临床研究专员岗位职责
| 适配人群 | IVD临床研究员，体外诊断医学专员，药械临床研究者 | 使用场景 | 产品上市后研究，临床试验执行，医学信息更新 |
|---|---|---|---|
| 设立背景 | 公司产品上市后要搞临床研究，得有人专门负责这事。还要把医学信息整理出来，帮市场部做推广。 | ||
| 核心职能 | 设计执行上市后临床研究。收集提炼医学信息。写文章发出去。让产品更有竞争力。 | ||
| 工作内容 | 找机构做试验。盯时间点。管预算。办伦理审批。签协议。开研究者会。整数据。写报告。 | ||
| 协作关系 | 跟医学部一起定方案。向直线经理汇报。和kol、研究者打交道。配合市场部、注册部、销售部同事。 | ||
岗位职责：
主要负责产品上市后临床研究的设计和执行以及产品医学信息的获取、提炼和发布等，目的是提升我司产品的市场竞争力，市场部可以进行有差异化推广。
(设计实验方案-找研究机构进行试验-多方协调，过程管理-整理数据，发表文章)
1、与医学部同事协作，共同设计公司赞助/支持的研究计划及研究方案的设计;
2、管理整个研究活动，包括且不限于试验点的选择、伦理委员会审核、研究协议签订、研究者会议、研究注册/备案、试验文件管理、数据核实、研究结题、研究报告的攥写和发布等;
3、试验/研究时间结点的追踪、过程管控，赞助/支持的产品研究预算的设计和管理;
4、及时了解产品相关的医学进展，获取及更新产品的医学信息、提炼和发布医学信息;
5、与kols、研究者及研究/试验点建立良好的关系;
6、与其他部门同事协作;
7、直线经理安排的其他项目任务;
任职要求：
1、临床医学/检验/分子生物学专业，硕士学历;
2、超过2年制药/体外诊断医学或临床研究工作背景优先考虑;
3、熟悉临床研究的流程，善于试验方案的设计、预算设定、试验过程管控和文献/刊物的发表。
临床研究专员岗位职责：cra临床研究专员
| 适配人群 | 临床研究专员，CRA，临床监查员 | 使用场景 | 新药临床试验，研究中心管理，监查工作执行 |
|---|---|---|---|
| 设立背景 | 新药研发要跑临床试验，得有人盯现场、查数据、保合规。 | ||
| 核心职能 | 盯研究中心日常运转，查病人入组、数据填得对不对，确保试验按规矩走。 | ||
| 工作内容 | 查原始病历、核对crf表、写监查报告、跟进问题整改、整理中心文件。 | ||
| 协作关系 | 听临床研究经理安排，和医生护士打交道，跟pm同步进度，和数据管理、统计同事对数据问题。 | ||
职位描述：
按照要求协助或负责i~iv 期临床研究中的各项工作，对新药研发流程及临床研究相关法律法规有一定了解。在临床研究经理或项目经理指导下，能够负责研究中心的日常管理工作，独立进行监查工作。
任职资格：
1. 临床医学、药学或相关专业学历，对药品管理有关法规、临床研究和临床研究监查流程有一定了解。
2. 一年以上临床研究监查工作经验，进行过独立的临床研究监查。
3. 具备一定的沟通表达能力、判断能力、应变能力及问题解决能力。
4. 良好的写作能力及组织能力，能够根据工作分配的强度及优先度进行自我调整。
5. 积极主动的工作态度，能适应长期出差。
6. 熟练的使用windows操作系统与office系列办公软件包括word、excel、powerpoint。
7. 具备一定的英语阅读及写作能力。
临床研究专员岗位职责：临床研究项目专员
| 适配人群 | 临床研究专员，IVD项目经理，CRAs | 使用场景 | IVD注册申报，体外诊断试验，多中心临床验证 |
|---|---|---|---|
| 设立背景 | 做临床试验得有人盯各国的事，不然协议、表格、站点都乱套。 | ||
| 核心职能 | 管好指定试验点，从启动到关中心全程盯，确保合规、数据准、病人入组顺。 | ||
| 工作内容 | 写方案修改稿、查站点、做监查计划、办伦理报批、签合同、开启动会、装设备、管物资、填ecrf、报不良事件。 | ||
| 协作关系 | 和研究者天天联系，向study manager汇报，跟合同组、数据管理、统计、qa一起干活，也带新人学监查。 | ||
临床研究经理-项目经理-主管-专员 main tasks responsibilities
1. contribute country specific aspects in the development of protocol， protocol revisions， amendments and crf design;
2. responsible for the management of designated sites in clinical trial including:
site assessment; preparation of the monitoring plan and execution in compliance with visit frequency and all assigned tasks throughout the study; planning and execution of study logistics plan， including eventual delegation of activities to support group; safety and proper conduct throughout the trial.
