In France, our sponsor dedicated team continues its expansion, and we have MULTIPLE job opportunities for experienced Clinical Research Associate II and Senior Clinical Research Associates.

THE CRA II / SCRA JOB

• You will work sponsor dedicated for a prestigious Top 5 global Pharmaceutical company, mainly in Oncology , but also Vaccines, Infectious diseases, Cardiology and Neurology.

We have many jobs open. Our ideal location is the region of Paris, and depending on your seniority & expertise we could also consider:

• Toulouse/Bordeaux
• Lyon
• Brest

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.

WHAT MAKES THESE JOBS SPECIAL

• You will join a successful and stable project team: last year we almost doubled our team in France.
• We have a well-organized structure, robust processes in place and unambiguous communication (you will know who to ask, you will receive clear answers which will allow you to resolve fast) .
• Y our Line Manager has an open and communicative style and will support you according to your and client needs.
• For Senior CRAs there will be the opportunity to buddy new CRAs and mentor interns .

WILL YOU BE ABLE TO GROW?

Covance have a long standing and strong collaborative relationship with this sponsor in France. This enables our CRAs to have the best formal and informal development opportunities due to this trusted and transparent partnership between management teams.

Some examples of informal development opportunities that will enrich your CRA career:

• SME responsibilities : you may be selected to act as the team expert in special systems and initiatives such as eTMF, CTMs, Report completion...
• Internal trainer : this usually involves receiving international training that you will have to pass on to the French team

This adds to our on-going formal training events, internal CRA forums, on-going team meetings, study meetings, 1:1, co-monitoring, etc.

OTHER INFORMATION

This role is a full time and permanent position to be employed through Covance.
Education/Qualifications:
Required:

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.

Experience:
Site Management Monitoring experience in France: minimum 2 years monitoring international ph I-III clinical studies at biopharmaceutical or CRO companies.

Oncology monitoring is needed: 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