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Clinical Research Associate Bucharest Romania,  

PSI (company)

Posted on : 05 April 2017

Project Description

  • We are currently looking for a knowledgeable, entrepreneurial and innovative person to join our Clinical Operations team.
  • If you are ready to work with full-scale complex trials in multiple therapeutic areas, ensure high quality standards of assigned projects and effective site performance, provide us with your expertise and guidance, and be involved in something new, outstanding and challenging, this job opportunity is perfect for you!

Clinical Research Associate II
The scope of responsibilities will include:
  • Preparation, conduct, and reporting of site selection, initiation, routine and closeout monitoring visits 
  • Site management, general administration of projects in Romania 
  • 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 of sites and teams 
  • Preparation for and attendance at company s audits; implementation of corrective actions 
  • Support to Regulatory Affairs in procurement of site regulatory documents 
  • Facilitation of site budgets and contract negotiations 
  • Maintenance of study-specific documentation and automated tracking systems 
  • Participation in feasibility research 

  • University degree in Pharmacy/Life Sciences, MD , RN or an equivalent combination of education, training and experience 
  • Monitoring experience in Romania and knowledge of the local clinical research environment 
  • Experience in regulatory submissions, contract negotiations, and feasibility assessment is preferable 
  • Fluent 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 
  • Ability to travel intensively; valid driver s license 
  • Demonstrated computer skills (MS Office applications) 



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