精鼎医药
Clinical Research Associate II - Velavigo Shanghai
Clinical Research Associate II - Velavigo Shanghai
发布于 大约 3 小时前普通员工/个人贡献者
上海市
中级经验
全职员工
混合式弹性办公
本科
医疗、制药与临床研究
ICH-GCP
CTMS
EDC
IVRS
Problem Solving
Clinical Research
AI 估算 · 15k–25k
CRA II在上海跨国CRO，需要经验和出差，薪资中等偏上。
职位详情
关于这个职位
该职位为临床研究助理II，负责管理临床试验中心，确保试验方案合规执行
主要工作包括中心筛选、启动、监查和关闭，与研究者建立合作关系，解决现场问题，并保证数据质量
需要出差，适合有临床研究经验且善于沟通协作的专业人士
最低要求
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
工作职责
Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
Build relationships with investigators and site staff.
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
Address/evaluate/resolve issues pending from the previous visit, if any.
Follow-up on and respond to appropriate site related questions.
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
Conduct remote visits/contacts as requested/needed.
Generate visit/contact report.
Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
Assess & manage test article/study supply including supply, accountability and destruction/return status.
Review & follow-up site payment status.
Follow-up on CRF data entry, query status, and SAEs.
Conduct on-site study-specific training (if applicable).
Perform site facilities assessments
Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
Show commitment and perform consistent high-quality work.
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
Provide input and feedback for Performance Development Conversation(s).
Proactively keep manager informed about work progress and any issues.
Develop expertise to become a subject matter expert.
Work in a self-driven capacity, with limited need for oversight.
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
AI 洞察
优缺点分析
优点
- 在跨国CRO工作，能接触国际多中心试验，积累全球视野和行业人脉
- 公司提供系统培训，技能提升快，专业认证机会多
- 职位稳定性高，临床研究行业持续增长，长期需求旺盛
- 严谨的合规要求和高强度文档工作，需注重细节
- 适合有临床研究背景、喜欢独立工作又能团队协作、愿意出差并追求专业成长的求职者
缺点 / 挑战
- 频繁出差，对生活平衡和体力要求较高
- 工作压力大，需要同时管理多个中心，处理紧急问题
角色解读
- 从CRA II向高级CRA发展，积累更多项目经验和中心管理能力
- 可晋升为Lead CRA或项目管理角色，负责协调整个研究团队
- 转型为临床运营管理、培训或质量保证等方向，拓宽职业路径
- 负责临床试验中心的全面管理，包括中心筛选、启动、监查和关闭，确保试验合规进行
- 与研究者及中心人员建立良好合作关系，提供培训和支持，解决现场问题
- 审核数据质量，管理试验文档，确保符合ICH-GCP和当地法规要求
- 扎实的临床研究知识和GCP法规理解，能独立进行现场监查
- 优秀的沟通和人际交往能力，能够与研究者、团队和客户高效协作
- 良好的组织协调和问题解决能力，能同时管理多个中心并应对突发状况
- 熟练使用CTMS、EDC等临床试验管理系统及MS Office
申请策略
- 在求职信中表达对临床研究质量的热情和责任心
- 准备具体事例展示如何应对复杂中心问题
- 突出临床研究经验，特别是中心管理、监查和法规符合性案例
- 强调沟通协作成果，如成功解决中心问题或提高数据质量
- 列出熟悉的具体系统和工具（如CTMS、EDC、IVRS）
- 复习ICH-GCP最新指南和当地法规
- 提升Excel和数据分析能力，用于监查报告
- 提前了解PAREXEL的公司文化和项目类型
面试指南
- 使用STAR方法（情境、任务、行动、结果）结构化回答行为问题
- 对专业知识问题，先陈述原则再举例说明
- 请描述一次你如何解决中心不合规问题的经历
- 如何处理多个中心的时间冲突和优先级？
- 对ICH-GCP的理解以及在实际工作中的应用
- 如何与研究者建立信任关系？
- 面对数据质量问题时，你的处理流程是什么？
- 回顾过往项目中的典型挑战和解决方案，准备好案例
职位点评
68
综合评分
跨国CRO的CRA II，社会价值高、发展稳定，但出差频繁、WLB较差。
更适合这类人
适合追求职业意义感和专业成长，且能接受频繁出差和一定工作压力的求职者。
表现最好
使命价值
相对薄弱
工作生活
薪资福利75
成长发展70
工作生活40
使命价值85
薪资福利
75中等
薪资属于行业中等水平，跨国企业福利完善，但出差较多可能抵消部分满意度。
薪资信号未披露（AI估算：15K-25K/月）
成长发展
70中等
有明确的技能成长路径，但晋升速度取决于项目机会，培训资源丰富。
技术前沿传统/成熟技术
技术栈CTMS、EDC、IVRS、ICH-GCP
成长机会Performance Development Conversation、subject matter expert
业务类型profit_center
工作生活
40较低
需要大量出差，工作灵活性有限，WLB较差。
工作模式混合式弹性办公
办公地点未明确
加班情况JD含高强度暗示词
使命价值
85较高
临床研究直接促进新药开发，具有较高社会价值，行业前景稳定。
行业发展稳定成熟行业
社会影响正向社会影响力较高
创新程度稳健跟随主流
Watch Jobs