OHR Members

Dean

Chun-Jen Huang

Dean

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

Responsible for OHR business


Vice Dean

Dawn Chen

Vice Dean

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

Responsible for OHR business


Finance Officer

Tien-Chen Tseng

Finance Officer

Tel: 02-6620-2589 #15317
E-mail: tsenghui@tmu.edu.tw

1. Responsible for revenue management under the Office of Human Research, including the preparation of financial statistical reports and internal reporting, revenue structure analysis, and progress tracking.
2. Responsible for tracking and managing accounts receivable and handling payment offsets, including regular report compilation and submission.
3. Assist in setting annual financial targets.
4. Assist with other tasks assigned by team leaders.


JIRB Administration Section

Chih-Han Lin

Director

Tel: 02-6620-2589 #15312
E-mail: michael@tmu.edu.tw

1. Planning standard operating procedures and practices to prepare, review, revise and promulgate.
2. Assist the chief convener to manage meetings and Administration Office, and responsible for assigning cases.
3. Overall Management of JIRB Administration Section.

Yen-Chen Chang

Administration Staff

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

1. Domestic and international accreditation and certification preparation.
2. Financial related service and the contact window for review fee discounts.
3. Management of the official documents of the Office of JIRB Administration Section.
4. Contact window for Commission study.
5. Contact window for Compassionate Use/Specific Drug and Device Import/National Health Insurance Prior Review.
6. Consultation window for foreign student.
7. Handling studies in TMU-eJIRB system.
8. Provide consultation.

Wan-Zhen Huang

Administration Staff

Tel: 02-6620-2589 #15306
E-mail: wzhuang@tmu.edu.tw

1. Responsible for TMU-JIRB A
2. Domestic and international accreditation and certification preparation.
3. Contact window for Statistical Reports
4. Release PI account of clinical trial.gov
5. Arrange training courses
6. Handling studies in TMU-eJIRB system.
7. Provide consultation.

Yu-Jung Chen

Administration Staff

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

1. Responsible for TMU-JIRB C
2. Handling studies in TMU-eJIRB system.
3. TMU-eJIRB system account management
4. Contact window for applying a sponsor administrator account.
5. Provide consultation.

Chia-Jung Hsiao

Administration Staff

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

1. Responsible for TMU-JIRB B
2. Handling studies in TMU-eJIRB system.
3. In charge of IIT study/trial in TMU's affiliated hospital
4. Recipient of paper documents
5. Conduct official letter Management of the official documents of JIRB.
6. Provide consultation.

Yen-Ting Wang

Administration Staff

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

1. Responsible for TMU-JIRB
2. Handling studies in TMU-eJIRB system.
3. Recipient of paper documents
4. In charge of the consultation from TMU-JIRB email box
5. Contact window for access documents
6. Provide consultation.

Huei-Ching Hsu

Administration Staff

Tel: 02-6620-2589 #15308
E-mail: snoopy@tmu.edu.tw

1.The consultation window of TMU-eJIRB system operation.
2. Represented TMU institution to agree whether the study/trial can conduct in TMU.
3. Responsible for cIRB study/trial management
4. Handling studies in TMU-eJIRB system.
5. Provide consultation.


Data Safety Managing Section

Chun Yang

Director

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

1. Administrative Management and Strategic Planning for the Office of Human Research
2. Budget Coordination Management for the Office of Human Research
3. Planning and Organizing Major Events for the Office of Human Research
4. Overall Management of Data Safety Managing Section

Information Operations

Chia-Hua Sung

Administration Staff

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

1. Schedule Management for the Dean of the Office of Human Research
2. Website Management of the Office of Human Research
3. Management of the Human Research Audit System (HRAS)
4. Management of the Clinical Trial Management System (CTMS)
5. Management of Human Research Committee Meetings
6. Management of the official documents of the Office of Human Research

Ko-Hsin Hsu

Administration Staff

Tel: 02-6620-2589 #15321
E-mail: san5203386@tmu.edu.tw

1. Data Management for the Office of Human Research
2. Analysis of Clinical Trial Landscape
3. Management of the Clinical Trial Management System (CTMS)
4. Liaison for the Clinical Trial Management System (CTMS)
5. REDCap System Setup and Maintenance

Audit Operations

Wan-Rong Shieh

Administration Staff

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

1. Audit of Cases at Taipei Medical University Hospital and Shuang Ho Hospital
2. Schedule Management for Vice Dean
3. Management of Facilities and Equipment for the Office of Human Research
4. Human Research Education and Training
5. Project Management of Clinical Trial Incentive Payments
6. Project Management for Optimization of Clinical Trial Fee Standards

