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Clinical Research Consultant (CRC) Hoegaarden Belgium,  


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 science)" rel="nofollow">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 science)" rel="nofollow">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
  • 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

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. 

Locations

Hoegaarden, Flemish Brabant, Belgium

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