Gco Associate I - Fsp

• Execute operational tasks across start-up, conduct and close-out phases
• Maintain and update trackers, timelines, or task status to support visibility of progress and risks
• Assist with follow-up on outstanding country or site deliverables and escalate gaps or delays to responsible leads as required
• Could support coordination with local vendors and CROs by tracking deliverables and ensuring required documentation is received and filed
• Undertake periodic review of study and site files for completeness and assist with reconciliation activities
• Maintain site-facing communications, as applicable, to complete assigned work activities
• Demonstrate a proactive approach to ongoing improvement by consistently seeking opportunities to enhance processes and optimise workflows
• Interactions with sites for collection of documentation needed for Institutional Review Board (IRB), Local Ethics Committee (LEC), Regulatory Authority (RA) submission and Investigator Initiation Packages (IIP) Updates preparation as per country requirements
• Responsible for preparation of Institutional Review Board (IRB)/Local Ethics Committee (LEC) clinical trial applications by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps
• Submission to local Regulatory Agency where required
• Responsible for preparation of Update to Investigator Initiation Packages (IIP) and essential documents by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps
• Support filing of documents in PTMF, eISF, and document exchange portals, ensuring completeness and correct placement
• Verify training, financial disclosure, and other required documentation in systems and upload documents received from sites, as applicable
• Maintain site-facing communications, as applicable, to complete assigned work activities
• Provide operational support to site contracting activities, including, but not limited to, site contract and budget preparation, site-facing negotiation, status tracking, and the coordination of workflows required for site contract finalization, execution and filing
• Maintain site-facing communications from document preparation through the execution and filing of site contracts
• Responsible for maintaining accuracy and completeness of site contracting systems and related trackers (as applicable) for assigned work

• BS/BA or bachelor's degree in life sciences or a related discipline is an asset
• 2-5 years of relevant experience in clinical trial support, site activation, or clinical operations (pharmaceutical company or CRO preferred)
• Exposure to country or site-level clinical trial operations and supporting documentation workflows
• Experience supporting contracting, regulatory, or vendor-related documentation processes is an advantage

Experience supporting contracting, regulatory, or vendor-related documentation processes is an advantage