Clinical Trial Site Coordinator

3 tygodni temu

Warszawa, Mazovia, Polska Milestone One Pełny etat

As a Clinical Trial Site Coordinator at Milestone One, you will play a crucial role in supporting trial sites in all related activities according to ICH-GCP and protocol requirements.

Key responsibilities include:

  • Act as the primary point of contact between the Sponsor or CRO and the site.
  • Ensure timely responses to feasibility questions.
  • Coordinate scheduling and preparation for monitoring visits.
  • Be present and available to respond to monitors during all types of monitoring visits.
  • Track patient enrollment and support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
  • Maintain study-specific and general tracking of documents at the site level.
  • Accurately and timely enter data into study-specific EDC systems and resolve data clarification queries.
  • Timely report and follow up on Reportable Adverse Events and Protocol Deviations.
  • Properly handle, account for, and reconcile investigational products and clinical supplies.
  • Collect, handle, and maintain all site-specific regulatory documents as needed.
  • Facilitate and support contract and budget negotiations at the site level.
  • Support Investigator and Site payments and processes as needed.
  • Schedule and/or perform study procedures according to study requirements and delegation of responsibilities.
  • Prepare for and participate in onsite study audits or regulatory agency inspections.

Requirements for the position include:

  • College or university degree in Life Science, preferably in pharmacy, nursing, or lab analytics.
  • Prior experience in coordinating clinical trials on site.
  • Ability to work in a fast-paced environment with short timelines and multiple tasks to complete simultaneously.
  • Ability to effectively communicate in stressful situations and demonstrate problem-solving skills.
  • Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.

If you are looking for a challenging role within a dynamic company that focuses on its people, Milestone One may be the right fit for you.

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