CRA II or Senior CRA - Home based or Office based

Senior CRA position available to work for an international pharmaceutical company and international environment across different therapeutics areas and phases II and III. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in France. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

• The role can be home based or office based in Paris area.
• Join a stable team of CRAs and benefit from outstanding training and development, both initially and throughout your career
• Join a company where people tend to stay for 6-10 years rather than 1-3!
• Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.
   

Responsibilities Include

As a CRA you will manage all aspects of study site monitoring according to SOPs, 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

• Life Science educational background
• Master in Clinical monitoring
• Fluent in both English and French

• At least 2 years of independent monitoring experience in international trials.
• Previous experience in monitoring Ophtalmology protocols