Senior Project Coordinator

4 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

Job Summary

The Senior Project Coordinator will work closely with Project Managers, Clinical Trial Managers, and Site Selection Team to provide administrative and coordinating support for site activation activities and other site level deliverables throughout the clinical trial lifecycle. As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets, and the quality of deliverables meet internal and external customer expectations.

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 first pass 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.
  • Serve as in-house contact to support CRAs when traveling.
  • Review and reconcile investigators site and vendor payments.
  • Assist with project tracking activities and status reports preparation.
  • Participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.
  • May support Health Authority inspection and pre-inspection activities.
  • May support audit preparation & Corrective Action/Preventative Action preparation for project related issues.
  • May perform project management duties on designated trials.
  • May mentor junior Project Coordinators and assist with onboarding activities.
  • May assist with process improvement and creation of training material within the Site Activation and Project Coordination department.

About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. Our organization has a solid reputation for the quality of its research and services exceeding the expectations of its clients. We continue to grow and expand in North America and Europe.

What We Offer

  • Flexible work schedule.
  • Permanent full-time position.
  • Vacation, PPK, health allowance.
  • Home-based position with teleworking allowance.
  • Ongoing learning and development.

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