GCO Associate I - FSP

Country & Site Operational Support

• 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.

Site Activation Support

• 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.

Site Contracting Support

• 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.

Education

• BS/BA or bachelor’s degree in life sciences or a related discipline is an asset.

Experience

• 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.