临床监察员专业术语和职位英文描述

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1、缩略语 英文全称中文全称ADE Adverse Drug Event药物不良事件ADR Adverse Drug Reaction药物不良反应AE Adverse EventAI Assistant InvestigatorBMI Body Mass IndexCI Co-investigatorCOI Coordinating Investigato CRA Clinical Research Associate不良事件助理研究者体质指数合作研究者r 协调研究者临床监查员（临床监察员）FR FinalMarketingNew DrugCRC Clinical Research Coordin

2、ator 临床研究协调者CRF Case Report Form病历报告表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application临床研究申请CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption临床试验免责CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会ED

3、C Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统FDA Food and Drug Administration 美 国 食 品 与 药 品 管 理 局 Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规 XGLP Good Laboratory Practice 药物非临床试验质量管理规 XGMP Good Manufacturing Practice 药品生产质量管理规 XIB Investigators Brochure 研究者手册IC Inf

4、ormed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审

5、查委员会IVD In Vitro Diagnostic体外诊断IVRS Interactive Voice Response System 互 动 语 音 应 答 系 统 MA Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日 本 卫 生 福 利 部 NDAApplication 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health国家卫生研究所（美国）PIPrincipa

6、l Investigator主要研究者PLProduct License产品许可证PMA Pre-market Approval （Application） 上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QAQuality AssuranceQCQuality ControlRA Regulatory AuthoritiesSA Site AssessmentSAE Serious Adverse EventSAP Statistical Analysis Plan SAR Serious Adverse

7、Reaction SD Source Data/Document SD Subject Diary质量保证质量控制监督管理部门现场评估 严重不良事件 统计分析计划药物临床试验网受试者招募 严重不良反应 原始数据/文件 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局 SDV Source DataVerification 原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator 助理研究者SISponsor-Investigator申办研究者SICSubject Identif

8、ication Code受试者识别代码SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员SSLSubject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 国际药品管理当局会

9、议Active Control阳性对照、活性对照Audit稽查Audit Report稽查报告Auditor稽查员Blank Control空白对照Blinding/masking盲法/设盲Case History病历Clinical study临床研究Clinical Trial临床试验Clinical Trial Report临床试验报告 ComplianceCoordinating Committee 协调委员会Cross-over Study交叉研究Double Blinding双盲Endpoint Criteria/measurement 终点指标依从性Essential Docum

10、entation必需文件排除标准 入选标准Exclusion CriteriaInclusion CriteriaInformation GatheringInitial MeetingInspectionInstitution InspectionInvestigational ProductInvestigatorMonitorMonitoringMonitoring PlanMonitoring Report信息收集启动会议检察/视察 copyright 机构检察试验药物研究者监查员（监察员） 监查（监察） 监查计划（监察计划） 监查报告（监察报告）Multi-center Trial

11、Non-clinical Study Original Medical Record Outcome Assessment Patient FilePatient HistoryPlaceboPlacebo ControlPreclinical StudyProtocolProtocol Amendments RandomizationReference Product Sample SizeSeriousnessSeveritySingle BlindingSponsorStudy AuditSubject多中心试验非临床研究 原始医疗记录 结果评价 病人档案病历 安慰剂创始人袁旭 安慰剂对

12、照 临床前研究 试验方案 修正案随机 参比制剂 样本量、样本大小 严重性 严重程度iVr单盲申办者研究稽查VS7, -Ay.受试者受试者招募 Study Site受试者筛选表 系统稽查 受试制剂试验启动会议试验总档案研究中心Subject Enrollment受试者入选Subject Enrollment Log受试者入选表Subject Identification Code List 受试者识别代码表Subject RecruitmentSubject Screening LogSystem AuditTest ProductTrial Initial MeetingTrial Maste

13、r FileTrial Objective Triple Blinding Wash-out Wash-out Period试验目的三盲洗脱洗脱期introductionQuintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industri

14、es. Quintiles helps its customers compress the time it takes to bring a drug from discovery through regulatory approval; accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently; andachieve strategic and financial objectives by offe

