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Freelance Clinical Trial Site Coordinator

Freelance Clinical Trial Site Coordinator

PSI CROParis, Paris, France
Il y a 15 jours
Type de contrat
  • Temps plein
Description de poste
  • Act as the main line of communication between the Sponsor or CRO and the site.
  • Ensure response to feasibility questions are provided in due time.
  • Assist in scheduling and preparation for all types of monitoring visits at the medical institution / research center.
  • Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.
  • Track patient enrollment and actively 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.
  • Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.
  • Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.
  • Proper handling accountability and reconciliation of investigational products and clinical supplies.
  • Collect handle and maintain all sitespecific regulatory documents as needed.
  • Facilitate and support the contract and budget negotiations at the site level.
  • Support Investigator and Site payments and processes as needed.
  • Schedule and / or perform study procedures as per study requirements and delegation of responsibilities.
  • Prepare for and participate in onsite study audits or regulatory agency inspections.

    • Qualifications :

    • A university degree in Life Science preferably in pharmacy nursing or lab analytics.
    • Minimum of 2 years of experience in a clinical trial environment in the role of a Study Coordinator or similar function.
    • Full working proficiency in French & English
    • Ability to work in a fastpaced environment with short timelines and multiple tasks to be completed simultaneously.
    • Ability to effectively communicate in stressful situations and demonstrate the ability to problemsolve in an effective and efficient manner.
    • Valid Drivers License with the ability to travel as needed.
    • Flexibility in working hours may be required depending on the schedule of study procedures and / or patient visits.

      • Remote Work : Employment Type :

      Fulltime