1.         TMF/eTMF Support:

Ÿ   Set up the eTMF system/ paper binder at the initial phase of the clinical trial.

Ÿ   Assist Study Team Leader (STL) in TMF/eTMF management including eTMF uploading, TMF archival at study/country/Site level*.

Ÿ   Perform technical check for TMF documents upon receipt*, ensuring the document format meet the SOP requirement.

Ÿ   Lead the TMF Quality Check (QC) activity by involving cross-functional team members

2.         Country/Site Support:

Ÿ   Submission Package

ü  Support preparation of the RA/EC/HGR submission package under the guidance from PM.

Ÿ   Equipment and Others Supplies Support:

ü  Responsible for non-drug supply of clinical sites, from order creation to shipment depending on study needs.

ü  Prepare for supply receipt and distribute to CRA for site signature.

ü  Coordinate equipment calibration with CRAs at the end of the study.

Ÿ   Finance Support

ü  Obtain Finance’s approval, signature of the legal representative and company seal for study related contracts within the timeline.

ü  Support Study Team Leader on calculation of investigator payments accrual, budget base on finalized site agreement.

ü  Timely payment application and submission in the system per CRA’s request after receiving all the supporting documents from CRAs for sites.

Ÿ   SUSAR Reporting

ü  CTA to create distribution list and tracker for SUSAR reporting to sites by SIV

ü  Prepare the SUSAR report and submission letter within 2 working days upon receiving notification from PV.

ü  Draft and send Email notification to site and deliver paper document package to Sites (for submission to PI, GCP and EC)

3.         Contract, Payment and Reconciliation

Ÿ   Obtain Finance’s approval, signature of the legal representative and company seal for study related contracts within the timeline for 3^rd party vendors.

Ÿ   Timely payment application and submission per service confirmation and/or contract payment terms for 3^rd Party vendor via initiating workflow in Finance system.

4.         Logistic Support to Meeting

Ÿ   For Study Team meeting/Cross-functional meetings: Responsible for meeting invitation, conference room preparation, materials collection & presentation, and taking meeting minutes and follow up pending actions.

Ÿ   Investigator meeting: Coordinate with vendor for meeting venue, conference room setup, attendee’s transportation, accommodation and meal, advertisement design and printing etc.

5.         Study Communication Platform:

Ÿ   Set up the SharePoint online (SPOL) & MS Team at the initial phase of clinical trial and keep the information/materials up to date during course of the study.

Ÿ   Control the access of Email Group, study shared mailbox.

Ÿ   Maintain the study information on the Clinical trial registration platforms.

6.         CTMS Management at Study Level

Ÿ   Set up and maintain study workplace

Ÿ   Study/Country level milestone tracking

Ÿ   Report running and analysis

7.         Documents Development

Ÿ   Support formatting of Study/Country level Protocol, ICF

Ÿ   Coordinate the translation of Global Study Protocol/ICF with vendor

Ÿ   Contribute to the study management plan development such as TMF Plan, communication plan, etc.

8.         Study Newsletter Publication

Ÿ   Support STL edit and layout study newsletter to internal & external stakeholders on regular basis

9.         EDC/IxRS/Other System Accounts Management

Ÿ   Controller of account & access authorization

Ÿ   Account/access issue escalation

10.     Compile and maintain the related lists and logs

•              Study essential documents version control log

•              Study risk register and actions plan log

•              Study decision log and issue and action log

•              Study systems inventory log

•              Study vendor list

•              Vendor oversight plan list

•              Study specific training log

•              Study team member roster

•              Study Q & A

Ÿ   Others depending on study needs