GCO Associate I

This is a fully remote position, open to applicants in Spain, +1 more state.

📋 Description

• Carry out operational responsibilities throughout the phases of clinical trial initiation, execution, and completion.

• Keep trackers, timelines, and task statuses up to date to enhance visibility of progress and potential risks.

• Follow up on pending deliverables from countries or sites and escalate any gaps or delays as necessary.

• Monitor local vendor and CRO deliverables, ensuring that required documentation is collected and properly organized.

• Assess study and site files for completeness and assist in reconciliation efforts.

• Manage site-facing communications to fulfill assigned tasks.

• Identify and propose opportunities for process improvements and workflow optimization.

• Gather documentation for IRB, LEC, RA submissions, and Investigator Initiation Packages.

• Prepare clinical trial applications for IRB/LEC by pre-filling documents and sourcing necessary records.

• Submit materials to local Regulatory Agencies as needed.

• Update Investigator Initiation Packages and essential documents accordingly.

• Organize documents within PTMF, eISF, and document exchange portals.

• Confirm training, financial disclosure, and other necessary documentation, then upload site documents.

• Assist with site contracting, which includes contract and budget preparation, site-facing negotiations, status monitoring, workflow coordination, execution, and filing.

• Ensure the accuracy and completeness of site contracting systems and trackers.

⛳️ Requirements

• 2–5 years of relevant experience in clinical trial support, site activation, or clinical operations within a pharmaceutical company or CRO.

• Familiarity with country- or site-level clinical trial operations and documentation workflows.

• Experience in supporting contracting, regulatory, or vendor-related documentation processes is a plus.

• Strong written and verbal communication skills.

• Ability to work efficiently in a matrix environment while following directions and collaborating across functions.

• Proficiency in English and the applicable local language for the country.

• A BS/BA or bachelor's degree in life sciences or a related field is advantageous.

• Proficiency in additional languages is considered an asset.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan including Health, Dental & Vision coverage.

• Life Assurance.

• A supportive work environment.

• A culture that emphasizes teamwork and collaboration.

• Colleagues who inspire and tackle challenges together.

• Access to innovative technology.

• Exceptional training opportunities.

• Flexible home-based work from a home office.