长沙招聘

岗位职责：

1、依据国家相关法规、研究方案、医院及公司 SOP要求，在研究者的授权下，协助研究者完成各项工作；

2、协助研究者完成伦理资料递交、临床试验机构备案等工作；

3、协助及时完成SAE相关安全报告；

4、协助研究者填写病历报告表，协助研究者完成试验各个阶段研究中心的文档收集、整理、归档；

5、协助研究者完成受试者筛选、入组、随访等工作，包括受试者招募、筛选潜在的受试者、 安排受试者访视、安排实验室检査、获取检査结果等；

6、协助研究者完成相关物资及药物的管理，包括接收、保存、分发、回收和归还，并完成相关记录；

7、协助CRA的中心监査工作，提前准备各种文档供CRA监査，及时全面的向CRA汇报研究中心进展情况；

8、协助CRA、研究者及时完成数据答疑；

9、协助研究者进行临床试验管理及相关日常工作。

岗位要求：

1、临床医学或护理等相关专业、大专以上学历；

2、一年以上临床或CRC经验，有临床试验经验者优先考虑；

3、英语四级以上，良好的英文听说读写能力；

4、较强的独立工作能力及团队合作精神；

5、具备一定的抗压能力，并会自我心理调节；

6、工作积极主动，良好的沟通及应变能力。具备良好的自我学习能力。

Job Description：

1.In accordance with relevant national regulations, protocol, SOP requirements of hospital and company, and under the authorization of the investigators, assist the investigators to complete various tasks；

2.Assist investigators in completing IRB submission and clinical trial institution filing;

3.Assist in the timely completion of SAE related safety reports;

4.Assist investigators in filling out the medical record report form, and assist investigators in completing the collection, sorting and filing of documents of site at each stage of the trial;

5.Assist investigators in completing subject screening, enrollment, follow-up, etc., including subject recruitment, screening potential subjects, arranging subject visits, arranging laboratory inspections, obtaining inspection results, etc;

6.Assist researchers in the management of related supplies and IPs, including receiving, storing, dispensing, recycling and returning, and completing relevant records;

7.Assist CRA's in site monitoring, prepare various documents in advance for CRA's monitoring, and report the progress of the site to CRA in a timely and comprehensive manner;

8.Assist CRA and investigators to complete data Q&A in a timely manner;

9.Assist investigators in clinical trial management and related daily work.

Qualifications:

1.Junior college or above in medical science， nursing or related subjects；

2.Minimum 1 year of experience as a CRC or working in clinical circumstances；clinical trial experience will be plus；

3.CET 4 or above in English，and good command of English listening, speaking, reading and writing;

4.Ability to work independently,with a team spirit;

5.Ability to working under pressure and self-regulation；

6.Positive work attitude, good communication skill and adaptability to change, and strong self-learning ability.

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