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Clinical Research Associate II - Poland  

PSI (company)


Posted on : 05 April 2017

Project Description

  • A knowledgeable, entrepreneurial and innovative Clinical Research Associate II to join our Clinical Operations teams.
  • 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!

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 Poland 
  • 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 and delivering of presentations at Investigator’s Meetings 
  • 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 

  • University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience 
  • At least 2 years of independent on-site monitoring experience in active studies in the country of application and knowledge of the local clinical research environment 
  • Experience in monitoring Inflammatory bowel diseases or Multiple Sclerosis studies 
  • Strong working knowledge of ICH GCP Guidelines 
  • At least B2 level in English; C2 level in the local language 
  • 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