Clinical Research Associate Ukraine

2 months, 1 week ago
Full-time
Mid Level
Operations
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001

Description

  • Monitor and manage study sites, including site selection, initiation, monitoring, and close-out visits.
  • Perform feasibility assessments and support study start-up activities.
  • Create, maintain, archive, and manage required study documentation and correspondence.
  • Ensure clinical trials are conducted in accordance with protocol, ICH-GCP, and other regulatory requirements.
  • Deliver protocol and study-related training to assigned sites.
  • Review regulatory documents for study sites and submissions.
  • Prepare clinical trial documents and maintain correspondence records.
  • Negotiate study budgets with potential investigators and sites.
  • Assist with study agreements and site contracting activities.

Requirements

  • University degree in a Life Science field.
  • Fluent English and local language skills.
  • Independent monitoring experience as a Clinical Research Associate.
  • In-depth therapeutic and protocol knowledge.
  • Strong knowledge of clinical research regulatory requirements, including GCP and ICH.
  • Excellent MS Office skills and experience with EDC and other clinical trial systems/platforms.
  • Strong attention to detail and time-management skills.
  • All CVs must be submitted in English language.

Benefits

  • Professional growth and career opportunities.
  • International team and working environment.
  • Annual performance-based bonus.
  • Personal accident and business trip insurance.
  • Additional health insurance.
  • Remote/home-based work arrangement with office and home-based setup in Ukraine.
  • Complimentary health and wellness benefits, including influenza vaccines.
  • Workplace establishment allowance for fully remote employees.
  • Team building activities, global meetings, and B active events.

Interested in this position?

Apply directly on the company website

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