Clinical Research Associate - Brussels, België - Pauwels Consulting
Beschrijving
In het kortbrussel / bruxellesbediende, freelancer
40 uur per week
- Amandine JansenTalent Acquisition Lead Life Sciences
Clinical Research Associate:
- Pharma & Sciences
- Clinical Research
- Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH)
- Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule
- Participates in the startup process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, and organizing and presenting at investigator meetings.
- Prepares site visit reports and telephone contact reports
- Resolves site issues, including site recruitment challenges, and determines status for IP shipment
- Attends Investigator Meetings (IM) and study specific training meetings
- Participates in feasibility and/or site identification activities
- Prepares Regulatory and Ethics Committee submissions, ensures written approvals are obtained and distributed appropriately prior to Site Initiation
- Prepares and attends Assessment Visits
- Provides secondary review of CRFs
- Referentienummer
Wat zoeken wij?
- At least 3 years of clinical monitoring experience and/or relevant clinical trial experience
- Sound knowledge of GCP/ICH
- Fluency in French, Dutch and English is a must
- Willing to travel in Belgium, depending on project needs
Wat bieden we aan?
**- Challenging projects based on your interests and skills
- Personal followup and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
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