Teresa Liu Email & Phone Number | Education • Taipei Medical University, Taipei, Taiwan M.S., Medical Laboratory Science and Biotechnology, July 2021 -Studied 1 year in master with full scholarship •Taipei Medical University, Taipei, Taiwan B.S., Respiratory Therapy, June 2020 -Best respiratory therapist intern of the Year in Ministry of Health and Welfare Shuang-Ho Hospital Work Experience PPD, TAIPEI, TAIWAN • CTC I, SEPTEMBER 2021 – PRESENT -Work closely with the project CTM and CRA for timely delivery of recurrent tasks consistently with a high degree of accuracy -Performs department, Internal, Country and Investigator file reviews as request, and documents findings in appropriate system(s). File Review in 6 different client eTMF and 15 sites at same time. -Provides system support (i.e., Activate & eTMF) and ensures system databases are always current, including, but not limited to, timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. -Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. -Assists with study-specific translation materials and translation QC upon request. -May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s). -Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. -Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites, ig. NTUH, TSGH, VGHTC, CMUH, KMUH, NCKUH. -Supports start-up team in Regulatory submissions, ig. preparing of regulatory compliance review packages. -Communicate with the team and appropriate clinical personnel regarding site issues and risks. -Ensures an efficient plan is in place for site contact and follow up. Ensures compliance with the plan and escalate concerns/non-compliance to management. Schedules of client or internal meetings. -Supports to establish site accounts, i.g. EMR, iMedidata, eCOA -Acts as a buddy during onboarding phase and provide training to new staff as needed. -Manages import licenses of clinical trials supplies and prepare documents to export.

Teresa Liu

Education • Taipei Medical University, Taipei, Taiwan M.S., Medical Laboratory Science and Biotechno...
Taiwan

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Teresa Liu’s Email teresa.liu@ppdi.com

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Teresa Liu’s Location Taiwan

Teresa Liu’s Current Industry 法馬蘇提克產品發展有限公司

Teresa Liu’s Prior Industry Taipei Medical University

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Work Experience

Ppd

Clinical Trail Coordinator

Present

法馬蘇提克產品發展有限公司

Clinical Trail Coordinator

2021-09-01 00:00:00 - Present

Taipei Medical University

Research Assistant

2020-09-01 00:00:00 - 2021-06-01 00:00:00

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FAQ About Teresa Liu

Teresa Liu is located at
Taiwan

Teresa Liu is a Education • Taipei Medical University, Taipei, Taiwan M.S., Medical Laboratory Science and Biotechnology, July 2021 -Studied 1 year in master with full scholarship •Taipei Medical University, Taipei, Taiwan B.S., Respiratory Therapy, June 2020 -Best respiratory therapist intern of the Year in Ministry of Health and Welfare Shuang-Ho Hospital Work Experience PPD, TAIPEI, TAIWAN • CTC I, SEPTEMBER 2021 – PRESENT -Work closely with the project CTM and CRA for timely delivery of recurrent tasks consistently with a high degree of accuracy -Performs department, Internal, Country and Investigator file reviews as request, and documents findings in appropriate system(s). File Review in 6 different client eTMF and 15 sites at same time. -Provides system support (i.e., Activate & eTMF) and ensures system databases are always current, including, but not limited to, timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. -Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. -Assists with study-specific translation materials and translation QC upon request. -May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s). -Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. -Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites, ig. NTUH, TSGH, VGHTC, CMUH, KMUH, NCKUH. -Supports start-up team in Regulatory submissions, ig. preparing of regulatory compliance review packages. -Communicate with the team and appropriate clinical personnel regarding site issues and risks. -Ensures an efficient plan is in place for site contact and follow up. Ensures compliance with the plan and escalate concerns/non-compliance to management. Schedules of client or internal meetings. -Supports to establish site accounts, i.g. EMR, iMedidata, eCOA -Acts as a buddy during onboarding phase and provide training to new staff as needed. -Manages import licenses of clinical trials supplies and prepare documents to export.