Our client is one of the largest CROs in the world, and they are looking to recruit a Senior CRA to be based in Budapest, Hungary. The company specialises in research into pharmaceuticals, healthcare and nutrition and offer flexible conditions and excellent career development opportunities. With this client, there are opportunities to work in their Clinical Operations team in Early Clinical Development or in Phase II-IV studies or undertake roles in CoSource where you can be outsourced and work as a part of sponsors clinical monitoring team.
Clinical Research Associates manage all aspects of study site monitoring according to company 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 company 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 company 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).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.