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ARCQ

CTA/inhouse CRA

Via ARCQ

Staat 16 dagen op Jobat.be

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
Brussel

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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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