15、ring tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and has more than 16,000 employees and offices in over 50 countries. Quintiles Medical Developmen

16、t (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Further information, please visit our global websiteJob title:Clinical Project Manager(临床项目经理)RESPONSIBILITIESManage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to

17、manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary

18、 project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect information on team performance against contract, customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies a

19、nd issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provide input for the development of proposals for new work and manage project budgets.Provide input to line managers of their project team m

20、embers performance relative to project tasks.Prepare and present project information at internal and external meetings.Participate in proposal development and in the bid-defense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling o

21、f co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESIn depth knowledge of, and skill in applying, applicable clinical research regulatory requirements;i. e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH)

22、 guidelines Good therapeutic and protocol knowledgeStrong communication and interpersonal skills, including good command of English language Good problem solving skillsDemonstrated ability to deliver results to the appropriate quality and timeline metricsGood teamwork skillsExcellent customer servic

23、e skillsGood presentation skillsGood judgmentStrong software and computer skills, including MS Office applicationsAbility to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelors degree in life sciences or relate

24、d field and 5 years clinical research experience including 2 years project management experience and experience in clinical operations; or equivalent combination of education, training and experience.Job title:Clinical Trials AssistantLocation:BeijingResponsibilitiesAssist Clinical Team Lead (CTL) a

25、nd Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports accord

26、ing to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Assist with the tracking and management of C

27、ase Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.May perform assigned administrative tasks to support team members with clinical trial execution.All responsibiliti

28、es are essential job functions unless noted as nonessential (N).Required knowledge, skills and abilitiesAwareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesKnowledge of applic

29、able protocol requirements as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPointStrong written and verbal communication skills including good command of English languageEffective time management and organizational skillsAttention to detai

30、l and accuracy in workAbility to establish and maintain effective working relationships with coworkers, managers and clients Minimum required education and experienceSchool diploma/certificate or educational equivalent; or equivalent combination of education, training and experienceJob title:Clinica

31、lresearch AssistantDescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from s

32、mall studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.If that is your passion, we have a place for you.Job Responsibilities:- Oversees the progress of a Clini

33、cal Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.- Administer protocol and related study training to assigned site.- Establish regular lines o

34、f communication with sites to manage ongoing project expectations and issues. QualificationsRequirements:- Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution- Minimum 1 year of clinical monitoring experience in the pharmaceutical

35、 / CRO industry.- For Senior Research Associate position, minimum 3 years clinical monitoring experience, preferably with some experience in leading clinical teams in the region- Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and GCP/ICH guideli

36、nes- Excellent organizational and problem solving skills- Strong written and verbal communication skills- Ability to travel when requiredJob title:Senior Clinical Project ManagerDescription Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not on

37、ly whether a drug is effective, but who can take it safely. Our customers have relied on us to design and 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 cre

38、ate more 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 project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools

39、and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects.- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.- Serve as primary pro

40、ject contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.- Report on team performance against contract, customer expectations, and project baselines to management.- Lead problem solving and resolution efforts to include manageme

41、nt 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, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate

42、corrective action plans. Escalate findings and action plans to appropriate parties.- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.- Provide input for the development of proposals for new work and

43、 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 development. Mentor less experienced CPMs.- Ensure high performance and efficiency of the clinical team throug

44、h the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.- Prepare and present project information at internal and external meetings.- Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinic

45、al Project Management staff.- Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plansQualifications- Bachelors degree in life sciences or related field and 7 years clinical research experience including 4 years project management experience a

46、nd experience in clinical operations; or equivalent combination of education, training and experience.- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guideline

47、s- 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- Good team leadership s

48、kills- Effective mentoring and training skills- Excellent customer service skills- Effective presentation skills- Ability to manage competing priorities- Strong software and computer skills, including MS Office applications- Ability to establish and maintain effective working relationships with cowo

49、rkers, managers and clients.Job title:Manager, Clinical Operations (China- Beijing)DescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to d

50、esign and 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 create more effective trials and determine outcomes faster.If that is your passion, we have a place

