BrightOwl Loader Loading

Senior 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 keen to work with full-scale complex trials in multiple therapeutic areas, provide us with your expertise and guidance in the region, ensure smooth running of all aspects of the clinical project, 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 projects in Romania 
  • Providing support with site contractual start-up process 
  • Coordination of site regulatory documents collection 
  • Management of investigator site payments 
  • Monitoring trial progress and ensuring that the project timelines and patient enrollment schedules are met 
  • Effective and open communication with investigational sites, project and support staff 
  • Back up communication point for clients and vendors 
  • Delivering onsite training of investigators and staff 
  • Preparation and delivering of presentations at Investigator s Meetings 
  • Project-specific and field training of Clinical Operations and support staff 
  • Compliance monitoring, participation in quality control activities 
  • Review of draft monitoring reports 
  • Coordination of safety information flow 
  • Preparation for and attendance at company s audits; follow-up and resolution of audit findings 
  • Maintenance of appropriate documentation regarding clinical site management 
  • Participation in feasibility research 
  • 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 
  • Participation in clinical projects in the capacity of a SrCRA 
  • Experience in regulatory submissions, contract negotiations, site management and feasibility assessment 
  • 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 
  • Valid driver s license and ability to travel 
  • Demonstrated computer skills (MS Office applications) 



Find a Job Find Candidates

Similar Jobs

More jobs from PSI

Other jobs in Romania

Other jobs in Bucharest

Other similar job in Bucharest

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like