionstothepharmaceutical,biotechnologyandhealthcareindustries.Quintileshelpsitscustomerscompressthetimeittakestobringadrugfromdiscoverythroughregulatoryapproval;acceleratethelaunchofproductstopeaksales,buildeffectivesalesforcesandmanageproductportfoliosmoreefficiently;andachievestrategicandfinancialobjectivesbyofferingtailoredalternativestotraditionalfee-for-serviceproductdevelopmentandcommercialservicesagreements.HeadquarterednearResearchTrianglePark,NorthCarolina,Quintileswasfoundedin1982andhasmorethan16,000employeesandofficesinover50countries.QuintilesMedicalDevelopment（Shanghai）Co.,Ltd.isawhollyownedsubsidiaryofQuintilesTransnationalCorp.Furtherinformation,pleasevisitourglobalwebsite
Jobtitle:
ClinicalProjectManager（临床项目经理）
RESPONSIBILITIES
Manageandco-ordinateeffortsofcross-functionalprojectteamstosupportmilestoneachievementandtomanagestudyissuesandobstaclesandensureconsistentuseofstudytoolsandtrainingmaterialsandcompliancewithstandardprocesses,policiesandprocedures.
Developstudymanagementplans,togetherwithteamassignmentsandaccountabilitiesandoversightofdatabasemaintenance.
ServeasprimaryprojectcontactwithSponsortoensurecommunicationismaintainedandreportingschedulesareadheredto.
Collectinformationonteamperformanceagainstcontract,customerexpectations,andprojectbaselines.
Leadproblemsolvingandresolutioneffortstoincludemanagementofrisk,contingenciesandissues.
Identifyqualityissueswithinthestudytoimplementappropriatecorrectiveactionplans.Escalatefindingsandactionplanstoappropriateparties.
Provideinputforthedevelopmentofproposalsfornewworkandmanageprojectbudgets.
Provideinputtolinemanagersoftheirprojectteammembers'performancerelativetoprojecttasks.
Prepareandpresentprojectinformationatinternalandexternalmeetings.
Participateinproposaldevelopmentandinthebid-defenseprocesswithguidanceandsupervision.
Ensurehighperformanceandefficiencyoftheclinicalteamthroughtheschedulingofco-monitoring/accompaniedsite/visitsandongoingmentoringofCRAteam.
REQUIREDKNOWLEDGE,SKILLSANDABILITIES
Indepthknowledgeof,andskillinapplying,applicableclinicalresearchregulatoryrequirements;i.e.,GoodClinicalPractice（GCP）andInternationalConferenceonHarmonisation（ICH）guidelines
Goodtherapeuticandprotocolknowledge
Strongcommunicationandinterpersonalskills,includinggoodcommandofEnglishlanguage
Goodproblemsolvingskills
Demonstratedabilitytodeliverresultstotheappropriatequalityandtimelinemetrics
Goodteamworkskills
Excellentcustomerserviceskills
GoodpresentationskillsGoodjudgment
Strongsoftwareandcomputerskills,includingMSOfficeapplications
Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients
MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
Bachelor'sdegreeinlifesciencesorrelatedfieldand5years'clinicalresearchexperienceincluding2years'projectmanagementexperienceandexperienceinclinicaloperations;orequivalentcombinationofeducation,trainingandexperience.
Jobtitle:
ClinicalTrialsAssistant
Location:
Beijing
Responsibilities
AssistClinicalTeamLead（CTL）andClinicalResearchAssociat
升级会员 