Senior Project Coordinator

2 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

Job Summary

We are seeking a highly skilled and experienced Senior Project Coordinator to join our team at Innovaderm Research. In this role, you will be responsible for providing administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle.

Key Responsibilities

  • Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
  • Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
  • Communicate with clinical sites during site start-up and provide guidance on project-related activities.
  • Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
  • Escalate to the Project Manager any risks to site activation schedules.
  • Communicate directly with the study teams and external site staff to ensure tasks and priorities are aligned to the defined study timelines.
  • Collect, review, and file essential documents from sites.
  • Ensure that the electronic Trial Master File (eTMF) contains relevant regulatory documents for site activation and ongoing study management.
  • Collect and distribute documents from and to sites.
  • Produce meeting minutes from project meetings and maintain accurate records.
  • Assign documents for internal project-specific training and coordinate training reconciliation and documentation.
  • May assist with drafting of study documents and study plans for clinical trials.
  • Act as the main point of contact for all site correspondences for non-protocol related issues.
  • Assist sites with local ethics submissions and ensure compliance with relevant regulations.
  • Assist internal and external teams with access to study-specific systems and maintain project timelines.

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