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ARCQ

CTA/inhouse CRA

Via ARCQ | Anderlecht | Onbepaalde duur, Bepaalde duur, Voltijds

Providing smart staffing solutions to the life sciences, chemical and food industries is what we are good at.
Our exclusive focus gives us a sharper edge, and our commitment to quality implies we recruit only the best. 
We guarantee discretion, integrity and transparency.  
Moreover, we value and nurture a culture of enthusiasm, professionalism and commitment. 

CTA/inhouse CRA

Functieomschrijving

 

As a CTA / inhouse CRA you are responsible for setting up & maintaining clinical trial information in compliance with SOP’s and in close cooperation with CRA’s:

• Maintaining the quality compliance system 
• Handling of payments and maintaining of budget ClinOps list to facilitate re-invoicing.
• Offering administrative support for submission to Ethics Committees of clinical trial files & correspondence to Trial sites
• Offering administrative support to CRM and Head Clinical, Medical & Regulatory Affairs for feasibility evaluation of new development projects
• Arranging practical aspects of Monitors & Investigators meetings and others
• Gathering & preparing documentation for submission to MDEON by the Regulatory Department of “VISA” requests 
• Insuring permanence vis-à-vis customers (handling external & internal enquiries e.g. phone, e-mails) 
• Performs filing activities, eTMF completion and archives trials to Record Management Center
• Back-up Local Safety Officer, following tasks are covered as first-line backup :
• Handling of CIOMS (standardised individual safety reports) from Global Safety: daily screening, evaluation & selection, timely reporting to local Health Authorities, Ethical Committees and Investigators.
• Handling of Belgian safety mailbox 
• Handling & organising weekly tracking reporting of Individual Case Safety Report (ICSR) to Global Safety
• Identifying Data Monitoring Committee reports, Periodic SUSAR reports, DSURs eligible for reporting to Health Authorities and/or Ethical Committees and/or In-vestigators

Profiel

  • You have an administrative and/or scientific background
  • Experience within Clinical Research
  • You are flexible and pro-active
  • Fluent in Dutch, French and English
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Kenmerken

  • Functietype: Klinisch onderzoek
  • Sector: Chemie en Pharmacie
  • Anderlecht (standplaats)
  • Meer over het bedrijf

Vereisten

  • Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type)
  • Minstens 2 jaar ervaring
  • Engels, Frans, Nederlands

Aanbod

  • Onbepaalde duur
  • Bepaalde duur
  • Voltijds

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