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    4 tygodni temu

    Warszawa, Mazovia, Polska PSI CRO Pełny etat

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Clinical Research Associate II

1 miesiąc temu

Warszawa, Mazovia, Polska Pharmiweb Pełny etat
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team. As a CRA II, you will be responsible for managing clinical trials according to the protocol and ICH GCP, standard operation procedures, and monitoring plan.

Key Responsibilities
  • Manage clinical trials according to the protocol and ICH GCP, standard operation procedures, and monitoring plan.
  • Knowledge and understanding of the protocol and CRF content.
  • Keep contact with the Investigator.
  • Support sites with all issues concerning study.
  • Provide information to investigators about protocol principles, study timelines, enrolment expectations, and proposed fee.
  • Prepare and perform Initiation Visit and Monitoring Visit according to the GCP and monitoring plan.
  • Prepare Institution and Investigator fees documentation.
Requirements
  • A life science/healthcare-related degree or equivalent work experience.
  • Minimum 1 year of independent monitoring experience (mandatory).
  • Solid understanding of clinical trial design, trial execution, and operations.
  • Knowledge of international standards (GCP/ICH), international (FDA, EMEA), and local regulations.
  • Expertise in communication, managing multiple priorities, and computer literacy.
  • Proven people management skills with demonstrated expertise in working in a team.
  • Fluency in English as well as Polish.
What We Offer
  • Competitive salary.
  • A range of additional benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning, and more.

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.