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1. 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
2. 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
3. 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
4. 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.
5. 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.
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