长沙招聘

Responsible for performing study site management activities according to GCP, Roche SOPs, and procedures related to site start up, initiation, patient enrollment, protocol adherence, CRF compliance, data quality and final site close-out for clinical trials so that they meet specified ethical, scientific, regulatory needs. Developing and maintain site and investigator relationships.

按照GCP、罗氏SOPs和流程的要求，负责临床研究中心的管理工作，包括项目的准备，启动, 病人入组, 方案的遵守，CRF完成，临床实验的数据质量和最后的研究中心关闭，以符合伦理，科学，和法规的要求, 并发展和维护与研究中心及研究者的关系.

Pre-Study/Start up Site Management Activities

研究前/中心启动管理活动

§ Contribute to the site and investigator selection process for their area of responsibility by making appropriate recommendations

通过适当的推荐, 选择所负责区域的中心和研究者

- Identify potential sites, investigators and site staff

确定有潜力的中心,研究者和中心人员

- Provide site-level information for the country recruitment plan.

为全国的入组计划提供研究中心的信息

- Evaluate site facilities and staff to ensure that investigative site meets ICH – GCP guidelines, local regulatory requirements, protocol and Roche specific criteria for study conduct

评估研究中心设备和人员以确保研究中心符合ICH-GCP的指导方针,当地法规部门的要求,方案和罗氏特定的研究指导标准

- Provide feedback on monitoring related issues during development of the monitoring plan

在监查计划的产生过程中就监查相关问题提出建议

- Assist and provide feedback on sites issues during site contract development and negotiation process

在研究中心合同的发展和商议过程中就研究中心问题提出建议

§ Establish site-level recruitment strategy/plan

建立研究中心的入组计划和策略

§ Ensure required documents, e.g. subject informed consent(s) and protocol, are approved by the applicable local Ethics Committee(s)

确保当地伦理委员会所要求的文件,如知情同意书和方案得到批准

§ Ensure all required study start-up documentation and supplies (drug and non-drug) is in place and the site is able to start on time and according to plan

确保所要求的启动文件和研究供给 (药物和非药物)存放在适当的地方, 确保研究中心能准时且按计划地启动.

§ Establish investigator file and submit essential documents to trial master file

建立研究者文件夹和递交原始文件给研究主文件夹

§ Ensure adequate contract is signed and payment is defrayed according to contract

确保合同签署和按照合同支付款项

§ Ensure timely site initiation in line with project timeline

确保按照项目时间表及时启动研究中心

§ Organize the site initiation workshop and participate in investigator meeting and performs required site training

组织研究中心启动会,参加研究者会议, 并按要求进行研究中心的培训

§ Build and maintain positive relationships with the site and investigators

建立和维护与研究中心和研究者间的良好关系

- Communicate in an effective, consistent, and timely manner

有效和及时的交流

- Take ownership of site issues that arise during start-up phase and ensures they are appropriately resolved

在启动阶段主动去了解研究中心的问题, 并合理地解决

§ Create site information in AIMS/CTMS and project tracking tools on site level

在AIMS/CTMS中建立研究中心信息和在研究中心建立项目跟踪工具

§ Complete timely reports/correspondence to record issue, action plan and resolution

及时完成报告或通过邮件联系, 以记录研究中心问题, 进一步计划和解决方法

Study conduct site monitoring activities

研究中心监查活动

§ Complete site recruitment according to recruitment strategy/plan

按照入组的策略/计划完成研究中心入组

- Evaluate site recruitment activities per the site-level recruitment plan during enrollment phase

在入组阶段评估每个研究中心的入组

- Identify and addresses recruitment issues and/or needs with site staff on an ongoing basis

在研究进行过程中和研究中心人员确认入组问题和需求, 并予以解决

§ Carries out monitoring activities, on-site visits or remote communication, in line with monitoring plan, ensuring adherence to protocol, ICH - GCP guidelines and local regulations.

