CRA

20-30万元/年

市辖区

刷新时间：2021-12-20

职位描述

一、职位描述：

(一), SUMMARY OF POSITION:

Performs and works on all aspects of the clinical monitoring and site management process along with the CRO. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability. Ensures audit readiness and develops collaborative relationships with investigational sites. May also work on other clinical projects or clinical studies to assist the Site Leader or Clinical Study Managers.

与CRO公司一起执行和处理临床监测和现场管理流程的各个方面。进行远程或现场访问，以评估协议和法规遵从性，并管理所需的文档。作为现场过程专家，确保试验按照批准的方案、ICH-GCP指南、适用法规和SOP进行，以保证受试者的权利、健康和数据的可靠性。确保审核准备就绪，并与调查地点建立合作关系。也可能从事其他临床项目或临床研究，以协助现场负责人或临床研究经理。

(二), DUTIES AND RESPONSIBILITIES职责描述:

1, Monitors/co-monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.

采用基于风险的监控方法监控/共同监控研究者现场，应用根本原因分析（RCA）、批判性思维和解决问题的技能来识别现场流程故障和纠正/预防措施，以使现场合规并降低风险。

2, Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.

通过现场和远程监控活动，通过SDR、SDV和CRF审查（如适用）确保数据准确性。

3, Assess investigational product through physical inventory and records review.
通过实际库存和记录审查来评估试验药。

4, Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved, and that the data is being recorded in a timely manner.

使用经批准的商务写作标准，及时将观察结果记录在报告和信函中。迅速将观察到的缺陷和问题上报给临床管理层，并跟踪所有问题直至解决。可能需要在监测访问与调查地点之间保持定期联系，以确认正在遵守协议，先前确定的问题正在得到解决，并且数据正在及时记录。

5, Conducts monitoring tasks in accordance with the approved monitoring plan. Ensures a shared responsibility with other project team members or CRO on issues/findings resolution. Investigates and follows-up on findings as applicable.

根据批准的监测计划执行监测任务。确保与其他项目团队成员或首席风险官共同负责问题/结果的解决。调查并跟进调查结果（如适用）。

6, Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Site Leader, Clinical Team Manager (CTM), or CRO by email or through teleconferences.

通过电子邮件或电话会议向现场负责人、临床团队经理（CTM）或CRO提供多个现场的潜在趋势更新，并讨论其管理的潜在策略。

7, Participates in Investigator Meetings as necessary.

必要时参加研究者会议。

8, Identifies potential investigators to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.

确定潜在调查人员，以确保合格调查地点的可接受性。根据相关程序启动临床试验点，以确保符合方案、监管和ICH GCP义务，并在必要时提出建议。确保试验结束和试验材料的检索。

9, Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

根据ICH-GCP和适用法规，确保所需的基本文件完整、到位。根据项目规范进行现场文件审查。

10, Contributes to the local team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements and share potential solutions for improvements.

通过指导新成员、协助编制项目出版物/工具（包括知情同意书、CRF指南和监测计划）以及与团队成员分享想法/建议，为当地团队做出贡献。必要时协助临床团队进行项目培训。确定潜在流程改进的领域，并分享潜在的改进解决方案。

11, Provides trial status tracking and progress update reports to the Site Leader, CTM, or CRO as required. Ensures study systems are updated as per the protocol, manuals, and guidelines. Perform QC check of reports generated from the different clinical systems where required.

根据需要向现场负责人、CTM或CRO提供试验状态跟踪和进度更新报告。确保研究系统按照方案、手册和指南进行更新。根据需要对不同临床系统生成的报告进行QC检查。

12, Facilitates effective communication between investigative sites, project team, and CRO through written, oral, and teleconferences.

通过书面、口头和电话会议促进调查现场、项目团队和首席风险官之间的有效沟通。

13, Maintains and completes administrative tasks such as uploading information/documents to systems, stamping of contracts, and requesting budget approval for new projects.

维护和完成行政工作，如上传信息/文件到系统，加盖合同章，申请新项目的预算批准。

14, Attend internal company meetings, prepare Powerpoint presentations/weekly reports, and provide updates at teleconferences.

参加公司内部会议，准备Powerpoint演示文稿/每周报告，并在电话会议上提供最新信息。

15, May perform additional tasks or research information as assigned by the Site Leader or CTM for new company initiatives, projects, or studies.

可执行现场负责人或CTM为新公司计划、项目或研究分配的额外任务或研究信息。

二、职位要求：

Education/work Experience教育/工作经验:

Pharmacology, pharmaceutical science, and life sciences. Preferring Masters or Doctorate degrees

药理学、药学和生命科学。硕士或博士学位优先。

Minimum 3 years of monitoring experience

至少3年的监测经验

Adequate knowledge of GCPs, clinical trial design, regulatory processes, and global clinical development process

充分了解GCPs、临床试验设计、监管流程和全球临床开发流程

Proficiency in English (written and verbal)

英语熟练（书面和口头）

Excellent Powerpoint, Word, and Excel skills出色的Powerpoint、Word和Excel技能

三、PHYSICAL AND MENTAL REQUIREMENTS身心需求：

Ability to multitask and prioritize tasks 能处理多项任务和处理优先任务

Highly organized 高度组织化

Open, effective, and proactive communication and negotiation skills 有开放、有效、主动的沟通和谈判技巧

Problem solving skills 解决问题的能力

Maintain composure under pressure and conflict resolution 在压力下保持镇定并解决冲突

Ability to follow verbal or written instructions and use of effective verbal communications

能够遵守口头或书面指示并使用有效的口头沟通

Adapts to change, adjust change and grasps information quickly; Attention to details

适应变化，调整变化，快速掌握信息；注重细节

四、OTHERS (License/Certification, Travel requirements, etc) 其他（执照/证书、出差要求等）:

Requires some travel including visiting other SK locations, Investigator meetings, site visits and/or travel for annual scientific meetings or conferences.

需要一些旅行，包括参观其他SK地点、研究员会议、现场访问和/或年度科学会议或会议的旅行。

其他要求

招聘人数：1人
职能类别：临床监查员CRA

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。