富启睿
FSP CRA I (Beijing)
FSP CRA I (Beijing)
发布于 大约 14 小时前普通员工/个人贡献者
北京市
初级经验
全职员工
仅现场办公
本科
临床研究
Cra
Crf
Ctms
Sae
临床监查
临床试验
数据管理
英语
AI 估算 · 10k–15k
初级CRA，跨国CRO背景，北京薪资中等偏高，需出差但基础薪资尚可。
职位详情
关于这个职位
这是一份临床研究监查员（CRA I）职位，主要负责临床试验现场监查与中心管理，确保试验按照法规和方案执行，保护受试者权益，并保证数据真实完整
日常工作包括中心筛选、启动、监查和关闭，以及协调供应商和内部团队，适合有半年以上相关经验、希望深耕临床研究领域的初级人员
最低要求
Qualifications (Minimum Required):
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Basic knowledge of Regulatory Guidelines.
Basic understanding of the clinical trial process.
Fluent in local office language and in English, both written and verbal.
Experience (Minimum Required):
Six (6) months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.).
Basic understanding of Regulatory Guidelines.
Ability to work within a project team.
Good planning, organization, and problem-solving skills.
Good computer skills with good working knowledge of a range of computer packages.
Works efficiently and effectively in a matrix environment.
Valid Driver's License.
工作职责
Summary of Responsibilities:
Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
General On-Site Monitoring Responsibilities.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data.
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
Ensure audit readiness at the site level.
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports.
Interact with internal work groups to evaluate needs, resources, and timelines.
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsible for all aspects of registry management as prescribed in the project plans.
Undertake feasibility work when requested.
Participate in and follow-up on Quality Control Visits (QC) when requested.
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
Assist Senior CRA with managing investigator site budgets.
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
Assist with training, mentoring and development of new employees, e.g., co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
Perform other duties as assigned by management.
优先资格
Preferred Qualifications Include:
One (1) or more year's additional experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
months on site monitoring experience.
Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
Attention to detail.
Methodical approach to work.
Understanding of medical and clinical research terminology and clinical research processes.
An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
Understanding of the principles of ICH GCP, ISO 14155 (if applicable) and regulatory requirements.
Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications.
Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
Experience using a clinical trial management system (CTMS).
For medical device positions, experience in providing customer service to device end users.
AI 洞察
优缺点分析
优点
- 跨国CRO平台，接触国际多中心试验，积累全球标准的临床研究经验
- 临床研究行业需求稳定，专业性强，经验越久越有价值
- 公司有系统的培训和导师制度，有助于新人快速成长
- 兼顾内外沟通，能锻炼项目管理、协调和医学知识综合能力
- 需要频繁出差，工作强度较大，对生活节奏有影响
- 涉及大量细节性文档工作，要求极高的耐心和细致度
- 适合对临床医学和药物研发有热情，做事严谨细致，并愿意接受频繁出差的求职者
缺点 / 挑战
- 行业法规严格，出错风险大，需持续学习保持合规认知
角色解读
- 从CRA I起步，积累监查经验后可晋升为CRA II、高级CRA，独立负责更复杂的中心
- 向临床项目管理方向发展，成为Local Project Coordinator或临床研究经理
- 未来可转向质量保证、培训或法规事务等相邻领域，拓展职业宽度
- 负责临床试验中心的筛选、启动、日常监查和关闭，确保试验按方案和GCP规范执行
- 通过对原始数据和病例报告表（CRF）的核对，保证试验数据的真实性和完整性
- 跟踪严重不良事件（SAE）报告，协调研究者、伦理委员会和监管机构的沟通
- 作为申办方和试验中心之间的桥梁，管理试验物资、预算和供应商，并参与项目协调工作
- 熟悉ICH GCP、当地法规和临床试验流程，具备基本的医学或药学知识
- 良好的沟通和人际交往能力，能与研究者、护士及客户团队高效协作
- 细致严谨的工作态度，擅长数据核查和问题解决
- 流利的中英文书面和口头表达能力，熟练使用办公软件和CTMS系统
申请策略
- 了解Fortrea的客户和服务模式，以及临床试验行业动态
- 在面试中强调多任务管理能力和适应出差的态度
- 突出有半年以上相关实习或工作经验，如CRA、CRC、研究护士或数据管理经历
- 强调对GCP和法规的了解，可在简历中列出具体培训或证书
- 体现中英文沟通能力，特别是医学英语读写水平
- 展示注重细节和问题解决能力的案例，如数据清理或监查项目
- 熟悉ICH GCP和当地临床试验法规，建议提前学习相关指南
- 掌握CTMS系统和常见办公软件（如Excel）的基本操作
面试指南
- 按情境-行为-结果（STAR）法则回答行为类问题，突出具体行动和成果
- 对于GCP问题，先阐述原则，再结合实践举例说明如何操作
- 对于出差类问题，强调灵活性和项目管理能力，体现积极态度
- 请谈谈你对ICH GCP核心原则的理解，以及如何在监查中落实？
- 你如何处理监查中发现的严重数据问题或方案偏离？
- 描述一次你需要同时管理多个中心或任务的经历，如何安排优先级？
- 为什么选择CRA职业，你对出差怎么看？
- 如何与研究者建立良好合作关系？
职位点评
62
综合评分
跨国CRO初级CRA，临床研究价值感强，但出差多、WLB一般，薪资未明示。
从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。
更适合这类人
适合看重社会责任和长期职业发展、能够接受出差和现场工作的求职者。
表现最好
使命价值
相对薄弱
工作生活
薪资福利60
成长发展70
工作生活45
使命价值75
薪资福利
60中等
薪资水平未在JD中披露，但跨国CRO通常提供有竞争力的薪酬和稳定福利，不过频繁出差可能影响性价比感知。
薪资信号未披露（AI估算：10K-15K/月）
成长发展
70中等
公司提供培训、导师和明确的职责发展，但JD中未明确晋升路径，成长潜力主要靠个人积累。
技术前沿非技术岗（不适用）
成长机会training、mentoring、development
业务类型ambiguous
工作生活
45较低
工作为现场监查，且明确要求频繁出差，对工作生活平衡影响较大，没有弹性办公安排。
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
75中等
临床研究对药物开发和患者健康有直接贡献，虽然JD未明说使命，但行业社会价值较高。
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
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