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Clinical Research Associate II Paris France,  

PSI (company)


Posted on : 17 January 2017

Project Description


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 France 
  • 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 

Qualifications:
  • 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 
  • Independent monitoring experience in France 
  • Experience in regulatory submissions, contract negotiations, site management and feasibility assessment 
  • Experience with Oncohematology indications 
  • Fluent French 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) 

We offer:
  • We are  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.
  • We provide high-quality employment, competitive salary, excellent working conditions and a personable supportive environment. 
  • It is a great chance to join the company that really cares for its people, and invests in their professional development and success.

Locations

FRANCE PARIS

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