按照监查计划执行监查活动, 进行研究中心访视和远程沟通,以保证遵循方案, ICH-GCP指导方针和当地法规

- Ensure adequate informed consenting is conducted before any procedures

在执行任何筛选程序前确保知情同意过程的进行

- Perform SDV during on-site monitoring visits according to the protocol SDV plan

按照方案原始数据核查计划在研究中心监查访视过程中进行原始数据核查

- Perform site-level drug accountability (ensuring proper handling, storage, administration, record-keeping and disposition) and emergency codes check

进行研究中心药物清点(确保适当操作,储存,管理,记录保存和发放)和紧急揭盲核对

- Verify storage and shipment of biological samples and other protocol specific diagnostics requirement

核实储存和生物样本的出口,及其它方案中特定的要求

- Verify site is transmitting data to Roche or is recording data and resolving discrepancies according to agreed upon timelines

在一致认可的时限, 核实研究中心传输到罗氏的数据，或正在记录数据, 并解决数据差异

- Maintain and update investigator file, submit essential documents to trial master file

维护和更新研究者文件夹，递交原始文件到研究主文件夹

§ Verify timely, complete and accurate reporting of SAE/Pregnancy Forms. Ensure site receives all safety information from Roche (SUSAR and SSR reports, as per local regulations, and Investigational Brochures) and submits these reports, as appropriate, to the local ethics committee/Health Authorities

及时核实完成的严重不良事件/怀孕汇报记录表的准确报告。确保研究中心从罗氏收到所有的安全信息（SUSAR和SSR报告，按照当地法规和研究者手册）, 并递交这些报告到当地伦理委员会/卫生健康机构。

§ Submit update study information (e.g. protocol, subject informed consent form, regular study progress report) to the applicable local Ethics Committee(s) and get approval within time frame

递交更新的研究信息到当地伦理委员会和在规定时间内得到批准（如：方案，知情同意书，定期研究进展报告）

§ Assess ongoing training needs of all site personnel and takes appropriate actions to ensure necessary training is performed in a timely manner

评估正在进行的所有研究中心人员的培训需求，有效而及时地保证必要培训的进行

§ Update site information in AIMS/CTMS and project tracking tools on site level

在AIMS/CTMS更新研究中心信息和在研究中心更新项目跟踪工具

§ Complete timely reports/correspondence to record issue, action plan and resolution

及时完成报告或通过邮件联系, 以记录研究中心问题, 进一步计划和解决方法

§ Ensure timely and accurate payment to site according to contract and progress

保证

Conducts Study Site Close-Out Activities

研究中心关点活动按照合同和研究进展及时和准确支付款项到研究中心

§ Ensure proper return and disposition of all study-related supplies and equipment

保证归还和发放所有研究相关的供给和设备

- Perform final reconciliation of essential documents between investigator files and trial master file. Submit outstanding essential documents to trial master file

- 执行研究者文件夹和研究主文件夹中原始文件的最终清点。递交重要的原始文件到研究主文件夹

- Perform final site-level drug or non-drug accountability and reconciliation and ensure return/destruction on local level

进行最终研究中心药物或非药物计数清点，确保研究中心归还/销毁。

- Ensure investigators understand requirements for archiving the investigator files and have the capability to archive for the designated period of time

确保研究者了解研究者文件夹的归档要求，并在指定期限内做好归档

§ Notify site and EC of the completion of the study and submit study reports as requested

按要求通知研究中心和伦理委员会研究已结束, 并递交研究报告

§ Ensure site information in AIMS/CTMS and project tracking tools is complete

确保AIMS/CTMS中研究中心信息和项目追踪工具完成

§ Ensure site reports and correspondence is complete

确保研究中心报告和信件的完成

§ Ensure site payment is defrayed according to contract and deliverables

按照合同支付研究中心的款项

Project Management Activities

项目管理的职责

§ Partial working time could be spent on small-scale or non-priority clinical trials management activities refer to Project Leader’s Job Responsibilities as requested under line manager’s support, as a part of achieving personal development in the CRA position.

部分工作时间可能因需要被安排在小型或非重点的临床研究项目的管理职责上，履行项目负责人的职责。直接主管会帮助其工作。这些项目管理的职责是做为临床监察员个人发展的重要部分。

1. Qualification and Experience 能力与经验

At least 1.5-2 years clinical operation monitor experience for senior position.

对高级职位至少1.5－2年临床研究监察员的工作经验

No special requirement for junior position

对初级职位无特殊要求

Education/Qualifications教育程度/所获资格证书

Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)

具有生物医学/自然科学或相关的学科的学士学位（例如理学士，注册护士，药学等）

Leadership Competencies领导者胜任力

Job Required Competencies岗位所需胜任力

Good knowledge in GCP for senior position

对高级职位要求具有良好的GCP知识

Good command of written and verbal English

拥有良好的英文书写和口语能力

Good communication and organization skills

良好的沟通和组织技巧

Good and proactive working attitude

良好、积极的工作态度

Value importance of teamwork

认知团队工作的价值观

Ability to work independently

有独立工作的能力

Travel needed

需要出差

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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