宜昌招聘

Clinical Research Associate / Sr. Clinical Research Associate

Job Summary

In this role, you will design, plan and implement the overall direction of clinical research projects. Your primary responsibility will be to assist the study team with all operational activities for products under clinical evaluation.

Responsibilities

• Independently be responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.

• Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products.

• Assist in the preparation of clinical reports and clinical/non-clinical sections of regulatory submissions.

• Assist with the management of key study parameters (i.e. start-up activities, enrollment, data collection, etc.).

• Responsible for management on CRO or other partners about clinical trial projects.

• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.

• 独立负责临床试验的所有活动，包括临床现场选择、研究起始访问、现场人员培训、临床数据的准确性和完整性，以及临床报告的准备和演示，对临床数据进行现场审核和临床试验。

• 设计和编写研究协议、调查人员手册、网站特定的指导手册和设计案例报告表格，以供新的和修改过的产品。

• 协助准备临床报告和临床/非临床部分的监管意见书。

• 协助管理关键的研究参数(如:启动活动、登记、数据收集等)。

• 负责在临床试验项目中对可及其他合作伙伴进行管理。

Required Knowledge, Skills, and Abilities

• Bachelor’s Degree or above of Medical related major.

• Minimum of 1 years’ experience with Medical Device or Drug, in vitro diagnostics(IVD) clinical trial experience is preferred.

• Previous Clinical Research Associate field site study monitoring experience.

• Previous hands-on experience in clinical research at either a pharmaceutical/biotech company or hospital is highly desirable.

• Good English & communication skills.

• Knowledge of GCP and CFDA guidelines.

• This is an in-house based position with frequent travel required.

本科以上学历，医学相关专业。

至少有1年的医疗设备或药物经验，有体外诊断(IVD)临床试验经验者优先。

先前的临床研究助理现场现场研究监测经验。

以前在制药/生物技术公司或医院的临床研究的实践经验是非常可取的。

良好的英语及沟通能力。

了解GCP和CFDA的指导方针。

这是一个内部的职位，需要经常出差。

丹纳赫是全球科学和技术的创新者，致力于帮助我们的客户在全球各地应对复杂的挑战和改善生活品质。我们在最前沿和富有吸引力的领域，如生命科学、环境等等，拥有众多世界一流的品牌。我们是一支全球超过71000名员工的多样化团队，遵循同一个文化 - 丹纳赫业务运营体系（DBS）,该体系引领我们始终在日益激烈的商业竞争中处于领先地位。丹纳赫2014年营业额达到199亿美金并且市值超过600亿美金，位列美国财富500强中的149位。在过去的20年中，丹纳赫的股价表现优异，超过标准普尔指数将近2000%。

在中国，丹纳赫始终保持高速增长，拥有超过6000名员工和16亿美金的营业额。二十多家中国营运公司和超过一百家的分支机构，不但为中国客户提供着全方位的产品和服务，也为卓越人才提供更好的工作机遇和职位发展平台。

了解更多信息，请访问公司网站：***************.

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including health care, environmental and etc. We are a globally diverse team of 71,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. In 2014, we generated $19.9 billion in revenue and our market capitalization exceeded $50 billion. We are ranked #149 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,000 percent.

With over 6000 associates and $1.6 billion of revenue in China, Danaher continuously achieve high growth in the market. Through more than 20 China operation companies and more than 100 subsidiaries, Danaher not only provides comprehensive products and services to China client, but also better career opportunities and development platform for talents.

For more information please visit our website at ***************.