北京招聘

工作职责:

临床部门管理、临床项目管理

1. The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and

reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable, Regulatory requirements.

2. Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines

3. Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites

4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

5. Provides regular site status information to team members, trial management, and updates trial management tools

6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations

7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed

9. Performs essential document site file reconciliation

10. Performs source document verification and query resolution

11. Assesses IP accountability, dispensation, and compliance at the investigative sites

12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines

13. Communicates with investigative sites

14. Updates applicable tracking systems

15. Ensures all required training is completed and documented

16. Be assigned logistical support tasks by CTM for Investigator Meetings

任职资格:

1. 1 to 4 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical /BE research experience

2. Knowledge of ICH and local regulatory authority regulations regarding drug

3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)

公司简介

美迪斯沃（北京）医药科技有限公司，由业内专业人士组建，秉承“以真诚与科技为客户创造价值”的服务理念；帮助合作伙伴预测并有效降低新产品投资风险与市场推广风险，为中国优秀医药企业研发提供全方位解决方案。

领导人为协和医学院流行病与卫生统计博士背景，17年GCP临床经验，曾就职于凯维斯、PPD。

公司优势：

1.整体解决优势： 提供临床研究整体解决方案

2.核心团队优势： 平均10年以上GCP临床研究经验

3.质量保障优势： 完整的质量保障体系

4.专家资源优势： 千名合作专家资源

5.信息资源优势： 研发、生产、临床全方位信息

6.服务网络优势： 覆盖全国主要区域

美迪斯沃（北京）医药科技有限公司，由业内专业人士组建，秉承“以真诚与科技为客户创造价值”的服务理念；帮助合作伙伴预测并有效降低新产品投资风险与市场推广风险，为中国优秀医药企业研发提供全方位解决方案。
    领导人为协和医学院流行病与卫生统计博士背景，17年GCP临床经验，曾就职于凯维斯、PPD跨国CRO企业。
服务项目：
1. 申报资料撰写、医学设计、医学翻译
2. 临床试验：I-IV期药物临床试验、器械临床试验

公司优势：
1.整体解决优势： 提供临床研究整体解决方案
2.核心团队优势： 平均10年以上GCP临床研究经验
3.质量保障优势： 完整的质量保障体系
4.专家资源优势： 千名合作专家资源
5.信息资源优势： 研发、生产、临床全方位信息
6.服务网络优势： 覆盖全国主要区域


Med-S (Beijing) Medical Technology Company is a contract research organization (CRO) . Med-S works with the commitment to consistent quality and execution, exceptional customer-aligned service and constant innovation to speed the overall execution of clinical trials. Med-S’ strategy is to bend the time and cost curve of drug development and optimize value for our customers.

The funder of Med-S has a MD degree of Epidemiology and Biostatistics of the Peking Union Medical College who has 17 years experience of clinical research and funded Med-S following more than 10 years with KendleWits and PPD.

Med-S focus on/in:
1.    Providing contract personnel for clinical development relative position;
2.    Medical writing and translation;
3.    Providing medical report for on-sale drugs using hospital HIS data;
4.    SMO;
5.    Services on Phase I-IV clinical trials;
6.    Services on clinical trials for medical device, diagnostic reagent products;
7.    Patient enrolment.

Our superiority:
1.    One-stop solution: we provide customer special one-stop solutions for clinical trial.
2.    Core service team: member of the core service team has an average of 10 years experience in GCP clinical trials.
3.    Quality assurance system: has comprehensive QA system.
4.    Expert resource: well cooperated with near 1000 clinical experts and keep cooperation.
5.    News resource: news related to development, production, and clinical trials.
6.    Site network: have sites in main cities in China.