重庆招聘

Job description

The scope of responsibilities:

?       This position is expected to work collaboratively across functionally to support and implement activities associated with assigned clinical study (ies).

?       Deliver study level goals/deliverables with supervision

?       Deep understanding and familiarity with assigned study and protocol requirements

?       Support all study related activities including:

o       protocol writing, amendment, informed consent

o       provide study related data to support regulatory documents (IB, regulatory documents, etc)

o       Site and CRA training

o       Site selection and activation in collaboration with clinical operation

o       Collaborate with the clinical operation to define study activities, deliverables, instructions relating to assigned studies (e.g. IVRS, central lab, site monitoring plan, lab manual, etc)

?       Support investigator meeting, DMC meeting, thought leader interactions with minimum supervision

?       Collaborate with CRP and data manager to develop Data Review Guideline

?       Provide disciplined data review per Data Review Guideline to ensure high-quality data of the study on an ongoing basis.

?       Acquire the ability to interpret and analyze data to support study needs

?       Develop proficiency in applying data reviewing tools (excel, JReview, RAVE, etc)

?       Develop working knowledge in ICH/GCP and drug development including statistics, disease, competitive landscape, and compounds.

Responsibility

Education/Working Experience requirements:

?       Degree in life sciences (medicine, pharmacy, biology); 0-3 years of working experiences in clinical research/development or equivalent

?       Advanced degree (Medical Degree or master degree) preferred

?       Demonstrated interests in clinical research

?       Committed to learn and grow in a dynamic team environment

思路迪（3DMed）2010年成立于上海，是最早在中国展开肿瘤精准医疗检测服务的公司之一，经过长期的耕耘发展，从集团公司分拆之后的思路迪诊断，已经是中国肿瘤精准诊断领域领军企业之一，目前在中国、美国和新加坡拥有超过800名员工。
目前，思路迪诊断已经构建了集成设备工程、电气、生命科学技术、材料学和数据分析为一体的综合性研发平台，具备实现精准诊断领域研发制造全自动化操作系统的能力。其拥有自主研发的封闭式全自动化NGS文库制备平台，以及前瞻创新的肿瘤早期诊断标志物（外泌体）开发平台，促成了基于这些平台的多个突破性辅助诊断和伴随诊断产品正在临床试验阶段或即将进入临床试验；公司传染病平台开发基于自动化和POCT化的产品服务，覆盖全球传染病诊疗网络。公司还拥有第三方医学检验所，其拥有行业权威的CAP/CLIA资质，所覆盖的精准诊断营销网络超过70%的核心三甲医院，服务对象超过800家医院，提供从肿瘤早期诊断到靶向治疗、免疫治疗、再到术后动态监测的精准医疗全程管理产品和服务。