51、 for you.Job Responsibilities:- Responsible to lead and manage the project team on regional or global studies- Responsible for designing and overseeing the implementation of project specific procedures to ensure that the study goals are met- Participate in clinical operations quality or process init

52、iatives.Qualifications- Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution- At least 7 years of experience working on clinical trials with 3 years experience in a leadership capacity.- Advanced knowledge and ability to apply GCP/

53、ICH and applicable regulatory guidelines- Strong leadership skills- Excellent organizational and problem solving skills- Effective time management skills and ability to manage competing priorities- Strong written and verbal communication skills- Able to travel when required临床实验助理Job Responsibilities

54、: 1、Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site compliance and performance within project timelines.2、Assist the clinical team in the preparation, handling, distribution, filing, and archiving of cli

55、nical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.3 、 Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.As

56、sist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.4、Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.5、Provide administrative support to team members with clinical trial e

57、xecution. Requirements:1、Awareness of knowledge of applicable clinical research regulatory requirements; i.e.,Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.2、Knowledge of applicable protocol requirements as provided in company training.Computer skills in

58、cluding proficiency in use of Microsoft Word, Excel and PowerPoint.3、Strong written and verbal communication skills including good command of English language4、Attention to detail and accuracy in work.5、Diploma or bachelor degree;or equivalent combination of education, training and experience主坏UKU公可

59、力处lU井盖于庚吉一、世界分布特点合同研究组织(CRO, Contract Research Organization)也称 临床研究组织(Clinical Research Organization ) , 2 008 年全球 CRO市场规模为1烫亿美元( 1 278亿元)，预计，2010年市场规摸将 突破24。亿美元(1032亿元)，。据测算，在全1100多家CRO公司 中，前40家大型公司占据了全球市场份额的80A9臥I从全球范围来看，CRO公司主要积聚在美国东海岸”、“欧洲 西部、“亚洲东部”等3条聚集带上。附| 1; Cuvance公兀全球机倚分仙圈附茨1：北京田际X CRO公司汇总

60、茨序号公司名特全国分布北京分布1Qu inti les北京、上海两处东城区王府井大街2CoVahcc北京、上海两处东城区环球贸易中心3Pharmaceutica1 ProductDevelopment(PPD)北京、上海两处K东城区崇文门大 街：2、西城区裕民路：3、昌平区生命园4Charles River Laboratories(GfiL)仅在上海无5Parexe1北京.上海.广州、成都四处朝阳区朝阳门外大街6ICON仅在天津秦达医院无7Kendle北京.上海两处东熾区环球贸易中心8Pharmanet仅在北京朝阳区朝外大街9PRA Internat ional仅在上海无10Aptuit仅在

61、北京物流配送仓库（具休 地址不详）11Aver ion无无12Bi o Imag i ng无无13Ch i 1torn无无14CMIC仅在北京东城区崇文门大街15Eminent Research Systems,1 nc.无无16Ga 1 apago5 (B i ofocu5)无无17GVK Bi osciences于.无18i3无无19Ingen i x仅在上海无20INC Research北京、上海两处朝阳区CBD21LAB Research无无22L i fe Scienices Research无无23McdPacc仅在北京胡阳区高碑店24MRA无无25NDA Regulatory S

62、cicniGe无无26Novel la Clinical无无27Omni care北京.上海两处朝阳区建国门外28Paragon Biomedical, Inc.无无29PharnrOlam Internatioral无无30PSI无无31Quant icat&无无32Radiant Research无无33Rho无无能5无无5SNBL无无Stat-TInc无无Syrexjs无无Target卜 1 hq.无tfcatat仅程北京在城区讎国门内尢衛40VuXii Pharmtech Co药明康 徳新药井岌韦眼司！无咏天津 上海、苏押刃处无CRASkills Strong computer and internet skills including knowledge of MS-Office products such as Excel,Word Strong regulatory knowledge including GCP Excellent interpersonal, verbal and written communication skills Sound problem solving skills Ability to successfully work in a (virtual) team env