GCO Associate I - FSP
Remote · United Kingdom or Harrow, England, United Kingdom
Job Summary
GCO Associate I at Parexel providing country and site operational support across start-up, site activation, regulatory submissions, and site contracting. Responsibilities include maintaining trackers and timelines, following up on country/site deliverables, coordinating with local vendors/CROs, reviewing site files for completeness, assisting with Institutional Review Board (IRB)/Local Ethics Committee (LEC) and Regulatory Authority submission preparation, pre-populating Investigator Initiation Package (IIP) documents, supporting PTMF/eISF/document exchanges, and supporting site contracting workflows. Emphasis on ensuring documentation is complete, tracking progress and risks, and improving processes to optimize workflows. BS/BA in life sciences is an asset and 2-5 years of clinical operations/trial support experience is expected.
Required Qualifications
- 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
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