Freelance Regional Clinical Trial Coordinator

Posted 1hrs ago

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Job Description

Freelance Regional Clinical Trial Coordinator at Rho, a global CRO, handling clinical trial documentation and stakeholder communication across Europe.

Responsibilities:

  • Supports in preparation of ISFs (Investigator Site Files).
  • Contact, communication and guidance to CRA and sites as instructed by Trial manager
  • Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness.
  • Upload Country and Site level documents in Veeva Vault in a timely manner.
  • Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis.
  • Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions
  • Facilitate the communication between stakeholders in regards to documentation management
  • Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed
  • Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures
  • Sponsor/ Rho team meetings preparation, drafting meeting minutes.
  • Maintains tracking information for Study activities.
  • Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry)
  • Supports CRA (Clinical Research Associate) in maintaining ISF at Site.
  • Support sites getting access to systems, as needed
  • Support Trial Manager sharing updates with sites
  • Support on audits and/or inspections

Requirements:

  • Experience in clinical trial coordination or related administrative roles.
  • English language
  • Computer literacy
  • Preferably university degree in position related field
  • Advanced knowledge of ICH-GCP guidelines
  • Excellent communication (including reading, verbal, and written in both local language and English) and organizational skills
  • Capabilities in managing multiple assignments and work independently