• 招聘类型：社招
• 工作性质：全职

职位描述

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.

任职条件

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

职位要求

• 学历要求：硕士及以上
• 工作经验：无
• 外语要求：不需要