Ya-Wen Hsu Email and Phone Number

• Perform monitoring of clinical trial to ensure that clinical studies are conducted in compliance with GCP, study protocol and PPC SOP.• Conduct routine monitoring for clinical trials. Reviewing study CRFs completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries.• Documenting site visits and issues in reports and follow-up letter to the site.• Facilitating effective communication between investigative sites, the… Show more • Perform monitoring of clinical trial to ensure that clinical studies are conducted in compliance with GCP, study protocol and PPC SOP.• Conduct routine monitoring for clinical trials. Reviewing study CRFs completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries.• Documenting site visits and issues in reports and follow-up letter to the site.• Facilitating effective communication between investigative sites, the client and PPC.• Responding to company, client and federal regulatory requirements/audits.• Contributing to the project team by mentoring new members, assisting in preparation of project communications and tools, and sharing ideas and suggestions with team members.• To maintain the business relationship with customers to ensure customer awareness of the deliverables.• To obtain the IRB approval for clinical trial complementation.• To support other colleagues in the complementation of ongoing project or other services, and actively participate in various works and activities.• To participate in sponsor audits and the regulatory inspections.• To edit variety of documents and SOPs, to comply with company and division policies, SOPs, instructions or procedures.• To handle other temporary tasks. Show less

•Clarified the specificity of candidate antibodies under four projects by different analysis methods•Designed and scheduled the experiments for each project to complete the tasks efficiently •Organized the experiment data and concluded the results to project leaders on time, which made project leaders determine the project proceeding.