CRA II - early phase

Location
Belgium, Mechelen, Antwerp
Salary
Negotiable
Posted
07 Jun 2021
Closes
21 Jun 2021
Ref
YVAN0013
Contact
Yana Vandenberghe
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

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.

Qualifications
  • 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

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