临床监察员专业术语和职位英文描述
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 Event 不良事件
AI Assistant Investigator 助理研究者
BMI Body Mass Index 体质指数
CI Co-investigator 合作研究者
COI Coordinating Investigator 协调研究者
CRA Clinical 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
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
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
GMP Good Manufacturing Practice 药品生产质量管理规范
IB Investigator’s 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 Authorities WHO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
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 https://www.wendangku.net/doc/5b2571565.html, 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
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
introduction
Quintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solution s 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)
RESPONSIBILITIES
Manage 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 ABILITIES
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 Good therapeutic and protocol knowledge
Strong communication and interpersonal skills, including good command of English language Good problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good teamwork skills
Excellent customer service skills
Good presentation skillsGood judgment
Strong software and computer skills, including MS Office applications
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor'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 equivalent combination of education, training and experience.
Job title:Clinical Trials Assistant
Location:Beijing
Responsibilities
Assist 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 abilities
Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Knowledge of applicable protocol requirements as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
Strong written and verbal communication skills including good command of English language
Effective time management and organizational skills
Attention to detail and accuracy in work
Ability to establish and maintain effective working relationships with coworkers, managers and clients Minimum required education and experience
School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience
Job title:Clinical research Assistant
Description
Quintiles 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.
Qualifications
Requirements:
- 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 required
Job title:Senior Clinical Project Manager
Description
Quintiles 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 plans
Qualifications
- 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)
Description
Quintiles 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 quality or process initiatives.
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/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:
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 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.
3、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.
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 execution. 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 including proficiency in use of Microsoft Word, Excel and PowerPoint.
3、Strong written and verbal communication skills including good command of English language
4、Attention to detail and accuracy in work.
5、Diploma or bachelor degree;or equivalent combination of education, training and experience
CRA
Skills
? 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 environment
? Sound presentation skills
? Consultative skills
? Client focused approach to work with the ability to i nteract professionally within a client organization
? Ability to prioritize multiple tasks and achieve project timelines
? Able to take initiative and work independently
? Sense of urgency in completing assigned tasks
? Able to travel a minimum of 65% on a verage
? Holds a driving license where required
? Effective time management in order to meet daily metrics or team objectives
? Shows commitment to and performs consistently high quality work
Education
? Educated to degree level (biological science, pharma cy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience
Language Skills
? Competent in written and oral English.
Minimum Work Experience
? Previous work experience (e.g. CR Assistant, nursing, labor atory, data management) would be
advisable
药品安全经理
岗位职责：
1、建立药物安全工作的SOP体系
1）建立与药物安全有关的不良事件收集、员工和研究者培训、严重不良事件报告、定期不良事件更新报告、临床方案和报告审阅、说明书审阅、文档管理等相关SOP体系;
2）进行年度SOP回顾，必要时进行更新
2、管理和培训
1）对药物安全专员进行工作指导、检查、培训、辅导和业务管理；
2）根据需要对公司相关部门员工、研究者和CRO公司CRA进行相关SOP培训，并记录培训结果；
3）与公司相关部门协调建立建全不良事件收集渠道；
4）制定ACN药物安全工作的发展规划和年度计划；
3、审阅临床研究方案、ICF/CRF、定期安全更新报告、临床报告和说明书
1）了解国内外药品临床开发的进展及相关资料;
2）参与临床试验方案的讨论，并给出有关药物安全性方面的意见和建议；
3）审阅临床试验方案（包括PMS）、ICF和CRF，给出合理的意见和建议，并签字确认；
4）审阅并签发药物安全专员准备的定期安全更新报告
5）审阅临床试验报告和说明书的安全性内容或信息，并给出合理的意见或修改建议；
4、临床试验过程中不良事件收集和严重不良事件报告
1）根据CRA（CRO公司）提供的严重不良事件报告表准备英文报告，并在规定时限内向API PV报告; 2）对严重不良事件进行跟踪，并及时向API PV报告；
3）对于ＡＣＮ发起的临床研究，DSO应将方案中有关药品安全性的内容以英文报告给API PV，在取得临床研究报告后，将报告中药物安全性部部分的内容以英文报告给API PV.
4）对于由研究者发起并得到ACN支持的研究，督促研究者及时向DSO报告研究过程中的不良事件，DSO 在规定的时间内向API PV提交ＡＥ报告；
5）在临床试验过程中向SFDA, 试验基地及伦理委员会报告SUSAR Case;
6）与临床开发部门和CRO公司进行良好的沟通以取得支持；
5、其他
1）协助注册人员准备多中心临床试验的风险控制计划；
2）与API PV部门进行有效的沟通与交流；
3）接受API PV或监理管机构的审计
4）定期接受有关药物安全的培训，了解有关药物安全的最新动态和知识；5）完成部门经理交办的其他任务
工作要求：
知识技能
?药理学、或临床医学相关专业学士以上学位;
?与临床有关的高等知识(病理生理学、诊断、内科学、临床药理学等); ?优秀的领导和沟通协调能力
?计划能力，分析和解决问题能力;
?良好的计算机、人际关系技能;
?能够清晰、简洁、有效地通过电话和书面进行沟通；
?英语口语和书写流利;
工作经验
?5年及以上药物安全相关工作经验和管理经验;
?跨国制药公司工作经历；
?对药品安全有关法规和指南有正确的理解;
?与药品警戒领域的专家能够进行良好的沟通和联络;