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 start-up 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 (33189)

Wat zoeken wij?

Relevant life science degree / medical / nursing background or equivalent
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

Challenging projects based on your interests and skills
Personal follow-up 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