Remote Clinical Start-Up Specialist - Poland

GRUPA NEUCA

Polska

Hybride

PLN 180 000 - 240 000

Plein temps

Il y a 42 heures
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Avantages offerts par ce poste

Remote work opportunities
Comprehensive benefits Cafeteria
Top Employer 2026 certificate
Pet-friendly benefits

Résumé du poste

GRUPA NEUCA is seeking a Clinical Research Associate II focused on Study Start-Up and Maintenance in Poland. You will act as the primary contact for clinical sites, ensuring regulatory readiness, and coordinating document flows across the study lifecycle.

The role requires strong knowledge of EU CTR/CTIS and Poland-specific requirements. Experience with interventional trials and start-up activities in multiple countries is valued.

Qualifications

  • Fluency in Polish and English, both written and spoken.
  • Strong organizational and coordination skills.
  • Experience acting as main contact with clinical sites.
  • Knowledge of EU CTR/CTIS processes and Poland regulations.
  • 3+ years in Poland Start-Up within CRO/sponsor settings.
  • Experience with interventional clinical trials.

Responsabilités

  • Coordinate sites and projects across study lifecycle, supporting initiation, compliance and regulatory docs.
  • Customize country-specific ICF for Poland.
  • Collect and QC documents for EU CTR Part II and Ethics submissions.
  • Prepare and QC regulatory green light packages.
  • Track in CTMS and file in eTMF.
  • Support site feasibility and local language outreach.
  • Assist in site contract and budget negotiations with Polish sites.
  • Collaborate with study teams to enable timely site activation.

Connaissances

Polish & English fluency
Project coordination
Client liaison
EU CTR/CTIS knowledge
Study Start-Up Poland
Interventional trials experience
Start-up abroad
Regulatory submissions

Description du poste

GRUPA NEUCA is seeking a Clinical Research Associate II focused on Study Start-Up and Maintenance in Poland. You will act as the primary contact for clinical sites, ensuring regulatory readiness, and coordinating document flows across the study lifecycle.

The role requires strong knowledge of EU CTR/CTIS and Poland-specific requirements. Experience with interventional trials and start-up activities in multiple countries is valued.

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