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Clinical Research Consultant (CRC) - Belgium  

Company managed [?] Still accepting applications

Posted on : 10 November 2016

Project Description

Tasks:

Site Management
 
  • assume on-site monitoring duties and quality audits as needed 
  • oversee investigator recruitment, qualification and selection 
  • coordinate inventory and shipment of investigational products, clinical supplies and documents 
  • overlook patient enrollment and identify/outline patient recruitment strategies 
  • assure timely reporting of AEs/SAEs 
  • report appropriately Protocol Violations/Deviations
  • assure compliance with ICH and GCP guidelines , CFR and State regulations, Sponsor and company SOPs

Data Handling

  • perform source document verification according to contractual requirements 
  • assure timely completion and submission of CRFs according to Clinical Monitoring Plan and/or Data Managing Plan 
  • assure timely and accurate completion of Data Clarification Forms

Reporting and Tracking

  • complete and submit visit trip reports  
  • maintain awareness of key study performance indicators  
  • update study and patient status information and serve as resource 
  •  track investigator payments
  • document and track the resolution of all outstanding site-specific protocol-related issues from visit to visit

Regulatory Submissions and Documentation

  • perform or assist with submission of clinical trial dossiers and documents to Competent Authorities  (CA) and Ethics Commitees (EC) 
  • understand the EC/CA submission process in Belgium, The Netherlands and France 
  • maintain current regulatory documentation

Communication

  • maintain timely and effective communication among team members and site staff  
  • assure timely and detailed feedback to sponsor  
  • organize and present on project and investigator meetings

Profile
  • excellent in social and interpersonal contacts 
  • able to handle multiple tasks to meet deadlines 
  • motivating people (coaching, counseling, mentoring) 
  • customer-oriented, enthousiastic, dynamic 
  • willing to travel 

Education, knowledge and experience
  • Msc Biomedical Sciences, Msc (Para) Medical Sciences, or equivalent by experience  
  • minimum 1-2 year of experience in a similar function and/or in a CRO,in the pharmaceutical/medical device, in the biotechnology sectorexcellent in Dutch, French and English (spoken as well as written)
  • experience in Microsoft

Our offer
We offer you a challenging job with an interesting salary and extralegal benefits within a  pleasant work atmosphere and on a location without traffic jams. Possibility of development of your personal skills via courses.