OHR Members

Dean

Chun-Jen Huang

Dean

Tel:02-6620-2589 #15300
Email: cjhuang@tmu.edu.tw

Lead the strategic planning and business development of the Office of Human Research

Substitute: Dawn Chen, Vice Dean


Vice Dean

Dawn Chen

Dawn Chen

Vice Dean

Tel: 02-6620-2589 #15301
Email: dawnchen@tmu.edu.tw

Manage the business operation and project delivery of the Office of Human Research

Substitute: Chun Yang, Director


Finance Officer

Tien-Chen Tseng

Finance Officer

Tel: 02-6620-2589 #15317
Email: tienchen@tmu.edu.tw

1. Manage revenue and monitor progress for the Office of Human Research
2. Track accounts receivable, reconcile payments, and compile financial reports
3. Plan annual financial targets

Substitute: Shu-Wen Chen


JIRB Administration Section

Wan-Zhen Huang

Director

Tel: 02-6620-2589 #15312
Email: wzhuang@tmu.edu.tw

1. Oversee all administrative functions of the JIRB Administration Section
2. Support the Chair of the Joint Institutional Review Board (JIRB) in managing board affairs, assigning reviews, and coordinating administrative operations
3. Manage the revision and issuance of standard operating procedures and guidelines
4. ClinicalTrials.gov related services

Substitute: Yen-Chen Chang

Yen-Chen Chang

Administration Staff

Tel: 02-6620-2589 #15310
Email: ms.chang@tmu.edu.tw

1. Prepare for domestic and international accreditations and audits
2. Manage financial operations of the JIRB Administration Section, including consultation for bulk submission discounts
3. Process special cases, including delegated reviews, special imports, compassionate use, and NHI pre-approval reimbursement projects
4. Manage cases in the central IRB system (c-IRB)

Substitute: Yu-Jung Chen

Yu-Jung Chen

Administration Staff

Tel: 02-6620-2589 #15305
Email: tree0218@tmu.edu.tw

1. Serve as the administrative liaison for the Joint Institutional Review Board: TMU-JIRB C
2. Manage user accounts for the TMU-eJIRB system, including vendor administrator account applications

Substitute: Chia-Jung Hsiao

Chia-Jung Hsiao

Administration Staff

Tel: 02-6620-2589 #15309
Email: jennyhsiao@tmu.edu.tw

1. Provide user support and maintain the TMU-eJIRB system
2. Manage and maintain the electronic informed consent (eConsent) system
3. Handle matters related to TMU institutional consent

Substitute: Yen-Ting Wang

Yen-Ting Wang

Administration Staff

Tel: 02-6620-2589 #15307
Email: yentingwang@tmu.edu.tw

1. Serve as the administrative liaison for the Joint Institutional Review Board: TMU-JIRB
2. Receive and process paper-based submissions
3. Manage the section’s shared email inbox
4. Handle applications for access to case-related documents

Substitute: Chia-Jung Hsiao

Oi-Ki-Camil Tsang

Administration Staff

Tel: 02-6620-2589 #15311
Email: 114239@w.tmu.edu.tw

1. Serve as the administrative liaison for the Joint Institutional Review Board: TMU-JIRB C
2. Provide English-language consultation for human research review matters

Substitute: Shin-Yi Huang

Shin-Yi Huang

Administration Staff

Tel: 02-6620-2589 #15306
Email: encorina0617@tmu.edu.tw

1. Serve as the administrative liaison for the Joint Institutional Review Board: TMU-JIRB A
2. Compile various statistical reports, including preparation for domestic and international audits and accreditations
3. Plan and organize educational training programs
4. Manage and maintain the automated training management (ATM) system

Substitute: Oi-Ki-Camil Tsang


Data Safety Managing Section

Chun Yang

Chun Yang

Director

Tel: 02-6620-2589 #15302
Email: sheep456789@tmu.edu.tw

1. Manage schedules for the Dean and Vice Dean of the Office of Human Research
2. Coordinate and manage the Office of Human Research’s departmental budget
3. Plan and organize large-scale events for the Office of Human Research
4. Responsible for the operations of the Data Safety Managing Section

1st Substitute: Chia-Hua Sung
2nd Substitute: Wan-Rong Shieh

Chia-Hua Sung

Administration Staff

Tel: 02-6620-2589 #15303
Email: kakas@tmu.edu.tw

1. Responsible for the audit of human research projects at TMU Hospital
2. Manage the Office of Human Research websites
3. Administer the Human Research Audit System (HRAS)
4. Schedule, execute, and manage meetings of the Human Research Committees

