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    Adverse Drug Event               &#

2、160; 药物不良事件ADR  Adverse Drug Reaction              药物不良反应AE     Adverse Event                    

3、60; 不良事件AI  Assistant Investigator             助理研究者BMI  Body Mass Index                     体质指数CI  

4、0;   Co-investigator                         合作研究者COI     Coordinating Investigator         协调研究者CRA Clin

5、ical Research Associate         临床监查员（临床监察员）CRC     Clinical Research Coordinator         临床研究协调者CRF     Case Report Form          

6、;       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   &

7、#160;     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

8、     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EDC     Electronic Data Capture       

9、          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FR    

10、0; Final Report                         总结报告GCP Good Clinical Practice                 药物临床试验质量

11、管理规范GLP     Good Laboratory Practice         药物非临床试验质量管理规范GMP Good Manufacturing Practice         药品生产质量管理规范IB      Investigators Brochure     &#

12、160;   研究者手册IC      Informed Consent                 知情同意ICF     Informed Consent Form             &

13、#160;   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 &#

14、160;   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

15、构审查委员会IVD     In Vitro Diagnostic                 体外诊断IVRS    Interactive Voice Response System 互动语音应答系统MA      Marketing Approval/Authorization 上市许可证

16、MCA     Medicines Control Agency         英国药品监督局MHW     Ministry of Health and Welfare         日本卫生福利部 NDA     New Drug Application     

17、;            新药申请NEC     New Drug Entity                         新化学实体NIH     Nationa

18、l Institutes of Health         国家卫生研究所（美国）PI      Principal Investigator                 主要研究者PL      Product License  &

19、#160;                      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

20、会QA      Quality Assurance                 质量保证QC      Quality Control                

21、0;        质量控制RA      Regulatory Authorities                  监督管理部门SA      Site Assessment       &#

22、160;                 现场评估SAE     Serious Adverse Event                 严重不良事件SAP     Statistical Ana

23、lysis Plan         统计分析计划药物临床试验网受试者招募SAR     Serious Adverse Reaction         严重不良反应SD      Source Data/Document          

24、60;      原始数据/文件SD      Subject Diary                         受试者日记SFDA    State Food and Drug Administration 

25、国家食品药品监督管理局SDV     Source Data Verification         原始数据核准SEL     Subject Enrollment Log                 受试者入选表SI    

26、60; Sub-investigator                  助理研究者SI      Sponsor-Investigator                 申办研究者SIC   &

27、#160; Subject Identification Code         受试者识别代码SOP     Standard Operating Procedure         标准操作规程SPL     Study Personnel List        

28、0;        研究人员名单SSL     Subject Screening Log                 受试者筛选表T&R     Test and Reference Product      

29、60;  受试和参比试剂UAE     Unexpected Adverse Event         预料外不良事件WHO     World Health Organization         世界卫生组织WHO-ICDRA  WHO International Conference of Drug Regulatory Aut

30、horities WHO国际药品管理当局会议 Active Control                         阳性对照、活性对照 Audit               

31、60;             稽查 Audit Report                     稽查报告 Auditor            

32、0;                稽查员 Blank Control                      空白对照 Blinding/masking       

33、              盲法/设盲 Case History                     病历 Clinical study           

34、;          临床研究 Clinical Trial                     临床试验 Clinical Trial Report             临床试验报

35、告 Compliance                             依从性 Coordinating Committee             协调委员会 Cross-ove

36、r Study                     交叉研究 Double Blinding                     双盲 Endpoint Criteria/measuremen

37、t     终点指标 Essential Documentation             必需文件 Exclusion Criteria                     排除标准 Inclusion Criteria&

38、#160;                    入选标准 Information Gathering              信息收集 Initial Meeting          

39、           启动会议 Inspection                              检察/视察 copyright  Institution Inspection 

40、;            机构检察 Investigational Product             试验药物 Investigator                    

41、; 研究者 Monitor                              监查员（监察员） Monitoring               

42、60;              监查（监察） Monitoring Plan                     监查计划（监察计划） Monitoring Report        

43、;             监查报告（监察报告） Multi-center Trial                     多中心试验 Non-clinical Study        

44、0;            非临床研究 Original Medical Record             原始医疗记录 Outcome Assessment                 &#

45、160;   结果评价 Patient File                     病人档案 Patient History                     

46、; 病历 Placebo                             安慰剂创始人袁旭 Placebo Control                

47、;     安慰剂对照 Preclinical Study                     临床前研究 Protocol                   &#

