Regulatory Project Coordinator

11 hours ago


Fatih, Istanbul, Turkey IQVIA Argentina Full time
About the Role

We are seeking a highly skilled Regulatory Project Coordinator to join our team at IQVIA Argentina. As a key member of our clinical operations group, you will play a critical role in ensuring the success of our investigative sites.

  1. Develop and maintain relationships with investigative sites to ensure successful collaboration.

  2. Coordinate Regulatory Start-up and Maintenance activities according to applicable regulations and SOPs/WIs.

  3. Distribute completed documents to sites and internal project team members.

  4. Prepare site regulatory documents, reviewing for completeness and accuracy.

  5. Negotiate site contracts and budgets with sites.

  6. Maintain accurate internal systems, databases, and tracking tools with project-specific information.

  7. Provide feedback to management on site performance metrics.

  8. Establish and agree on project planning and timelines. Implement contingency plans as needed.

  9. Inform team members of completed regulatory and contractual documents for individual sites.

  10. Track and follow up on document progress, approvals, and executions, including contracts, regulatory, ethics, ICF, and IP release documents, in line with project timelines.

  11. Provide local expertise to RSU leads and Project teams during project planning.

  12. Perform quality control on documents provided by sites.

  13. Have direct contact with Sponsors on specific initiatives.

  14. Perform Site Selection Visits if a trained monitor.

  15. Participate in feasibility and/or site identification activities.



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