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Clinical Research Associate

PSI

Budapest, Hungary

If you are keen to work with full-scale complex trials in multiple therapeutic areas, provide us with your expertise and guidance in the region and be involved in something new, outstanding and challenging, this job opportunity is perfect for you!

PSI is recognized by a unique combination of team collaboration and independent work, global dimensions and individual approach. We provide a stable and secure workplace, while giving opportunities for innovative ways of doing things.

The scope of responsibilities will include:

  • Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
  • Site management, general administration of clinical research studies in Hungary
  • Contact for clinical investigators, vendors and support services in regard to study progress
  • Monitoring trial progress and ensuring that the project timelines are met
  • Facilitation of site budgets and contract negotiations
  • Effective and open communication within the project teams
  • Delivering onsite training of investigators and staff
  • Preparation for and attendance at company’s audits; resolution of audit findings
  • Support to Regulatory Affairs in procurement of site regulatory documents
  • Maintenance of appropriate documentation regarding clinical site management
  • Participation in feasibility research
  • Participation in query resolution
  • Maintenance of study-specific and corporate tracking systems at site level

Qualifications:

  • University degree in Life Sciences, Pharmacy or MD
  • 1-3 years of independent monitoring experience in Hungary and knowledge of the local clinical research environment
  • Experience in regulatory submissions, contract negotiations, site management and feasibility assessment
  • Experience with gastroenterology and infectious diseases is preferred
  • Fluent Hungarian and English, spoken and written
  • 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
  • Demonstrated computer skills (MS Office applications)

For more details and to apply for this job click here

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