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Clinical Research Associate

  • Location: Croatia
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 29 days ago

  • Sector: Clinical Operations
  • Contact: Megan Hall
  • Start Date: 01/09/2022
  • Expiry Date: 11 August 2022
  • Job Ref: JN -072022-472015

In this position you will:

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits)
  • Work with sites to adapt, drive, and track subject recruitment plan
  • Administer protocol and related study training to assigned sites
  • Evaluate the quality and integrity of study site practices
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
  • Create documentation for site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
  • Collaborate and liaise with study team members for project execution support as appropriate

Qualifications:

  • Degree in scientific discipline or health care
  • At least 1,5 years of independent on-site monitoring experience
  • Good knowledge of applicable clinical research regulatory requirements
  • Written and verbal communication skills including good command of English language

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