叶青 张

1) Provide medical/scientific input on ongoing, or planning clinical trial. Translation, Preparation, and Review of study documents (Protocol, ICF, CRF and CSR et al.) to ensure safety, regulatory and ethical compliance. 2) Develop and execute the medical monitoring plan for assigned project, such as review of medical coding, protocol deviations, QA log, safety data et al. 3) Interact with investigators intermittently during conduct of trial to understand any recruitment and/or medical challenges and provide suggestions. 4) Involve in the project team meetings, and resolution of medical and safety related queries from sites and project team. 5) Provide the medical training to the relative study team members.