长沙招聘

岗位职责：

1、根据试验方案、合同规定的工作范围、SOP和GCP的要求进行研究中心筛选、启动、监查和关闭访视；

2、同时负责多个方案、研究中心和治疗领域内的研究中心监查工作；

3、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。将质量问题汇报给负责的PM和/或直线经理；

4、通过追踪注册申报和批复、招募和入选、病例报告表（CRF）完成和递交、以及数据疑问产生和解决的情况，管理所负责研究中心的进展；

5、创建和维护与研究中心管理、监查访视的发现以及行动计划相关的文件，递交访视报告和其他所需研究文件；

6、协助项目经理完成样品发放、合同付款、总结报告等工作；

7、完成直线经理和/或项目经理（PM）分配的其他工作；

8、发生严重不良事件，及时向项目经理报告。

任职要求：

1、医药相关专业本科及以上学历,硕士优先考虑；

2、至少1年以上临床监察工作经验，具有2-3期临床试验中任意1期项目操作经验；

3、良好的临床研究相关知识，了解适用的法规要求；

4、通过公司培训掌握方案要求的知识；

5、优秀的口头和书面沟通能力，优秀的组织和解决问题的能力；

6、有效的时间管理技巧，能够同时处理冲突工作的能力；

7、项目涉及至少1个适应症，肿瘤和自身免疫适应症优先。

Job Responsibilities:

1. Conduct research center screening, initiation, monitoring and closing visits according to the test plan, the scope of work specified by the contract, the SOP and the requirements of the GCP;

2. At the same time, it is responsible for the inspection of research centers in various programs, research centers and therapeutic fields;

3. Assess the quality and completeness of the work of the research center and determine whether the research center is conducting research in accordance with the program and applicable regulations. Report quality issues to the responsible PM and/or line manager;

4. The management is responsible for the progress of the research center by tracking registration and approval, recruitment and selection, completion and submission of case report forms (CRF), and data question generation and resolution;

5. Create and maintain documents related to the management of the research center, the findings of the audit visits, and the action plan, and submit the visit report and other required research documents;

6. Assist the project manager to complete sample distribution, contract payment, summary report, etc.

7. Complete other tasks assigned by the line manager and/or project manager (PM);

8. Serious adverse events occur and report to the project manager in a timely manner.

job requirements:

1. Bachelor degree or above in medicine related major, master's degree is preferred;

2. At least 1 year of clinical monitoring experience, with experience in any phase 1 project in 2-3 clinical trials;

3. Good knowledge of clinical research and understanding of applicable regulatory requirements;

4. Master the knowledge required by the program through company training;

5. Excellent verbal and written communication skills, excellent organization and problem-solving skills;

6, effective time management skills, ability to handle conflict work at the same time;

7. The project involves at least one indication, and the tumor and autoimmune indications are preferred.

三生制药集团是一家集研发、生产和销售为一体的生物制药领军企业，致力于基因工程重组蛋白质类药物的研究与开发。主要涵盖肿瘤科、自身免疫性疾病、肾科、代谢、皮肤科以及其他相关治疗领域。股票代码：*******。三生制药是以科技创新为长期目标的中国生物科技公司，全球拥有3,000余名员工，现有生产基地分别位于沈阳、上海、深圳、杭州和意大利科莫。营销网络覆盖国内32个省份，国际远销至20多个国家，是一家具创新能力和发展潜力的医药企业。