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Clinical Research Associate I/II

PSI CRO

Prague, Czech Republic

If you are keen to work with full-scale complex trials in multiple therapeutic areas, join PSI and start your professional journey with us.

The scope of responsibilities will include:

  • Conduct and reporting of monitoring visits
  • Site management, general administration of projects
  • Ensuring the integrity of clinical data in adherence to all applicable regulatory guidelines, company’s SOPs and project-specific operating procedures
  • Contact for clinical investigators, vendors and support services in regard to study progress
  • Effective communication within cross-functional teams
  • Project-specific training on sites
  • Preparation for and attendance at company’s audits; implementation of corrective actions
  • Support to Regulatory Affairs in procurement of site regulatory documents
  • Maintenance of study-specific documentation and automated tracking systems
  • Participation in feasibility research

The ideal candidate will have:

  • MD, University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training, and experience
  • Independent monitoring experience in the Czech Republic and knowledge of the local clinical research environment
  • Experience in Oncology trials is a plus
  • Strong working knowledge of ICH GCP Guidelines
  • At least B2 level in English; C2 level in Czech
  • Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
  • Attention to detail, organizational and time-management skills
  • Demonstrated ability to multitask and work proactively in a fast-paced environment
  • Good problem-solving abilities, flexibility
  • Valid driver’s license and ability to travel
  • Proficiency in MS Office applications

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