南京招聘

职位描述

1. 通过规范的监查过程，保证临床试验按国家GCP要求和试验方案进行；
2. 负责临床试验的监查工作，确保所有试验严格按照临床试验方案、公司标准操作程序和国家法规进行；
3. 对所负责的研究中心进行全面的监查联络管理，按时完成临床试验在该中心的启动、执行及结束工作；
4. 负责临床试验当地医院的协调、监查与质量控制、进度督促、报告、文件管理等；
5. 检查并报告试验进度和质量、病例报告表填写、试验用药品使用、药品不良反应等各方面情况，发现问题、分析问题、提出解决方案并实施；
6. 定期归纳并提交监查报告；填写相关报告及试验记录，确保数据真实准确、完整无误；
7、与临床医生沟通并共同协商解决出现的问题，协调研究项目负责人、临床医生、辅助科室、临床基地、患者等各方关系；
8. 完成领导交办的其他工作。

任职要求：

1. 临床医学或医药学相关专业，本科及以上学历；
2. 一年以上CRA工作经验，有良好且相关背景的应届生也可；
3. 熟悉药品临床试验及GCP等相关法规；
4. 具有良好的英文读写及口语能力，能达到4级以上为佳；
5. 有良好的人际关系和良好的沟通及语言表达能力；
6. 能够适应经常出差。

上海百试达医药科技有限公司是为国内外医药和医疗器材企业提供高质量临床研究专业服务的合同研究组织（CRO），是国内领先的医药研发服务外包承接机构。公司临床研究服务分布在药品、医疗器械、生物制品等领域，为客户提供专业化的技术解决方案和技术服务。

上海百试达业务范围包括临床试验的设计、组织、运作和管理，如I-IV 期药物临床试验和医疗器械临床试验项目的策划和筹备、方案撰写、基地筛选、临床监查服务、药物管理、数据管理和生物统计、研究报告撰写。公司还提供药品和医疗器械注册和医学咨询和代理、流行病学观察性研究、医药市场研究和研究者、CRA 和其他临床研究专业人员的培训等。

上海百试达拥有资深的专业研究团队，主要研究人员均具有外资制药企业药物研发部和临床研究部工作经验。具有国际化、标准化的业务运作流程和科学严谨的质量保证体系，谙熟国际多中心临床试验和国内各种类型临床试验项目的运作和管理。此外，百试达还在临床医学，临床药理学和生物统计领域拥有一大批专家网络资源，并通过高质量的各类人员和项目培训不断扩大这一网络，从而保证各类临床项目的快速和高质量的完成。

公司的合作客户包括知名跨国制药公司和医疗器械企业、国内研发型制药企业、医药科研院所以及专业学术团体等。
公司总部位于上海，在北京、广州、成都设立分支机构，服务范围覆盖全国多个中心城市和区域；在美国波士顿设有联络处和QA 办公室。

Bestudy are one of the leading contract research organizations (CRO) that provides high-quality clinical studies service for domestic and overseas pharmaceutical and medical device enterprises in the country. We provide professional technical solutions and services for our customers' clinical studies in the fields of medicine, medical device and biological products.

We are specializing in design, organization, operation and management of clinical trials, eg, planning, preparation, protocol writing, site selection and due diligence, clinical monitoring service, investigational product management, data management, bio-statistics and study report writing for phase I-IV drug and medical device clinical trial project. It also provides medicine and medical device registration and medical consulting and agent, epidemiological observational research, drug market research and the training of study professionals including investigators, study nurse, CRAs and other clinical trial staffs.
We have professional research team with a majority of members who worked years in R&D and clinical research departments of multinational pharmaceutical companies. With the world leading and standard business process and scientific quality assurance system, Bestudy has accumulated proficient experience in the operation and management of multicenter clinical trial projects and other clinical trial projects in China. In addition, we boast a wealth of expert resources in clinical medicine, clinical pharmacology and bio-statistics and try to further extend through personnel development program and project training to make sure various clinical projects are completed with speed and high quality.

We have built the partnership with multinational pharmaceutical and medical device enterprises, R&D-oriented pharmaceutical enterprises and pharmaceutical research institutes and academic societies.

Headquartered in Shanghai, we have subsidiaries in Beijing、Chengdu and Guangzhou with business operations in many central cities and regions across the country and opened international business and QA office in Boston, USA.