A global contract research organisation has an exciting job opening for a SCRA with solid monitoring experience to be home based in Barcelona or close to Barcelona. The company specialises in research into pharmaceuticals, healthcare and nutrition and offer flexible conditions and excellent career development opportunities.
- Monitor 50 % of the time, and 50 % will have some coordination duties (contract negotiation, support in study oversight -e.g reading and follow up of weekly news, issue follow up, pre-review of monitoring visit reports, support of CRA productivity...)
- A contact partner for the respective study teams in Head office,
- Contact partner or directly involved with EC submissions.
- Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
Skills and Requirements:
- Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Excellent understanding of Serious Adverse Event reporting
- Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organisation of meetings and other tasks.
- Negotiation of study budgets with potential investigators and collaboration with the legal department with statements of agreements
- Fluency in both English and Spanish
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 CVon 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.