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Rho

Experience, Rho. A global full-service CRO.

Freelance Regional Clinical Trial Coordinator

GeneralGeneralContractRemoteSeniorTeam 501-1,000Since 1984H1B SponsorCompany SiteLinkedIn

Location

Poland

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud PlatformVault

Job Description

Freelance Regional Clinical Trial Coordinator

Rho

• 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

Job 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

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