Clinical Research Coordinator

4 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

Job Summary

The Clinical Research 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.

Key Responsibilities

  • Prepare Investigator Sites to conduct clinical trials by reviewing and approving 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 and collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
  • Escalate risks to site activation schedule to the Project Manager and communicate directly with study teams and external site staff to ensure tasks and priorities are aligned to the defined study timelines.
  • Collect, review, and file essential documents and ensure that the electronic Trial Master File (eTMF) contains relevant regulatory documents for site activation and ongoing study management.
  • Collect and distribute documents from/to sites, produce meeting minutes from project meetings, and maintain the ADI log.
  • Assign documents for internal project-specific training and coordinate training reconciliation and documentation.
  • May assist with drafting study documents and study plans for clinical trials and act as the main point of contact for all site correspondences for non-protocol related issues.
  • Assist sites with local ethics submissions and assist internal and external teams with access to study-specific systems.
  • Assist with initiating and maintaining study files, assembling and shipping the Investigator's Study File, and preparing shipments of study supplies to clinical sites when applicable.
  • Maintain project timeline dates, enrolment tracking tools, and study material inventory.
  • Participate in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.

About Innovaderm

Innovaderm 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 offer a stimulating work environment and attractive advancement opportunities.

Requirements

  • Bachelor's degree in a field relevant to clinical research or equivalent experience.
  • Specialized graduate diploma in drug development is an asset.
  • Experience in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry is an asset.
  • Excellent oral and written skills in English, French is an asset.
  • Excellent knowledge and competency in Word, Excel, and Power Point.
  • Ability to prioritize different assignments and work under pressure.
  • Attention to detail and meet timelines.
  • Quick learner, good adaptability, and versatile.
  • Strong organizational, communication, problem-solving, and multi-tasking skills.

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