1st Substitute: Wan-Rong Shieh
2nd Substitute: Chun Yang, Director

Wan-Rong Shieh

Administration Staff

Tel: 02-6620-2589 #15304
Email: kaoru45200@tmu.edu.tw

1. Responsible for the audit of human research projects at Shuang Ho Hospital
2. Conduct training programs on human research auditing
3. Manage official communication and correspondence for the Office of Human Research
4. Maintain and manage facilities and equipment of the Office of Human Research

1st Substitute: Shang-Ting Tsai
2nd Substitute: Chun Yang, Director

Shang-Ting Tsai

Administration Staff

Tel: 02-6620-2589 #15322
Email: 114042@tmu.edu.tw

1. Responsible for the audit of human research projects at TMU and Wan Fang Hospital
2. Conduct training programs on human research auditing
3. Schedule, execute, and manage internal meetings of the Office of Human Research
4. Coordinate meeting-related tasks for the Center for Human Research Protection (CHRP)

1st Substitute: Wan-Rong Shieh
2nd Substitute: Chia-Hua Sung



Joint Clinical Research Center

Chien-Ju Kuo

Director

Tel: 02-6620-2589 #15318
Email: m406097001@tmu.edu.tw

1. Responsible for the operations of the Joint Clinical Trial Center
2. Coordinate clinical research center activities across the three affiliated hospitals
3. Review clinical trial budgets for the three affiliated hospitals
4. Manage staff performance and development of the Joint Clinical Research Center

Substitute: John Chiang

Clinical Operations

YuTing Yeh

Project Manager

Tel: 02-6620-2589 #15315
Email: yyeh@tmu.edu.tw

1. Coordination of clinical trial center operations across the three TMU-affiliated hospitals
2. Management and tracking of trial execution efficiency and quality across all affiliated hospitals
3. Liaison and consultation with collaborating sponsors

Substitute: Yun-Jo Tsao

Yi-Fong Chen

Project Manager

Tel: 02-6620-2589
Email: slugcousin7682@tmu.edu.tw

1. Coordination of clinical trial center operations across the three TMU-affiliated hospitals
2. Management and tracking of trial execution efficiency and quality across all affiliated hospitals
3. Liaison and consultation with collaborating sponsors

Substitute: Ru-Hsuan Liu

Ru-Hsuan Liu

Clinical Trial Assistant

Tel: 02-6620-2589 #15396
Email: a03765@tmu.edu.tw

1. Assist with pre-trial preparation and document submission
2. Track trial execution progress across all affiliated hospitals

Substitute: Yu-Chi Liao

Yun-Jo Tsao

Clinical Trial Assistant

Tel: 02-6620-2589 #15324
Email: ra0357@tmu.edu.tw

1. Assist with pre-trial preparation and document submission
2. Track trial execution progress across all affiliated hospitals
3. Clinical trial IRB submission and preparation of interim reports

Substitute: Sky Chung

Sky Chung

Clinical Trial Assistant

Tel: 02-6620-2589 #15328
Email: ra0567@tmu.edu.tw

1. Assist with pre-trial preparation and document submission
2. Track trial execution progress across all affiliated hospitals

Substitute: Yun-Jo Tsao

Yu-Chi Liao

Clinical Trial Assistant

Tel: 02-6620-2589
Email: ra1148@tmu.edu.tw

1. Assist with pre-trial preparation and document submission
2. Track trial execution progress across all affiliated hospitals

Substitute: Ru-Hsuan Liu

Ting-Chun Lin

Study Coordinator

Tel: 02-6620-2589
Email: 114319@w.tmu.edu.tw

Support the execution of clinical trials at all affiliated hospitals

Substitute: Yun-Ting Chuang

Yun-Ting Chuang

Study Coordinator

Tel: 02-6620-2589
Email: a04448@tmu.edu.tw

Support the execution of clinical trials at all affiliated hospitals

Substitute: Ting-Chun Lin

Shih-Jung Huang

Study Coordinator

Tel: 02-6620-2589
Email: ra1055@tmu.edu.tw

Support the execution of clinical trials at all affiliated hospitals

Substitute: Yun-Ting Chuang

Administrative Operations

Shin-Ping Tu

Administration Staff

Tel: 02-6620-2589 #15399
Email: 112123@tmu.edu.tw

1. Execute administrative tasks for the Ministry of Health and Welfare’s “Innovative Excellence Program for Clinical Trials” Project
2. Process reimbursements for government-funded projects
3. Manage training and talent development programs for clinical research practitioners

