臨床監(jiān)察員專業(yè)術(shù)語和職位英文描述

1、縮略語 英文全稱                          中文全稱ADE    Adverse Drug Event               &#

2、160; 藥物不良事件ADR  Adverse Drug Reaction              藥物不良反應(yīng)AE     Adverse Event                    

3、60; 不良事件AI  Assistant Investigator             助理研究者BMI  Body Mass Index                     體質(zhì)指數(shù)CI  

4、0;   Co-investigator                         合作研究者COI     Coordinating Investigator         協(xié)調(diào)研究者CRA Clin

5、ical Research Associate         臨床監(jiān)查員（臨床監(jiān)察員）CRC     Clinical Research Coordinator         臨床研究協(xié)調(diào)者CRF     Case Report Form          

6、;       病歷報告表CRO     Contract Research Organization         合同研究組織CSA Clinical Study Application         臨床研究申請CTA Clinical Trial Application   &

7、#160;     臨床試驗申請CTX     Clinical Trial Exemption         臨床試驗免責(zé)CTP     Clinical Trial Protocol                 臨床試驗方案CTR

8、     Clinical Trial Report                 臨床試驗報告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會EDC     Electronic Data Capture       

9、          電子數(shù)據(jù)采集系統(tǒng)EDP  Electronic Data Processing         電子數(shù)據(jù)處理系統(tǒng)FDA     Food and Drug Administration        美國食品與藥品管理局FR    

10、0; Final Report                         總結(jié)報告GCP Good Clinical Practice                 藥物臨床試驗質(zhì)量

11、管理規(guī)范GLP     Good Laboratory Practice         藥物非臨床試驗質(zhì)量管理規(guī)范GMP Good Manufacturing Practice         藥品生產(chǎn)質(zhì)量管理規(guī)范IB      Investigators Brochure     &#

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

13、#160;   知情同意書ICH     International Conference on Harmonization 國際協(xié)調(diào)會議IDM     Independent Data Monitoring         獨立數(shù)據(jù)監(jiān)察IDMC    Independent Data Monitoring Committee 獨立數(shù)據(jù)監(jiān)察委員會IEC &#

14、160;   Independent Ethics Committee         獨立倫理委員會IND   Investigational New Drug         新藥臨床研究IRB     Institutional Review Board         機

15、構(gòu)審查委員會IVD     In Vitro Diagnostic                 體外診斷IVRS    Interactive Voice Response System 互動語音應(yīng)答系統(tǒng)MA      Marketing Approval/Authorization 上市許可證

16、MCA     Medicines Control Agency         英國藥品監(jiān)督局MHW     Ministry of Health and Welfare         日本衛(wèi)生福利部 NDA     New Drug Application     

17、;            新藥申請NEC     New Drug Entity                         新化學(xué)實體NIH     Nationa

18、l Institutes of Health         國家衛(wèi)生研究所（美國）PI      Principal Investigator                 主要研究者PL      Product License  &

19、#160;                      產(chǎn)品許可證PMA     Pre-market Approval (Application) 上市前許可（申請）PSI     Statisticians in the Pharmaceutical Industry  制藥業(yè)統(tǒng)計學(xué)家協(xié)

20、會QA      Quality Assurance                 質(zhì)量保證QC      Quality Control                

21、0;        質(zhì)量控制RA      Regulatory Authorities                  監(jiān)督管理部門SA      Site Assessment       &#

22、160;                 現(xiàn)場評估SAE     Serious Adverse Event                 嚴(yán)重不良事件SAP     Statistical Ana

23、lysis Plan         統(tǒng)計分析計劃藥物臨床試驗網(wǎng)受試者招募SAR     Serious Adverse Reaction         嚴(yán)重不良反應(yīng)SD      Source Data/Document          

24、60;      原始數(shù)據(jù)/文件SD      Subject Diary                         受試者日記SFDA    State Food and Drug Administration 

25、國家食品藥品監(jiān)督管理局SDV     Source Data Verification         原始數(shù)據(jù)核準(zhǔn)SEL     Subject Enrollment Log                 受試者入選表SI    

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

27、#160; Subject Identification Code         受試者識別代碼SOP     Standard Operating Procedure         標(biāo)準(zhǔn)操作規(guī)程SPL     Study Personnel List        

28、0;        研究人員名單SSL     Subject Screening Log                 受試者篩選表T&R     Test and Reference Product      

29、60;  受試和參比試劑UAE     Unexpected Adverse Event         預(yù)料外不良事件WHO     World Health Organization         世界衛(wèi)生組織WHO-ICDRA  WHO International Conference of Drug Regulatory Aut

30、horities WHO國際藥品管理當(dāng)局會議 Active Control                         陽性對照、活性對照 Audit               

31、60;             稽查 Audit Report                     稽查報告 Auditor            

32、0;                稽查員 Blank Control                      空白對照 Blinding/masking       

33、              盲法/設(shè)盲 Case History                     病歷 Clinical study           

34、;          臨床研究 Clinical Trial                     臨床試驗 Clinical Trial Report             臨床試驗報

35、告 Compliance                             依從性 Coordinating Committee             協(xié)調(diào)委員會 Cross-ove

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

37、t     終點指標(biāo) Essential Documentation             必需文件 Exclusion Criteria                     排除標(biāo)準(zhǔn) Inclusion Criteria&

38、#160;                    入選標(biāo)準(zhǔn) Information Gathering              信息收集 Initial Meeting          

39、           啟動會議 Inspection                              檢察/視察 copyright  Institution Inspection 

40、;            機構(gòu)檢察 Investigational Product             試驗藥物 Investigator                    

41、; 研究者 Monitor                              監(jiān)查員（監(jiān)察員） Monitoring               

42、60;              監(jiān)查（監(jiān)察） Monitoring Plan                     監(jiān)查計劃（監(jiān)察計劃） Monitoring Report        

43、;             監(jiān)查報告（監(jiān)察報告） Multi-center Trial                     多中心試驗 Non-clinical Study        

44、0;            非臨床研究 Original Medical Record             原始醫(yī)療記錄 Outcome Assessment                 &#

45、160;   結(jié)果評價 Patient File                     病人檔案 Patient History                     

46、; 病歷 Placebo                             安慰劑創(chuàng)始人袁旭 Placebo Control                

47、;     安慰劑對照 Preclinical Study                     臨床前研究 Protocol                   &#

48、160;          試驗方案 Protocol Amendments                     修正案 Randomization             &

49、#160;        隨機 Reference Product                     參比制劑 Sample Size                

50、;      樣本量、樣本大小 Seriousness                      嚴(yán)重性 Severity                  &

51、#160;           嚴(yán)重程度 Single Blinding                      單盲 Sponsor             

52、;                申辦者 Study Audit                             研究稽查 Subject &

53、#160;                           受試者 Subject Enrollment                    

54、受試者入選 Subject Enrollment Log             受試者入選表 Subject Identification Code List     受試者識別代碼表 Subject Recruitment              受試者招募 Study Site&#

55、160;                            研究中心 Subject Screening Log             受試者篩選表 System Audit  

56、60;                  系統(tǒng)稽查 Test Product                     受試制劑 Trial Initial Meeting      

57、;        試驗啟動會議 Trial Master File                     試驗總檔案 Trial Objective               

58、       試驗?zāi)康?#160;Triple Blinding                     三盲 Wash-out                  

59、60;           洗脫 Wash-out Period                     洗脫期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(臨床項目經(jīng)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