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Senior Clinical Research Associate
1.5-2万
人 · 本科 · 3-4年工作经验 · 性别不限2024/12/28发布

捷泰广场

公司信息
辉瑞(中国)研究开发有限公司

外资(欧美)/10000人以上

该公司所有职位
职位描述
1. Perform site selection, initiation, monitoring and close-out visits in
accordance with contracted scope of work and good clinical practice.
2. If applicable, accountable for supporting development of project subject
recruitment plan on a per site basis. Work with sites to adapt, drive and track
subject recruitment plan in line with project needs to enhance predictability.
3. Administer protocol and related study training to assigned sites and
establish regular lines of communication with sites to manage ongoing project
expectations and issues.
4. Evaluate the quality and integrity of study site practices related to the
proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues as appropriate.
5. Create and maintain appropriate documentation regarding site management,
monitoring visit findings and action plans by submitting regular visit reports,
generating follow-up letters and other required study documentation.
Qualifications
Must-Have
* Bachelor's Degree
* 3+ years' experience
* Experience in clinical trial administration
* Demonstrated success/results in prior roles including matrix organization
* Demonstrated knowledge of quality and regulatory requirements across a
range of different countries
* Knowledge of International Conference on Harmonization Good Clinical
Practices and local regulations
* Knowledge of applications used in the clinical trials
* SOP compliance knowledge and expertise on all relevant SOPs
* Effective verbal and written communication skills, and must be fluent in
English
* Proficiency in Microsoft SharePoint, SharePoint Designer etc
Nice-to-Have
* Master's degree
* Relevant therapeutic area experience
* High level of project management skills

Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Medical

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