临床监察员专业术语和职位英文描述.docx

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AEAdverse Event不良事件AI Assistant Investigator助理研究者BMI Body Mass Index体质指数 药物临床试验网百科 CI Co-investigator 合作研究者COI Coordinating Investigator 协调研究者CRAClinical 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 病历报告表CRO Contract Research Organization 合同研究组织CSAClinical Study Application 临床研究申请CTAClinical Trial Application 临床试验申请 药物临床试验网国内最大最活跃的临床试验平台 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DSMBData Safety and monitoring Board数据安全及监控委员会EDC 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FR Final Report 总结报告 GCP Good Clinical Practice 药物临床试验质量管理规范GLP Good Laboratory Practice 药物非临床试验质量管理规范GMPGood Manufacturing Practice 药品生产质量管理规范IB Investigators Brochure 研究者手册IC Informed 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 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）PI Principal Investigator 主要研究者PL Product 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 QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis 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 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration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 Sub-investigator 助理研究者 SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 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 AuthoritiesWHO国际药品管理当局会议 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Compliance 依从性Coordinating Committee 协调委员会Cross-over Study 交叉研究 Double Blinding 双盲Endpoint Criteria/measurement 终点指标Essential Documentation 必需文件Exclusion Criteria 排除标准Inclusion Criteria 入选标准Information Gathering 信息收集Initial Meeting 启动会议Inspection 检察/视察 copyright Institution Inspection 机构检察Investigational Product 试验药物Investigator 研究者Monitor 监查员（监察员）Monitoring 监查（监察）Monitoring Plan 监查计划（监察计划）Monitoring Report 监查报告（监察报告） Multi-center Trial 多中心试验Non-clinical Study 非临床研究Original Medical Record 原始医疗记录Outcome Assessment 结果评价Patient File 病人档案Patient History 病历Placebo 安慰剂 创始人袁旭Placebo Control 安慰剂对照Preclinical Study 临床前研究Protocol 试验方案Protocol Amendments 修正案Randomization 随机Reference Product 参比制剂Sample Size 样本量、样本大小 Seriousness 严重性Severity 严重程度Single Blinding 单盲Sponsor 申办者Study Audit 研究稽查Subject 受试者 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 Recruitment 受试者招募Study Site 研究中心Subject Screening Log 受试者筛选表System Audit 系统稽查Test Product 受试制剂 Trial Initial Meeting 试验启动会议Trial Master File 试验总档案Trial Objective 试验目的Triple Blinding 三盲Wash-out 洗脱Wash-out Period 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 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 sales, 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 Carolina, 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 Manager(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.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 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 and 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 members 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 of 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) guidelinesGood therapeutic and protocol knowledgeStrong communication and interpersonal skills, including good command of English languageGood problem solving 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 working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelors 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 equivalent 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 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 with 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, correspondence 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 clinical 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 PowerPointStrong 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 education and experienceSchool diploma/certificate or educational equivalent; or equivalent combination of education, training and experienceJob title:Clinical research 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 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.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 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 Pharmacy, 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 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:Senior 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 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 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 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 project 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 management 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 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 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 through 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 Clinical 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 and 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) guidelines- 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 skills- 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 coworkers, 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 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 more effective trials and determine outcomes faster.If that is your passion, we have a place 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 qualit