3. site specific data management;
4. prepare documentation for irb/ec submission/approval， together with study management per country specific requirements;
5. prepare and review clinical study agreements and budgets with study manager and contracts group;
6. ensure procedures are in place for appropriate enrollment of patients into the clinical trial;
7. organize investigator’s start-up meeting and study site initiation meetings， including training of the external study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with wincaev and training in the use of electronica crfs with remote data entry;8. responsible for instrument installation， check and validation (internal and external) for system study. if applicable， prepare workflow sheet for system studies， together with study management;
9. responsible for logistics of required evaluation/clinical trial material. informs and monitors sites for correct storage conditions;
10. preparation of all study binders;
11. perform investigator training (compliance technical part).
12. verify the investigator follows the approved protocol and all gcp procedures;
13. verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study;
14. key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials;
15. ensure that observations during studies are correctly tracked and forwarded to the responsible departments in xxxx;
16. verify that source data/documents and other trial records are accurate， complete， and maintained. regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops;17. communicate deviations from the protocol， sops， gcp， and the applicable regulatory requirements to the investigator;
18. interprets and evaluates results with respect to the study goals and， if necessary， discuss with the site， the study manager， eg. interruption of the study or initiation of additional measurements at the external site;
19. perform troubleshooting for unexpected results according to study manager or protocol’s requirements;
20. ensure completion and availability of study documentation， together with study management;21. adverse events， concomitant medications， and inter current illnesses are reported in accordance with the protocol;22. conduct study close-out visits according to monitoring plan;
23. ensure ecrf and wincaev are ready for database lock;
24. archive study records / database according to guidelines;
25. responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit;26. participation in project teams， global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability， practicability and sop development， to continuously improve quality and efficiency of the evaluation team and processes;
27. contribute to the content of the study report and contribute to publications for journals and congresses.
possible additional tasks for senior position holders;
28. responsible for investigator selection (accountability lies with study manager)
29. provide mentoring， including training on the job， to the new cras to ensure that their role and contribution is optimized.
basic requirements of the job
1. bio-medical related scientific degree; can vary from a bachelor， master and nursing qualifications;
2. knowledge of applicable standards an regulations for clinical trials and lab conduct (international conference on harmonization / who good clinical practice standards (ich-gcp)， ivd directives， fda regulations)
3. practical experience in study monitoring according to global standards (ich)
4. 2-5 years of clinical laboratory experience;
5. demonstrated experience in computer skills to include microsoft word， excel， and basic templates;
6. basic statistical knowledge;
7. professional use of the english language; both written and oral;
8. open and clear communicator;
9. ability to make sound decisions and analyze and solve problems;
10. conscientious and precise delivery of work even when under pressure jd 为参考。经理-专员各级别都有。
背景优先级:1 ivd 2 cro 3 器械 4 药 main tasks responsibilities
10. conscientious and precise delivery of work even when under pressure
临床研究专员岗位职责（优选3篇）
