Covance Job - 30598895 | CareerArc
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Company: Covance
Location: Brussels, Belgium
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

We are currently looking for talented Clinical Research Associates to join our team in Belgium. You would be working within our ClinOps team.

You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

Responsibilities include:

  • All details of site management as prescribed in the project plans
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
  • Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
Education/Qualifications:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Experience:
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Excellent understanding of Serious Adverse Event (SAE) reporting
  • Ability to resolve project-related problems and prioritize workload for self and team
  • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).


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