Substitute: Chien-Ju Kuo, Director

Academic Operations

John Chiang

Project Manager

Tel: 02-6620-2589 #15319
Email: chiang1029@tmu.edu.tw

1. Oversee overall operations of Investigator-Initiated Trials (IIT) programs
2. Provide administrative and academic support for IIT programs
3. Guide and manage Academic Research Organization (ARO) services
4. Analyze and assess trends in clinical trial development

Substitute: Chien-Ju Kuo, Director

Kelly Chang

Administration Staff

Tel: 02-6620-2589 #15327
Email: ra0329@tmu.edu.tw

1. Execute submission processes for the EASi-KIDNEY project
2. Plan and conduct clinical trial-related training programs
3. Maintain the electronic document management system for clinical trials
4. Responsible for tracking and coordinating ARO-related business activities
5. Responsible for managing and maintaining the REDCap electronic data capture system

Substitute: John Chiang

Sandrine Chang

Administration Staff

Tel: 02-6620-2589 #15325
Email: 114275@w.tmu.edu.tw

1. Organize and conduct IIT-related training sessions and briefing events
2. Submit and maintain continuation reports and documentation for IIT programs
3. Planning and implementation of community health education related to clinical trials
4. Responsible for managing international collaborative IIT projects

Substitute: Kelly Chang

Contract Operations

Te-Yu Kao

Administration Staff

Tel: 02-6620-2589 #15314
Email: kty1105@tmu.edu.tw

1. Review operations and account management of the clinical trial contract submission management system
2. Provide consultation on clinical trial contract terms and conditions
3. Manage user permissions for the Clinical Trial Management System (CTMS)
4. Coordinate cross-functional project execution

Substitute: Pei-Chen Liao

Pei-Chen Liao

Administration Staff

Tel: 02-6620-2589 #15320
Email: 113236@w.tmu.edu.tw

1. Review operations and seal application processing in the clinical trial contract submission management system
2. Manage the dissemination for copies of IRB approval letters
3. Manage quotation records in the CTMS system
4. Handle contract execution for large-scale international IIT projects

Substitute: Te-Yu Kao

Financial Operations

Shu-Wen Chen

Administration Staff

Tel: 02-6620-2589 #15321
Email: 114221@w.tmu.edu.tw

1. Responsible for expense reimbursement and account management related to clinical trials.
2. Regularly generate income and expense statements along with settlement reports
3. Serve as the financial contact to ensure timely transactions
4. Ensure all payments comply with internal audit standards and external contract requirements

Substitute: Tien-Chen Tseng


Joint Biobank

Yu-Chen Yang

Director

Tel: 02-2736-1661 #7199
Email: can_0131@tmu.edu.tw

1. Oversee strategic planning and operations of the Joint Human Biobank
2. Offer consultation for biospecimen application cases
3. Plan and conduct training programs related to biobank operations
4. Manage quality and technical standard operating procedures for biobank activities

Substitute: Che-Yu Liu

Ya-Wen Hsu

Biotechnician

Tel: 02-2736-1661 #7197
Email: a89824704@tmu.edu.tw

1. Handle specimen intake procedures for the Joint Human Biobank
2. Perform quality control and assurance for biospecimens
3. Manage biospecimen release operations

Substitute: Yi-Wen Chou

Yi-Wen Chou

Biotechnician

Tel: 02-2736-1661 #7194
Email: laura0103@tmu.edu.tw

1. Handle specimen intake procedures for the Joint Human Biobank
2. Perform quality control and assurance for biospecimens
3. Manage biospecimen release operations

Substitute: Ya-Wen Hsu

Yao-Lin Yang

IT Technician

Tel: 02-2736-1661 #7194
Email: yaoliny@tmu.edu.tw

1. Maintain the biospecimen management system (CIBS)
2. Process clinical data
3. Maintain information management systems

Substitute: Che-Yu Liu

Che-Yu Liu

Administration Staff

Tel: 02-2736-1661 #7193
Email: h155216@tmu.edu.tw

1. Manage biospecimen applications, committee reviews, and service fee processing
2. Organize and support the Joint Human Biobank Ethics Committee
3. Handle administrative operations for the Joint Human Biobank and its three affiliated sub-biobanks

Substitute: Yao-Lin Yang


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