该职位来源于猎聘
- TMF/eTMF Support: -Set up the eTMF system/ paper binder at the initial phase of the clinical trial. -Assist Study Team Leader (STL) in TMF/eTMF management including eTMF uploading, TMF archival at study/country/Site level*. -Perform technical check for TMF documents upon receipt*, ensuring the document format meet the SOP requirement. -Lead the TMF Quality Check (QC) activity by involving cross-functional team members
- Country/Site Support: -Submission Package -Support preparation of the RA/EC/HGR submission package under the guidance from PM. -Equipment and Others Supplies Support: -Responsible for non-drug supply of clinical sites, from order creation to shipment depending on study needs. -Prepare for supply receipt and distribute to CRA for site signature. -Coordinate equipment calibration with CRAs at the end of the study. -Finance Support -Obtain Finance's approval, signature of the legal representative and company seal for study related contracts within the timeline. -Support Study Team Leader on calculation of investigator payments accrual, budget base on finalized site agreement. -Timely payment application and submission in the system per CRA's request after receiving all the supporting documents from CRAs for sites. -SUSAR Reporting -CTA to create distribution list and tracker for SUSAR reporting to sites by SIV -Prepare the SUSAR report and submission letter within 2 working days upon receiving notification from PV. -Draft and send Email notification to site and deliver paper document package to Sites (for submission to PI, GCP and EC
- Contract, Payment and Reconciliation -Obtain Finance's approval, signature of the legal representative and company seal for study related contracts within the timeline for 3rd party vendors. -Timely payment application and submission per service confirmation and/or contract payment terms for 3rd Party vendor via initiating workflow in Finance system
- Logistic Support to Meeting -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. -Investigator meeting: Coordinate with vendor for meeting venue, conference room setup, attendee's transportation, accommodation and meal, advertisement design and printing etc.
- Study Communication Platform: -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. -Control the access of Email Group, study shared mailbox. -Maintain the study information on the Clinical trial registration platforms. Fresh Graduate