48、160;          试验方案 Protocol Amendments                     修正案 Randomization             &

49、#160;        随机 Reference Product                     参比制剂 Sample Size                

50、;      样本量、样本大小 Seriousness                      严重性 Severity                  &

51、#160;           严重程度 Single Blinding                      单盲 Sponsor             

52、;                申办者 Study Audit                             研究稽查 Subject &

53、#160;                           受试者 Subject Enrollment                    

54、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 Recruitment              受试者招募 Study Site&#

55、160;                            研究中心 Subject Screening Log             受试者筛选表 System Audit  

56、60;                  系统稽查 Test Product                     受试制剂 Trial Initial Meeting      

57、;        试验启动会议 Trial Master File                     试验总档案 Trial Objective               

58、       试验目的 Triple Blinding                     三盲 Wash-out                  

59、60;           洗脱 Wash-out Period                     洗脱期introductionQuintiles Transnational Corp. helps improve healthcare worldwide by providing a br

60、oad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. 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 sale

61、s, build effective sales forces and manage product portfolios more efficiently; and achieve strategic and financial objectives by offering tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Car

62、olina, Quintiles was founded in 1982 and has more than 16,000 employees and offices in over 50 countries. Quintiles Medical Development (Shanghai) Co., Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Further information, please visit our global website Job title:Clinical Project M

63、anager(临床项目经理)RESPONSIBILITIESManage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.Dev

64、elop study management plans, together with team assignments and accountabilities and oversight of database maintenance.Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect information on team performance against contract,

65、customer expectations, and project baselines.Lead problem solving and resolution efforts to include management of risk, contingencies and issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.Provid

66、e input for the development of proposals for new work and manage project budgets.Provide input to line managers of their project team members' performance relative to project tasks.Prepare and present project information at internal and external meetings.Participate in proposal development and i

67、n the bid-defense process with guidance and supervision.Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESIn depth knowledge of, and skill in applying,

68、applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelinesGood therapeutic and protocol knowledgeStrong communication and interpersonal skills, including good command of English languageGood problem solving

69、skillsDemonstrated ability to deliver results to the appropriate quality and timeline metricsGood teamwork skillsExcellent customer service skillsGood presentation skillsGood judgmentStrong software and computer skills, including MS Office applicationsAbility to establish and maintain effective work

70、ing relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivale

71、nt combination of education, training and experience. Job title:Clinical Trials AssistantLocation:BeijingResponsibilitiesAssist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within

72、 project timelines.Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.Assist CTLs w

73、ith preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking 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 project communications, corr

74、espondence and associated 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 knowledge of applicable clini

75、cal research regulatory requirements; i.e., Good Clinical Practice (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 PowerPointStro

76、ng 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 required educa

77、tion and experienceSchool diploma/certificate or educational equivalent; or equivalent combination of education, training and experienceJob title:Clinicalresearch AssistantDescriptionQuintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whet

78、her 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 create mor

79、e 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 in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinica

80、l Practice (GCP) and the 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 Pharma

81、cy, Biological / Life Sciences or Nursing from a recognized tertiary institution- Minimum 1 year of clinical monitoring experience in the pharmaceutical / CRO industry.- For Senior Research Associate position, minimum 3 years clinical monitoring experience, preferably with some experience in leading

82、 clinical teams in the region- Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and GCP/ICH guidelines- Excellent organizational and problem solving skills- Strong written and verbal communication skills- Ability to travel when requiredJob title:S

83、enior Clinical Project ManagerDescriptionQuintiles 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 deca

84、des, 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 for you.Responsibilities- Manage and co-ordinate eff

85、orts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned proj

86、ects.- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.- Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to.- Report on team per

87、formance against contract, customer expectations, and project baselines to management.- 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 throug

88、h regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.- Collaborate with other functional groups within the company wher

89、e necessary to support milestone achievement and 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

90、 professional development. Support staff development. Mentor less experienced CPMs.- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team.- Prepare and present project information at internal and

91、 external meetings.- Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff.- Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plansQualif

92、ications- Bachelors degree in life sciences or related field and 7 years clinical research experience including 4 years project management experience and experience in clinical operations; or equivalent combination of education, training and experience.- In depth knowledge of, and skill in applying,

93、 applicable clinical research regulatory requirements; i.e., 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- De