临床监查员培训生 Clinical Research Associate Trainee

公司部门: Clinical Development

工作地点:北京

发布日期:2021-11-03

招聘人数:15人

职位类型:生物制药/医疗器械

职位描述:

1. Receive intensive training in regulations, ICH-GCP and SOPs, learn clinical trail related knowledge and understand the process and requirements of site selection, site initiation, monitoring and close out visit. Receive training on soft skills, such as good communication, effective cooperation, etc.

接受法规和SOP集中培训,学习了解临床试验及ICH-GCP的相关知识, 学习监查技能、RCA & CAPA等相关内容,包括选点、启动、监查、中心关闭4大访视的流程和要求。接受软技能的培训,如良性沟通、高效合作等。

2. Assist CRA for sites monitoring related works in multiple sites.

协助监查员做好研究中心的监查工作,中心管理工作。

3. Assist CRA for supporting development of project subject recruitment plan on a per site status. Work with site to adapt, drive and track subject recruitment plan in the line with project needs to enhance predictability.

协助监查员制定项目受试者的招募计划。根据项目需要与研究中心合作,调整、推动和跟踪受试者招聘计划,以提高招募进度的可预见性。

4. Learn how to 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.

学习评估研究中心工作的质量和完整性,确定研究中心是否是按照方案和适用的法规进行研究,确定受试者的权益收到保护。将质量问题汇报给负责的PM和/或直线经理。

5. Assist CRA for site study financial management.

协助监查员做好研究中心的研究财务管理。

6. Collaborate and liaise with study team members for project execution support as appropriate.

与其他职能部门共同合作。

7. Could complete other tasks assigned by superior.

可以完成上级交给其它的工作。

任职条件:

1. Full-time bachelor degree or above, major in medicine, pharmacy, nursing and life science

全日制大学本科及本科以上学历,医学、制药、护理及生命科学相关专业;

2. SSU,CTA,CRC etc. with less than 1 year of clinical experience.

一年以内相关临床经验的SSU,CTA,CRC等;

3. English listening, speaking, reading and writing clinker, CET4 or equivalent is preferred; Proficient in using office software in English environment.

英语听说读写熟料,英语4级或同等水平为佳;能在英文环境下熟练使用办公软件;

4. Good communication skills, good logical thinking and problem solving skills.

良好的沟通能力,良好的逻辑思维与解决问题能力。

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