優(yōu)質(zhì)文檔臨床監(jiān)察員專業(yè)術(shù)語(yǔ)和職位英文描述

1、縮略語(yǔ)英文全稱中文全稱ADE Adverse Drug Event藥物不良事件ADR Adverse Drug Reaction藥物不良反應(yīng)AE Adverse Event不良事件AlAssists nt Inv estigatorBMIBody Mass IndexClCo-i nv estigatorCOI Coordinating InvestigatorCRA Clinical Research Associate助理研究者體質(zhì)指數(shù)合作研究者協(xié)調(diào)研究者臨床監(jiān)查員（臨床監(jiān)察員）CRCCRFCROClinical Research Coordinator臨床研究協(xié)調(diào)者Case Report

2、 Form病歷報(bào)告表Contract Research Organization 合同研究組織CSA Clinical Study Application CTA Clinical Trial Application臨床研究申請(qǐng)臨床試驗(yàn)免責(zé) 臨床試驗(yàn)方案 臨床試驗(yàn)報(bào)告臨床試驗(yàn)屮請(qǐng)CTX Clinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial ReportDSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會(huì)EDC Electronic Data Capture電子數(shù)據(jù)采集系

3、統(tǒng)EDP Electronic Data Processing 電子數(shù)據(jù)處理系統(tǒng)FDA Food and Drug Administration 美國(guó)食品與藥品管理局 FR Final Report總結(jié)報(bào)告GCP Good Clinical Practice藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GLP Good Laboratory Practice藥物非臨床試驗(yàn)質(zhì)雖管理規(guī)范GMP Good Manufacturing Practice藥品生產(chǎn)質(zhì)暈管理規(guī)范IB Investigator's Brochure研究者手冊(cè)IC Informed Consent知情同意ICF Informed Consen

4、t Form知情同意書(shū)ICH International Conference on Harmonization 國(guó)際協(xié)調(diào)會(huì)議IDM Independent Data Monitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring Committee 獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì) IEC Independent Ethics Committee獨(dú)立倫理委員會(huì)IND Investigational New Drug新藥臨床研究IRB Institutional Review Board機(jī)構(gòu)審査委員會(huì)IVD In Vitro Diagnostic體外診斷IVRS Inter

5、active Voice Response System 互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MA Marketing Approval/Authorization 上市許可證 MCA Medicines Control Agency MHW Ministry of Health and Applicatio n新藥申請(qǐng)NEC NIH PI PL PMA PSI QA QC RA SA SAE SAP SAR SD SD SFDA SDV SEL SI SI英國(guó)藥品監(jiān)督局Welfare Fl 本衛(wèi)生福利部 NDA New DrugNew Drug EntityNational Institutes of Heal

6、thPrincipal Investigator Product License新化學(xué)實(shí)體國(guó)家衛(wèi)生研究所（美國(guó)） 主要研究者 產(chǎn)品許可證Pre-market Approval (Application)上市前許可(申請(qǐng)) Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì) Quality Assura nee Quality Control Regulatory Authorities Site Assessme nt Serious Adverse Eve nt Statistical Analysis Plan Serious Ad

7、verse Reaction Source Data/Document Subject Diary質(zhì)量保證庾量控制監(jiān)督管理部門現(xiàn)場(chǎng)評(píng)估嚴(yán)瑕不良事件統(tǒng)計(jì)分析計(jì)劃藥物臨床試驗(yàn)網(wǎng)受試者招募 嚴(yán)求不良反應(yīng)原始數(shù)據(jù)/文件受試者H記State Food and Drug Administration國(guó)家食品藥品監(jiān)督管理局Source Data Verification Subject Enrollment Log Sub-i nvestigator Spon sor-lnvestigator原始數(shù)據(jù)核準(zhǔn)受試者入選表助理研究者申辦研究者SICSubject Identification Code受試者識(shí)別代

8、碼SOPStandard Operating Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject Screening Log受試者篩選表T&RTest and Referenee Product受試和參比試劑UAEUnexpected Adverse Eve nt預(yù)料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO 國(guó)際藥品管理 當(dāng)局會(huì)議Active Co

9、ntrolAuditAudit ReportAuditorBlank ControlBlin ding/maski ngCase HistoryClinical studyClinical TrialClinical Trial Report陽(yáng)性對(duì)照、活性對(duì)照 稽査稽查報(bào)告稽杳員空白對(duì)照盲法/設(shè)盲病歷臨床研究臨床試驗(yàn)臨床試驗(yàn)報(bào)告依從性協(xié)調(diào)委員會(huì) 交叉研究雙盲Essential Documentation必需文件Exclusion CriteriaInclusion Criteria Information Gathering Initial MeetingInspectionInstituti

