SCRA - Home based - Spain
An international contract research organisation (CRO) is recruiting for a Senior Clinical Research Associate (SCRA) to join their Spanish team. The company provides complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases and conducts studies which lead to marketing approval of significant medical advances. This is an exciting opportunity to work with a firm that has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfils all regulatory requirements. The position will be with the company's Spain team, but in a home-based capacity.
- Liaise between study site and the project team.
- Pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs.
- Mentoring to project specific staff. Prepare and deliver staff training sessions and conduct CRA training visits.
- Support the Project Manager.
- Assist in the day to day running of projects assigned.
- Liaise between the company and Sponsor representatives as required.
- Assist in the review of protocol, amendments, Informed Consent Forms.
- Assist in the co-ordination and development of study start up materials.
- Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.
- Perform clinical reviews of individual patient listings.
- Translate study documents.
- Participate in project administration e.g., photocopying, binder preparation, start-up pack preparation etc.
- Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
Skills and Requirements:
- Healthcare professional with at least 2 years of clinical experience, or Science Graduate.
- Oncology experience.
- At least 2 years of experience as a Clinical Research Associate with a sound track record in managing clinical trial sites.
- Demonstrated understanding of oncology study end points.
- Detailed knowledge of ICH-GCP.
- Demonstrated understanding of clinical databases.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 Sonia Buxeda-Mas at +44 203 078 9576 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.
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