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Clinical Research Associate - Italy  

PSI (company)


Posted on : 20 February 2017

Project Description

Clinical Research Associate
If you are keen to work with full-scale complex trials in multiple therapeutic areas, provide us with your expertise and guidance, and be involved in something new, outstanding and challenging, come to our company and start your exciting professional journey with us!

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 Italy 
  • 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 team 
  • 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 automated tracking systems 

  • University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience 
  • Significant hands-on industry experience at a similar position, with full scope of monitoring responsibilities within Phase II/III Clinical Trials 
  • 1+ year independent monitoring experience in Italy 
  • CRA Certification 
  • Experience with Gastrointestinal indications preferably 
  • Fluent Italian 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)