Clinical Research Associate (CRA)
Clinical Research Associate (CRA)
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Job Description
As 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 qualification visits 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 biosciences. 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 organizational skills
- You work well independently as well as in a team
- You are constantly dotting the is and crossing the ts
- 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
Additional Information :
Do you want to be part of this
Were you already considering a big switch in your career Maybe this could be your next step.
We are looking forward to hearing from you! Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks. Still have questions Heidi can give you more details about the job. Send her an e-mail at
Please note that all applications are being handled via this platform not via mail.
Please note we cannot support a work permit procedure or relocation; Fluent Dutch is a must!
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
