UNBLINDED CLINICAL RESEARCH ASSOCIATE
- Experience Level
- Experienced (non-manager)
A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Would you like to work for one of the best known big pharma companies? Our sponsor is a global pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials.
We are currently looking for a talented Clinical Research Associate to join our unblinded team in the Paris area, France. You would be working within our Flexible Solutions department dedicated to one sponsor/client on pharmacy monitorings.
Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out, and maintenance of study files.
- All details 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 cooperation 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
University or college degree, or certification in a related allied health profession or life science from an appropriately accredited institution
- 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 have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).