赛纽仕
CRA II - Shanghai
CRA II - Shanghai
发布于 2 天前普通员工/个人贡献者
北京市
中级经验
全职员工
仅现场办公
本科
TMF
临床试验监查
Isf
Ich Guidelines
Crf核查
源文档审阅
电子数据采集
研究用药品管理
AI 估算 · 18k–28k
CRA II 岗位需2-3年经验，外资CRO在北京/上海薪资约18-28K，中等偏上，市场竞争力中等。
职位详情
关于这个职位
该职位是临床监查员（CRA II），主要负责临床试验中心的管理与监查工作，包括中心筛选、启动、常规监查和关闭访视，确保试验符合GCP和法规要求
你将与研究中心团队紧密合作，核对原始数据，管理试验用药品，并推动问题解决
适合有临床研究经验、熟悉ICH-GCP、能适应频繁出差的专业人士
最低要求
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis
工作职责
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
AI 洞察
优缺点分析
优点
- 加入全球领先的CRO Syneos Health，平台资源丰富，项目多元化
- 接触国际多中心临床试验，积累前沿药物开发经验，提升专业竞争力
- 公司提供系统的培训和职业发展路径，支持个人成长
- 需要频繁出差（高达75%），对生活平衡有较大影响
- 严格遵循SOP和法规，容错率低，需要高度细致和责任心
- 适合有1-3年临床监查经验、能适应高强度出差、希望在临床试验领域长期发展且追求专业成长的求职者
缺点 / 挑战
- 工作节奏快，需同时管理多个中心，压力较大
角色解读
- 晋升为高级CRA或Lead CRA，负责更复杂试验或团队指导
- 转向临床项目管理或临床运营管理岗位，如Clinical Project Manager
- 在CRO或药企内部向质量管理、培训或法规事务方向发展
- 负责临床试验中心的筛选、启动、常规监查和关闭访视，确保试验符合GCP和法规要求
- 核对病例报告表中的数据与原始源文件，解决数据查询，确保数据完整准确
- 管理研究用药品的接收、分发、回收和记录，监督中心合规性
- 维护研究者文件夹和试验主文件，准备并接受监管部门的稽查
- 深入理解ICH-GCP指导原则和当地药品监管法规
- 优秀的沟通、协调和问题解决能力，能与研究者、申办方等各方有效协作
- 熟练使用电子数据采集系统和临床试验管理软件
- 具备良好的时间管理和组织能力，能适应75%的出差频率
申请策略
- 了解Syneos Health的公司文化和发展方向，在面试中体现对客户协作和创新的认同
- 强调对患者安全和数据质量的重视，展示职业使命感
- 突出CRA工作经验，特别是独立负责中心管理、处理复杂问题的案例
- 量化成果，例如管理过多少个中心、按时完成监查次数、0重大偏差等
- 强调GCP知识掌握程度和培训证书，以及参与过的试验类型（Phase I-IV）
- 展示沟通和团队协作能力，例如协调多方解决数据问题的经历
- 复习ICH-GCP最新更新和FDA/NMPA法规，准备面试中的法规问答
- 熟悉电子数据采集系统（如Medidata Rave、Veeva）的操作
面试指南
- STAR法则（情境-任务-行动-结果）回答行为类问题，突出行动和结果
- 对于流程问题，先陈述标准步骤，再结合实际经验举例说明
- 针对冲突处理，展示沟通技巧和以合规为导向的解决思路
- 请描述一次你发现并解决重大方案偏离的经历
- 你如何管理多个研究中心的工作优先级？
- 解释一下源文档核查和CRF核对的具体流程
- 当研究者不配合数据清理时，你如何处理？
- 你对我们公司的了解以及为什么选择Syneos Health？
匹配度报告
62
综合匹配度
外资CRO中级CRA，成长空间大、社会价值高，但出差频繁、生活平衡较差。
适合人群
最适合重视专业成长、愿意通过高强度投入换取职业发展的求职者，不适合追求工作生活平衡的人。
最强匹配
成长发展匹配
最弱匹配
工作生活匹配
薪资福利55
成长发展85
工作生活30
使命价值80
薪资福利匹配
55较低
薪资未明确，但根据行业水平估计中等，福利未在JD中明确列出，补偿性满足度一般。
薪资信号未披露（AI估算：18K-28K/月）
成长发展匹配
85较高
公司提供明确的职业发展和培训支持，项目多样且涉及前沿药物，成长空间大。
技术前沿传统/成熟技术
技术栈ICH-GCP、电子数据采集、临床试验监查
成长机会career development and progression、technical and therapeutic area training、peer recognition、total rewards program
业务类型ambiguous
工作生活匹配
30较低
需高达75%出差，生活平衡较差，工作模式现场办公，灵活性低。
工作模式仅现场办公
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值匹配
80较高
临床研究直接改善患者健康，社会价值高；行业稳定，公司使命感强。
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号accelerate customer success、shape solutions that have the ability to dramatically impact someone’s life
创新程度稳健跟随主流
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