Senior Project Coordinator

hace 4 días

Madrid, Madrid, España Innovaderm Research A tiempo completo

Job Summary

The Senior Project Coordinator will work closely with Project Managers, Clinical Trial Managers, Site Selection Team, and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site-level deliverables throughout the clinical trial lifecycle.

This role requires a strong understanding of clinical trial operations and the ability to work autonomously to ensure optimized site activation and maintenance.

Key Responsibilities

  • Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
  • Establish site activation timelines with selected sites and coordinate activities to meet planned activation timelines.
  • Communicate with clinical sites during site start-up.
  • Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
  • Escalate to the Project Manager risks to site activation schedule.
  • Communicate directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.
  • Collect, review, and file sites' essential documents.
  • Ensure essential documentation is complete and of good quality to successfully pass the first review for site activation.
  • Ensure that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
  • Collect and distribute documents from/to sites.
  • Produce meeting minutes from project meetings.
  • Maintain ADI log.
  • 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 a main point of contact for all site correspondences for non-protocol related issues.
  • Assist sites with local ethics submissions.
  • Assist internal and external teams with access to study-specific systems.
  • Assist with initiating and maintaining study files.
  • Assist with assembling and shipping the Investigator's Study File.
  • Maintain project timeline dates, enrolment tracking tools, and study material inventory.
  • Prepare shipments of study supplies to clinical sites, when applicable.
  • Assist with preparation of Investigators' Meeting.
  • Distribute study correspondence to sites.

Requirements

  • A minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
  • Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.
  • An interest in project administration and clinical research.
  • A desire to have an impact in a fast-growing company.

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