Alice Yu Email and Phone Number

Trial management

❖ Involved in entire clinical trial process, including site feasibility, Site start up, Site initiation visit, IP management, Routine monitoring, DBL, quality control, site summary report, Site close out and NMPA inspection.❖ As Lead CRA of one project From SSU to SMV for about 1 year. Lead CRA of another cancer project from Nov2021 to present, assist study project manager to manage study progress and mentor junior CRA.❖ As primary CRA, participated in 2 times NMPA inspection, 1 time sponsor audit and 2 times QCV , and no any major finding was identified.❖As primary CRA of one study’s leading site, obtained EC approval for protocol amendment within 0.5 month and achieved study’s milestone of first initiation visit and FPV globally.❖ As mentor, give guidance to Junior CRA on company process and monitoring skills.

1. Site selection，HGRAO application,SIV，SMV，COV， NMPA inspection.2. In accordance with the contract schedule, Organize investigator meetings.3. Coaching 2 new colleagues, Assisting in project management.4.Assist the register department to generate the clinical application materials.5.Contract negotiation, provide the department's budget to the director and pay for the site fee.6.As the company's key employee , participate in the "monitor's actual skills training", "clinical research design training", "clinical research summit meeting of the new drug China-US double declare " and so on.

1. Select sites, contact with institutions&investigator to confirm cooperation intentions.2. According to the information and relevant literature provided by the R&D department, draft IB,clinical research protocol and informed consent.3. Organize the investigator meeting.4. Monitor the sites to ensure the study is conducted in accordance with the protocol, GCP and relevant regulations.5. Check the TNM stage of the Tumour Project carried out by the company.