In France, our sponsor dedicated
team continues its expansion, and we have opened a new job as CRA I
or CRA II
. THE JOB
Assigned to a Global TOP 5pharmaceutical company, t his is a permanent position, office based in Paris. Therapeutic areas includeOncology, Diabetes, Cardio and Rare Diseases.
We don´t hide you will work in complex and demanding ph I-III studies, but we know that the scientific challenge and seeing patients feeling better with these new treatments is what will keep you hooked to this team.
At Covance we trust our CRAs and so we will give you autonomy to organize your work. In turn, we expect you to go beyond the typical CRA role and really be an expert of your protocol and to own your sites .
- Your focus will be direct site management and we expect you to influence site performance
- It is key you create and nurture a collaborative relationship with sites in order to efficiently solve issues and questions with systems, documentation, filing or building audit-ready habits.
Master´s degree with strong emphasis in science and/or biology
Extensive knowledge of:
- Drug development process and client needs.
- ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Site Management Monitoring experience in France: minimum 1 year monitoring international ph I-III clinical studies at biopharmaceutical or CRO companies.
Proven track record of pre-study, initiation, routine monitoring and closeout visits.
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
Clinical Trial Monitoring in French and English