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Clinical Trials Specialist Opportunity

2 tygodni temu

Katowice, Silesia, Polska Parexel International Pełny etat

Parexel FSP is a global leader in Contract Research Organizations (CROs), committed to delivering high-quality clinical research services. Our team's dedication and commitment to excellence have earned us 11 consecutive Leadership Awards.

We are seeking a skilled Clinical Research Associate in southern Poland (Krakow/Katowice) to strengthen our clinical operations team. This role offers the flexibility to work from home and maintain a healthy work-life balance with reduced travel and workload.

As a Clinical Research Associate, you will be responsible for setting up and overseeing studies, completing status reports, and maintaining documentation. You will participate in submitting protocols, consent documents, and assist in preparing regulatory submissions as requested.

This opportunity allows you to collaborate with a top pharmaceutical company on oncology studies that deliver significant impact. The ideal candidate will have:

Key Responsibilities:

  • Setting up and overseeing studies, ensuring compliance with regulatory requirements.
  • Completing status reports and maintaining study documentation.
  • Participating in protocol submissions, consent document review, and regulatory submission preparation.

Requirements:

  • Bachelor's degree in biological science, pharmacy, or a related health discipline.
  • Minimum 2 years of active independent field monitoring experience, including 1 year in oncology.
  • Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
  • Ability to perform all clinical monitoring activities independently.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Experience working in a self-driven capacity with minimal oversight.
  • A client-focused approach to work and flexible attitude towards assignments/new learning.
  • Ability to manage multiple tasks, evaluate unpredictable scenarios, and achieve project deadlines.
  • Honest and ethical work approach promoting life-changing treatments for patients.
  • Understanding of ICH GCP Compliance.
  • Excellent time management and social skills.
  • Motivated individual with attention to detail.
  • Travel requirement: approximately 65-75% of working time.