Shang-Ting Tsai

Administration Staff

Tel: 02-6620-2589 #15322
E-mail: 113078@w.tmu.edu.tw

1. Audit of Cases at Taipei Medical University and Taipei Municipal Wanfang Hospital
2. Support for Human Research Education and Training
3. Management of Office of Human Research Meetings
4. Execution of Tasks Related to Meetings of the Center for Human Research Protection (CHRP)


Joint Clinical Research Center

Chien-Ju Kuo

Director

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

1. Executive responsible for JCRC performance
2. Coordinate the JCRC business
3. Clinical trial budgeting management
4. JCRC member management

Clinical Operations

Hui-Hsin Cheng

Project Manager

Tel: 02-6620-2589 #15315
E-mail: leila148@tmu.edu.tw

1. Coordination of Clinical Trial Center activities across three hospitals.
2. Management and tracking of execution efficiency and quality in trials at affiliated hospitals.
3. Liaison and consultation with partner companies on trial projects.
4. Project management for EASi-KIDNEY

Calanthe Fang

Administration Staff

Tel: 02-6620-2589 #15325
E-mail: m432110020@tmu.edu.tw

1. Planning and organizing clinical trial-related training programs
2. Arranging clinical trial-related events
3. Setting up clinical trial online systems
4. Data compilation for clinical trials
5. Project management for EASi-KIDNEY

Academic Operations

John Chiang

Project Manager

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

1. Oversee the IIT project-related operations, including:
 (1) Annual solicitation and evaluation of new IIT projects
 (2) Presentation and training services
 (3) Proposal consultation, counselling and writing services.
 (4) Funding and management of IIT cases.
2. ARO counseling related business
3. CRO company project related business
4. Inventory and analysis of domestic and international clinical trial development trend.

Bruce Chiang

Administration Staff

Tel: 02-6620-2589 #15328
E-mail: 113255@w.tmu.edu.tw

1. ARO related business: writing clinical trial plans for manufacturer-sponsored IITs, international IITs, and manufacturer-commissioned cases, pre-execution related business, IRB and TFDA submissions.
2. TFDA and IRB review for EASi-KIDNEY project, including new cases and amendments.

Kelly Chang

Administration Staff

Tel: 02-6620-2589 #15327
E-mail: 113254@w.tmu.edu.tw

1. IIT project education and training and explanation meeting handling.
2. IIT programme project extension report submission and data maintenance.
3. TFDA and IRB review of EASi-KIDNEY projects, including new cases and amendments.
4. CRO company project related affairs.


Contract Operations

Andy Liu

Administration Staff

Tel: 02-6620-2589 #15323
E-mail: ayliu@tmu.edu.tw

1. The review and administration of clinical trial contract.
2. Management of IRB approval letters and duplicate requests
3. Inquiries and consultations from sponsors and CROs.

Te-Yu Kao

Administration Staff

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

1. The review and administration of clinical trial contract.
2. Management of IRB approval letters and duplicate requests
3. Inquiries and consultations from sponsors and CROs.

Pei-Chen Liao

Administration Staff

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

1. The review and administration of clinical trial contracts.
2. Management of IRB approval letters and duplicate requests
3. Affixing of the official seal to the clinical contract.


Administrative Operations

Shin-Ping Tu

Administration Staff

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

1. Execute administrative tasks for the Ministry of Health and Welfare's "Clinical Trial Development Promotion Program."
2. Coordinate management of JCRC funding.
3. Progress reports on the execution of CTC/TCTC funding.

Yi-Pei Lu

Administration Staff

Tel: 02-6620-2589 #15326
E-mail: 113263@w.tmu.edu.tw

1. Administrative operations and management of the Joint Clinical Research Center (JCRC).
2. Government program fund write-off
3. Joint Clinical Research Center (JCRC) staff recruitment.
4. Unit general affairs management operations.


Joint Biobank

Yu-Chen Yang

Director

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

1. Strategic planning of all services provided by the center Assist the services provided by the center
2. Services of microbiota culture and sequencing
3. Biobank related academic speeches and conferences
4. Collaboration with alliance hospitals.
5. Biobank quality and technical operating procedures management

Ya-Wen Hsu

Biotechnician

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

1. Biobank deposit of specimen storage processing
2. Specimen QA/QC operating
3. Specimen withdraw processing

Yi-Wen Chou

Biotechnician

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

1. Biobank deposit of specimen storage processing
2. Specimen QA/QC operating
3. Specimen withdraw processing

Yao-Lin Yang

IT Technician

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

1. Specimen Management System Maintenance
2. Clinical data processing
3. Information Management System Maintenance

Che-Yu Liu

Administration Staff

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

1. Responsible for biological materials application, cases review and charge of biological materials.
2. Making an appointment for ethice committee of joint biobank
3. Biobank related administrative services


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