GCO Associate I

Posted 3ds ago

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Job Description

GCO Associate supporting Parexel’s sponsor-dedicated clinical trials from home in Spain, Israel, or Poland. Managing site activation, regulatory documentation, and contracting workflows.

Responsibilities:

  • Execute operational tasks across clinical trial start-up, conduct, and close-out phases
  • Maintain and update trackers, timelines, and task statuses to support visibility of progress and risks
  • Follow up on outstanding country or site deliverables and escalate gaps or delays
  • Track local vendor and CRO deliverables and ensure required documentation is received and filed
  • Review study and site files for completeness and assist with reconciliation activities
  • Maintain site-facing communications to complete assigned activities
  • Identify opportunities to improve processes and optimize workflows
  • Collect documentation for IRB, LEC, RA submissions, and Investigator Initiation Packages
  • Prepare IRB/LEC clinical trial applications by pre-populating documents and locating required records
  • Submit materials to local Regulatory Agencies where required
  • Prepare updates to Investigator Initiation Packages and essential documents
  • File documents in PTMF, eISF, and document exchange portals
  • Verify training, financial disclosure, and other required documentation and upload site documents
  • Support site contracting, including contract and budget preparation, site-facing negotiation, status tracking, workflow coordination, execution, and filing
  • Maintain accurate and complete site contracting systems and trackers

Requirements:

  • 2–5 years of relevant experience in clinical trial support, site activation, or clinical operations in a pharmaceutical company or CRO
  • Exposure to country- or site-level clinical trial operations and documentation workflows
  • Experience supporting contracting, regulatory, or vendor-related documentation processes is an advantage
  • Effective written and verbal communication skills
  • Ability to work effectively in a matrix environment and follow direction while collaborating across functions
  • Fluency in English and the applicable local language by country
  • BS/BA or bachelor’s degree in life sciences or a related discipline is an asset
  • Additional languages are an asset

Benefits:

  • Premium salary
  • Attractive benefits
  • Medical care plan: Health, Dental & Vision
  • Life Assurance
  • Excellent work environment
  • Culture of teamwork and collaboration
  • People who motivate and face challenges together
  • Innovative technology
  • Excellent training
  • Home-based work from a home office base