Clinical Research Associate II/ Senior CRA - Spain
A global clinical research organisation is presently looking for a Senior Clinical Research Associate (CRA). The company provides Phases I-IV clinical development services to the biotechnology, pharmaceutical and medical devices. Their Spanish office is looking for someone with exceptional experience who can help contribute accelerate the global development of safe and effective medical therapies.
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Verification that the investigator is enrolling only eligible subjects
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Skills and Requirements
- Minimum of a bachelor's degree; Health or life science related field preferred;
- 1-1.5 years' work experience as a CRA;
- Oncology monitoring experience would be an advantage;
- Familiarity with Microsoft® Office;
- Strong communication and presentation skills a plus; and
- Fluent Spanish and English-speaking skills.
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 contact Valeria Cardo at 0203 854 0674 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.