Hartje

Clinical Research Associate (CRA) in Mechelen

At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business. SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to more than 90 000 colleagues worldwide, with 1650 employees in Belgium only. Our employees give 110% of themselves every day, divi

Beschrijving

As a clinical research associate you will be responsible for: 

  • Participating in the trial set up activities
  • Preparing, translating, reviewing, finalizing, tracking and filing study documents
  • Conducting site initiation visits, monitoring visits (on-site and remote, in accordance with the monitoring plan) and close-out visits at assigned clinical site(s) according to applicable regulations, SGS procedures and study specific documents.
  • Writing site visit reports
  • Verifying the IMP management process at site (storage, return, accountability…)
  • Managing trial sites
  • Overseeing overall integrity of the study, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol
  • Ensuring compliance of the trial conduct with the protocol and the applicable guidelines, regulations and SGS procedures

You will work in close collaboration with other CRAs and the Study Team to ensure that quality and milestones are achieved within the budget and you will maintain regular contacts with the sponsor, project team and investigator.


  • You have obtained a university degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or bio-sciences. An equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
  • You can work in a self-driven capacity, with a sense of urgency and limited need for oversight
  • You are fluent in both Dutch and English; knowledge of French is an asset
  • You are a strong communicator and have strong organisational skills
  • You work well independently as well as in a team
  • You are constantly dotting the i's and crossing the t's
  • you have a good knowledge of ICH GCP and European Directives 2001
  • You are accountable, helpful, dedicated and flexible
  • You are willing to travel, if necessary

Extra informatie

Status
Open
Opleidingsniveaus
HBO5
Plaats
Mechelen
Dienstverbanden
Fulltime (startersfunctie)
Gepubliceerd op
28-11-2024
Beroepsgroepen subcategorie
Administratief
Rijbewijs nodig?
Nee
Auto nodig?
Nee
Motivatiebrief verplicht?
Nee
Talen
Arabisch

Mechelen | Administratieve vacatures | Fulltime (startersfunctie) | HBO5

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