-
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
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
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
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
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<
/p>
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
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
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
< br>)
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