广州招聘

Responsibilities:
1. Work directly with physicians and research staff at the site, through project management and on-site and/or remote monitoring activities, to ensure that the clinical studies are conducted, recorded, and reported in accordance with the clinical investigation plan (CIP), written Cook procedures, and applicable Chinese and international standards and regulatory requirements.
2. Assist in the development and/or peer review of study supporting documents and submissions to regulatory authorities, such as annual reports or patient summaries.
3. Track IRB/Ethics Committee approval and renewals; prepare and respond to IRB/Ethics Committee submissions or correspondence.
4. Track study-specific documentation, such as insurance, agreements, CVs, etc.
5. Identify and report to project management any issues which may need attention at a particular investigative site, and provide leadership in the resolution of identified issues and support resolution as needed.
6. Generate detailed and timely reports following site visits, as required.
7. Responsible for establishing and maintaining the quality system, SOPs, and clinical docket for Cook China Clinical Function, for processing documents associated with clinical investigation activities, and/or other clinical activities assigned by the Sponsor or Clinical Affairs Manager.
8. Assist in the development and/or peer review of study supporting documents and submissions to regulatory authorities, such as annual reports or patient summaries.
9. Perform clinical document translations, as needed.

Qualifications:
1. Must have prior experience in regulatory and/or clinical studies, preferably in the medical device industry and have a degree in scientific, medical or engineering.
2. Have the willingness and capability to handle multiple projects and responsibilities and demonstrated ability to manage projects effectively and efficiently.
3. Must have outstanding work ethic and strong personal discipline.
4. Knowledge and understanding of regulations and applicable industry standards governing medical device clinical studies.
5. Strong attention to detail.
6. Demonstrated ability to carry out job duties independently and in a team setting and complete job duties timely.
7. Ability to present a professional and personable demeanor in phone, written, and face-to-face communications.
8. Ability to travel as needed to support clinical studies.
9. Strong oral and written communication skills in both Chinese and English.

库克医疗（Cook Medical）
库克公司于1963年创建于美国印第安纳州的Bloomington。最初以生产血管介入产品为主，也是最早涉足此领域的公司之一。Seldinger法血管穿刺、经皮腔内血管成形术等日后对介入诊断与治疗产生根本性影响的技术的推广与普及背后，都有库克公司的卓越贡献。

从建立之初，库克公司便奉行“服务患者，着眼未来”的宗旨，通过自主研发以及与全球顶级科研机构、医院及专家的合作，不断推出更多创新性医疗产品，服务于患者健康。始终保持在微创诊断与治疗领域的领先地位。

如今，库克公司已发展成为全球规模最大的私人医疗器械公司（private company）之一，形成以医疗器械研发与生产为核心，并涉足生物制药、基因与细胞疗法以及生物科技领域的产销一体化跨国集团公司。公司在美国、欧洲和澳大利亚等地设有9大医疗器械生产及研发中心，并在全球主要国家与地区均设有分支机构。产品线也从最初的血管介入迅速扩展，目前主要涉及主动脉介入、心脏介入、急诊医学、消化病学、放射学、外周血管介入、骨穿刺与肿瘤学、外科与软组织修复、泌尿科学以及辅助生殖技术、妇科及产科学等领域，并在多个学科处于领先地位。

库克（中国）医疗贸易有限公司
Cook (China) Medical Trading Co., Ltd.
库克公司于1996年开始进入中国市场，依托强大的研发和品牌实力，迅速成为最受医生欢迎的品牌之一。2008年，库克公司投资5000万人民币，在上海成立全资子公司——库克（中国）医疗贸易有限公司，以满足国内及亚洲地区迅速增长的医疗器械市场需求。新建于上海外高桥保税区的配送中心占地面积将分期扩充至3000平方米；占地600平方米的客服中心位于上海市区，将负责处理来自我国大陆、香港、台湾，以及韩国、日本、新加坡、马来西亚、印度、菲律宾、泰国、印度尼西亚、柬埔寨、越南等地的订单需求。

如今的库克中国集仓储、物流、配送、客服及销售等各项职能于一体，将作为一个位于上海、面向亚洲医疗器械市场的区域共享服务中心，服务于国内及亚洲市场。

公司主业：www.cookmedical.com


公司网站：http://www.cookmedical.com

联 系 人：Laura Chen

地 址：上海市天钥桥路333号腾飞大厦1503室
          

邮政编码：200030