Senior CRA position available to work within 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 Spain. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!
- Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets (6 per month)
- The role can be home based or office based in Madrid.
- 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.
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. Responsibilities include:
- 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