Location: Paris, France
Closing Date: 27 Oct 16
Salary (£): Competitive
We are looking for 2 x Lead CRAs for audit activities for a new client based in Paris, looking for 4 to 5 years of experience; we can only consider candidates with CRO or pharma experience. The role will be based on the client site in Paris, and will also require weekly travel to Tunisia (for inspection preparation) for 2 and ½ days each week. This is for 4 months initially, but could be extended for longer.
We are always looking for talented clinical research professionals for Clinical Research Associate positions (CRA) in France. If you are already working in the clinical trial industry in site monitoring and study site management, we want to talk to you about your career development.
Covance is committed to providing a clinical research career with purpose in a culture that values achievement. At Covance there are opportunities to work in our Clinical Operations team in Early Clinical Development or in Phase II-IV studies or we have roles in CoSource where you can be outsourced and work as a part of sponsors clinical monitoring team.
Experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global trials. Whether you're ready to make a move or just interested in learning more, apply today and let's talk!
About the Job:
Clinical Research Associates manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
- All aspects of site management as prescribed in the project plans
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
- Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
- Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
- 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
- You must have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
Covance is one of the world's largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. Through our discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
We welcome your application and believe this decision may be the most rewarding career move you will ever make!
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