Clinical Trials Assistant - FSP

Work arrangement: 2-3 times a week at the office/ 2-3 times a week working from home

This role requires to come into office in Macquarie Park, Sydney.

Clinical trial related general tasks as required throughout the trial life cycle

◼ Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments
◼ Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online
◼ Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required
◼ Coordinate clinical trial related document translation process
◼ Support trial related documents verification
◼ Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc.
◼ Support CTM for the site ISF archival, if locally required to use external archiving vendor
◼ Support RA/EC submission e.g., CTR relevant as applicable
◼ Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical)
◼ Coordinate/Support investigational drug, clinical supplies, equipment preparation, maintenance e.g., calibration, and distribution/return to/from sites if applicable
◼ Support access request and maintenance for trial related systems of external vendors, if applicable
◼ Support activities for Audits, Inspections and CAPAs, if any support required
◼ Support arrangement and administrations for clinical trial related meetings e.g., Investigators meeting, if required the local OPU’s arrangement
◼ Take study team meeting minutes and subsequent distribution to relevant stakeholders
◼ Support regulatory/ethics reporting and internal tracking (e.g., Medsafe for New Zealand, CTN for Australia, Annual Ethics reporting for AU/NZ)
◼ Support trial/trial country related tracker maintenance and update
◼ Support label review process handling (for AU/NZ)
◼ OPU’s PSPV query mailbox back-up maintenance, for paper SAE reporting trials, as applicable

Clinical trial system related roles and tasks as required throughout the trial life cycle

◼ Act as Payment Manager to handle trial related payment process via Veeva Clinical including Investigator fee set up, payment report generation, PO creation (if applicable) & approval, IVT approval and if required relevant communication to CRO, Sites, GBS etc., as applicable
◼ Act as (back-up) Investigator Database Manager (IDM) to manage sites/investigators/site staffs’ information update into Veeva Clinical by adhering global/local regulatory requirements (e.g., Sending Global Privacy Notice Notification mail to site staffs, Filing of Acknowledgement from site staffs, Consent status check, Maintenance of relevant local tracker (e.g., PIPA tracker) etc.), maintain investigators’ quality included in the quality report for IDM., if locally applicable

General activities

◼ Coordinate organization and arrangement of CDO meetings/gathering/workshop related activities