富启睿
FSO CRA II (Ji'nan)
FSO CRA II (Ji'nan)
发布于 1 小时前普通员工/个人贡献者
全职员工混合式弹性办公临床研究
临床研究
Ctms系统
Ich Gcp
Sae管理
中英双语
临床监查(Cra)
临床试验
医学合规
合规审计
源数据核查(Sdv)
值不值得投
68综合评分
综合评分 68
外企CRO中阶监查岗，体系化培训完善、专业成长快，但出差强度大、WLB一般
从薪资福利、成长发展、工作生活和使命价值四个维度综合评估，方便横向比较。
薪资怎么样
1.6万
比临床研究中位数低
发布情况
新岗位 · 今天发布
公司情况
这家公司招聘很活跃
56 个在招 · 其中临床研究 47 个
市场机会
选择面较广
北京 · 临床研究 · 约 160 个在招
职位详情
关于这个职位
负责临床试验项目的站点管理与现场监查，确保研究符合ICH GCP规范及公司SOP
需独立完成源数据核查、受试者保护、药物管理及合规文档审核，并协助团队推进项目进度
最低要求
拥有相关健康专业领域的大学或学院学位（如护士执照），或具备同等工作经验
深入理解ICH GCP指南及当地法规要求
熟悉监查流程
掌握临床试验基本流程
中英文书面及口语流利
外部候选人需具备至少2年临床监查经验
工作职责
Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
Prepares and implements project plans related to Clinical Monitoring responsibilities.
Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
Ensures adherence to global quality control and CRA performance metrics.
Ensures audit readiness at site level.
Acts in the project role of a Lead CRA as assigned.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
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.
Travel, including air travel, may be required and is an essential function of the job.
Prepare and submit accurate and timely trip reports.
Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
Track IP shipments and supplies, as needed.
Track and follow-up on serious adverse events as assigned.
Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
Present training content for site initiation.
Assist with training of new employees (e.g., co-monitoring).
All other duties as needed or assigned.
优先资格
熟悉Fortrea站点监查SOP
在医疗、临床、制药、实验室、研究、数据分析或技术写作等相关领域有1年以上额外经验
具备I期临床试验监查经验
生命科学或护理学背景
掌握CTMS等电子临床系统使用经验
具备良好的细节关注度、逻辑思维、跨部门沟通能力及保密意识
AI 洞察
优缺点分析
优点
- 依托上市跨国CRO平台，接触前沿新药研发项目，职业履历含金量高
- 具备医学/护理背景，能适应高频出差，追求外企规范化培训与稳定职业发展路径的求职者
缺点 / 挑战
- 需承担约60%的高频出差任务，长期奔波对体力与家庭生活平衡构成挑战
角色解读
- 从CRA II逐步晋升为Senior CRA或Lead CRA，积累独立带教与复杂项目管理经验
- 负责去医院/研究中心进行现场监查，核对原始数据与病例报告表的一致性，确保试验全程符合GCP法规
- 熟练掌握ICH GCP规范及国内临床试验法规，具备扎实的源数据核查与质疑处理能力
申请策略
- 提前了解富启睿在肿瘤、罕见病或器械领域的优势管线，面试时展现对特定治疗领域的兴趣
- 突出2年以上独立监查经验，量化管理的站点数量、受试者规模及数据核查准确率
- 补充GCP最新法规更新知识，熟悉NMPA及FDA双报审要求差异
面试指南
- 采用STAR法则（情境-任务-行动-结果），聚焦“发现问题-风险评估-沟通协调-闭环整改”逻辑
- 请分享一次你发现严重数据偏差或方案违背的经历，你是如何处理的？
- 面对研究者不配合监查或拖延签字，你会采取哪些策略推进项目？
- 如何在保证数据质量的前提下，高效完成每月数十家站点的监查任务？
- 复习ICH E6(R3)最新指南及国内《药物临床试验质量管理规范》核心条款
职位点评
薪资福利65
成长发展82
工作生活48
使命价值78
薪资福利
65中等
薪资未明确披露，但作为上市跨国CRO企业，通常提供符合市场水准的薪酬及完善福利。
薪资信号未披露（AI估算：1.2千–2.0万/月）
成长发展
82较高
提供系统的SOP培训与带教机制，具备向Lead CRA或项目经理发展的清晰路径。
技术前沿传统/成熟技术
技术栈ICH GCP、CTMS、eClinical systems、SDV
成长机会Assist with training of new employees (e.g., co-monitoring)、Acts in the project role of a Lead CRA as assigned
业务类型ambiguous
工作生活
48较低
需频繁出差（60%），且可能涉及非标准工时，对通勤和休息有一定影响。
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
78中等
医药研发外包服务支撑新药上市，具有明确的医疗健康社会价值。
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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