Mingkai Wu Email and Phone Number

Responsible for the Phase I and II solid tumor project as a clinical research associate, the main job responsibilities are as follows:1) Monitor study activities to ensure compliance with protocols and with all relevant policies and institutional policies.2) Assist in investigator study site selection, connect with principal investigator, EC, and IRB to ensure the intention of project acceptance.3) Assist in study start-up-related work which includes creating the contract, accomplish the CTMS system requirements, conduct the Initial meeting and prepare trial-related materials to ensure the site initiation.4) Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure "Good Clinical Practice", and conduct close-out visits.5) Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on the management of incidents.6) Managed documentation, including clinical research data worksheets, shared drive, and clinical research files (ISF, TMF).7) Organized and maintained the complete records for each study, including the case reports, drug dispensation records, and regulatory paperwork.8) Prepared study reports and annual review documents.9) Continuously monitored active studies to verify compliance with facility’s protocols and regulatory standards, helping to protect personnel from legal issues.10) Verify drug accountability logs and storage requirements.11) Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines12) EDC system data verification13）site-close related issues

1)Responsible for writing the English research plan and communicating clinical matterswith the director in time2) Responsible for the weekly work summary report of the CRA, the regulatory andcoordination department, including but not limited to 4 national filing projects that havebeen declared3)Preparation for meeting related to project management, supervising and processing theprogress of the project by the inspector4)Docking with CRO company outsourcing and outsourcing projects related to clinical trialresearch

Responsibilities: 1) Prepare the experimental items for the lab session including solvents buffer and labellingthe hazards substance2) Communicate with lecturer and students to organize the lab room and class room 3) Routine preparation of laboratory including co-ordinate with lecturer, replenish the stock,clean the used experimental items.Achievements:Organise all the lab items and lecture progress effectively and ensure the safety oflaboratory