10、on InspectionInvestigational Product InvestigatorMonitorMon itoringMonitoring PlanMonitoring Report排除標(biāo)準(zhǔn)入選標(biāo)準(zhǔn)信息收集啟動(dòng)會(huì)議檢察/視察 copyright 機(jī)構(gòu)檢察試驗(yàn)藥物研究者監(jiān)查員（監(jiān)察員）監(jiān)査（監(jiān)察）監(jiān)査計(jì)劃（監(jiān)察計(jì)劃）監(jiān)査報(bào)告（監(jiān)察報(bào)告）Multi-center TrialNon-clinical Study Original Medical Record Outcome Assessme nt Patient FilePatient HistoryPlaceboPlacebo C

11、ontrolPreclinical Study ProtocolProtocol Amendments Randomization Reference Product Sample SizeSerious nessSeveritySingle BlindingSponsorStudy AuditSubject多中心試驗(yàn) 非臨床研究原始醫(yī)療記錄結(jié)果評(píng)價(jià)病人檔案病歷安慰劑創(chuàng)始人袁旭安慰劑對(duì)照臨床前研究試驗(yàn)方案修正案隨機(jī)參比制劑樣本量、樣本大小嚴(yán)更性嚴(yán)重程度單盲申辦者研究稽査受試者Subject Enrollment受試者入選Subject Enrollment Log受試者入選表Subject I

12、dentification Code List受試者識(shí)別代碼表Compliance Coordinating Committee Cross-over Study Double BlindingEndpoint Critena/measurement終點(diǎn)指標(biāo)Subject Recruitment受試者招募Study SiteSubject Screening Log System AuditTest ProductTrial Initial MeetingTrial Master FileTrial ObjectiveTriple Blinding Wash-outWash-out Perio

13、d研究中心受試者篩選表系統(tǒng)稽査 受試制劑試驗(yàn)啟動(dòng)會(huì)議試驗(yàn)總檔案試驗(yàn)?zāi)康娜は疵撓疵撈趇ntroductionQuin tiles Transnational Corp helps improve healthcare worldwide by providi ng a broad range of professional services, information and partnering solutions to the pharmaceutical, biotech no logy and healthcare in dustries Quin tiles helps its cus

14、tomers 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 man age product portfolios more efficie ntly; and achieve strategic and fin ancial objectives by offering tailored alter nat

15、ives to traditi onal fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Caroli na, Quin tiles was fo un ded in 1982 and has more than 16,000 employees and offices in over 50 coun tries Quin tiles Medical Development (Shanghai) Co.

16、, Ltd. is a wholly owned subsidiary of Quintiles Transnational Corp. Further information, please visit our global websiteJob title:Clinical Project Manager(臨床項(xiàng)目經(jīng)理)RESPONSIBILITIESMan age and co-ordi nate efforts of cross-f unctional project teams to support milest one achievement and to man age stud

17、y issues and obstacles and wn sure consistent use of study tools and training materials and compliance with standard processes, policies and procedures Develop study management plans, together with team assgnments and accountabilities and oversight of database maintenance.Serve as primary project co

18、ntact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.Collect informatio n on team performance agai nst con tract, customer expectati ons, and project baselines.Lead problem solvi ng and resolution efforts to in elude manageme nt of risk, continge ncies and

19、issues.Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate partiesProvide input for the development of proposals for new work and manage project budgets Provide in put to line man agers of their project team mem

20、bers* performs nee 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 guidanee and supervision.Ensure high performanee and efficiency of the clinical team through the scheduling o

21、f co monltorl ng/accompa nled slte/vlslts and on going men tori ng of CRA team.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESIn depth knowledge of, and skill in applying, applicable clinical research regulatory requirements;i. e., Good Clin ical Practice (GCP) and Intern ational Conference on Harm on isat

22、i on (ICH) guideli nes Good therapeutic and protocol knowledgeStrong comm un icati on and in terpers onal skills, includi ng good comma nd of En glish Ian guage Good problem solving skillsDemonstrated ability to deliver results to the appropriate quality and timeline metricsGood teamwork skillsExcel

23、lent customer service 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 EXPERIENCEBachelor's degree i

24、n life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experienee in clinical operations; or equivalent combi nation of educatio n, training and experie nee.Job title:Clinical Trials AssistantLocatio n:Beiji ngResponsib

25、ilitiesAssist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site complianee and performarice within project timelinesAssist the clinical team in the preparation, handling, distribution, filing, and archiving of c

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

27、 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, correspondence and associated documentati on.May perform assigned administrative tasks to support team members with clin

28、ical trial execution.All resp on sibilities are esse ntial job fun ctions tin less noted as non esse ntial (N).Required knowledge, skills and abilitiesAwareness of knowledge of applicable clinical research regulatory requirements; i.e.f Good Clinical Practice (GCP) and International Conference on Ha

