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Clinical Research Associate I

Roles & Responsibilities

  • University degree or certification in a related allied health profession (e.g., nursing licensure)
  • Six months of clinical monitoring experience
  • Basic understanding of Regulatory Guidelines
  • Fluency in English and Hungarian

Requirements:

  • Independently manage and monitor clinical trial sites in line with ICH-GCP, applicable regulations, Fortrea SOPs, and study protocols (including initiation, routine monitoring, and close-out visits).
  • Ensure subject safety, protocol compliance, and data integrity through thorough source data verification, eCRF review, query management, and oversight of informed consent processes.
  • Maintain inspection-ready sites by ensuring completeness and accuracy of site regulatory documentation, eTMF, and investigational product accountability.
  • Collaborate closely with study teams to deliver milestones on time, support audit readiness, and address site issues proactively.

Job description

We are currently seeking CRA I to join our team in Hungary. This role will be home based.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Key responsibilities:

  • Independently manage and monitor clinical trial sites in line with ICH‑GCP, applicable regulations, Fortrea SOPs, and study protocols (including initiation, routine monitoring, and close‑out visits).

  • Ensure subject safety, protocol compliance, and data integrity through thorough source data verification, eCRF review, query management, and oversight of informed consent processes.

  • Maintain inspection‑ready sites by ensuring completeness and accuracy of site regulatory documentation, eTMF, and investigational product accountability.

  • Collaborate closely with study teams to deliver milestones on time, support audit readiness, and address site issues proactively.

Requirements

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)

  • Six (6) months of clinical monitoring experience

  • Basic understanding of Regulatory Guidelines

  • Ability to work within a project team

  • Good planning, organization, and problem-solving skills

  • Good computer skills with good working knowledge of a range of computer packages

  • Works efficiently and effectively in a matrix environment

  • Valid Driver's License

  • Fluency in English as well as in Hungarian

Learn more about our EEO & Accommodations request here.

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