29、rmonisation (ICH) guidelinesKnowledge of applicable protocol requirements as provided in company trainingComputer skills including proficiency in use of Microsoft Word, Excel and PowerPointStrong writte n and verbal communicati on skills including good comma nd of English languageEffective time mana

30、gement and organizational skillsAnention to detail and accuracy in workAbility to establish and maintai n effective working relati on ships with coworkers, managers and clients Minimum required education and experieneeSchool diploma/certificate or educational equivalent; or equivale nt combi nation

31、of educati on, training and experienceJob title:Clinical research AssistantDescripti onQuin tiles pion eered the idea of helping pharma compa nies 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 desig

32、n and con duct rigorous clin ical 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 f

33、or 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 Clinical Practice (GCP) and the applicable Regulatory requirements-Administer protocol and related

34、study training to assigned site. Establish regular lines of communicati on with sites to man age ongoing project expectations and issues.Qualificatio nsRequirements: Degree in Scienee, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution Minimum 1 ye

35、ar of clinical monitoring experienee in the pharmaceutical / 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 monito

36、ring 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:Senior Clinical Project ManagerDescriptionQuin tiles pion eered the idea of helpi ng pharma compa ni

37、es 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 small studies to multinational mega-trials. However, we continue to develop new ways

38、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-Man age and co-ordinate efforts of cross-functi onal project teams to support milest one achievement and to man age study

39、issues and obstacles En sure consistent use of study tools and traini ng materials and complianee with standard processes, policies and procedures Implement continuous improvement activities for assigned projectsDcvctop study management plans, together with team asoignmcnts and accountabilities and

40、oversight of database maintenance. Serve as primary project con tact with Sponsor to en sure communication is maintained and conti nu ously improved and reporting schedules are adhered to.-Report on team performa nee agai nst con tract, customer expectatio ns, and project baseli nes to man agement.-

41、Lead problem solvi ng and resolution efforts to in elude man agerre nt of risk, contingen cies and issues. Develop proactive con tinge ncy plans to mitigate clinical risk. Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow info

42、rmatio n and quality assura nee audit fin dings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties Collaborate with other functional groups within the company where necessary to support milestone achieveme nt and to man age study issues and ob

43、stacles Provide input for the development of proposals for new work and project budgets Provide in put to line man agers of their project team members performance relative to project tasks. Recommend team members further professional development. Support staff development Mentor less experienced CPM

44、s.-Ensure high performanee and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. Prepare and prese nt project information at in ter nal and exter nal neeti ngs. Participate in proposal development. May lead bid defense

45、presentations in partnership with Business Development and Senior Clinical Project Management staff.-Define project workloads and assignments. Develop and oversee maintenance of intemal databases and project plansQualificatio ns Bachelors degree in life sciences or related field and 7 years clinical

46、 research experienee including 4 years project man agement experie nee and experie nee in clinical operations; or equivale nt combinatio n of education, training and experience-In depth knowledge of, and skill in applying, applicable clinical research regulatory requlrements; l.e., Good Clinical Pra

47、ctice (GCP) and International Conferenee on Harmonisation (ICH) guidelines In depth therapeutic and protocol kno wledge Strong communication and interpersonal skills, including good command of English Ianguage Strong organizational and problem solving skills Demonstrated ability to deliver results t

48、o the appropriate quality and timeline metrics Good team leadership skills-Effective mentoring and training skills-Excellent customer service skills Effective presentation skills Ability to man age competi ng priorities Strong software and computer skills, including MS Office applications Ability to

49、 establish and maintain effective working relati on ships with coworkers, man agers and clients.Job title:Manager, Clinical Operations (China-Beijing)Descripti onQuintiles pioneered the idea of helpi ng pharma compa nies con duct objective clinical trials to establish not only whether a drug is effe

50、ctive, but who can take it safely. Our customers have relied on us to design and con duct 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 trial

51、s and determine outcomes faster.If that is your passion, we have a place for youJob Responsibilities: Resp on sible to lead and man age the project team on regional or global studies Responsible for designing and overseeing the implementation of project specific procedures to ensure that the study g

52、oals are met Participate in clinical operations quality or process initiativesQualificatio ns Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognized tertiary institution-At least 7 years of experienee working on clinical trials with 3 years experienee in

53、 a leadership capacity. Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Strong leadership skills-Excellent organizational and problem solving skills Effective time man ageme nt skills and ability to man age competi ng priorities Strong wrinen and verbal communica

54、tion skills Able to travel when required臨床實(shí)驗(yàn)助理Job Responsibilities:1> Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintainingclinical systems that track site complianee and performance within project timeli nes.2、Assist the clinical team in

55、 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 completeness3、Assist CTLs with preparation, handling and distribution of

56、 Clinical Trial Supplies and maintenance of tracking information.Assist 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 documentation5、Provide administrative support to team members with clinical trial execution.Requirements:1、Awa