We are currently working with a CRO partner of ours specializing in oncology studies and is seeking a Clinical Research Associate II to join their team in Spain. The position will form part of the clinical operations team and you'll be working closely with the team in Spain. The CRO specializes in Phase I-III oncology studies both in adults and paediatrics and are looking for a CRA II with minimum 2-3 years experience working in oncology to join their team.
*Responsibilities:* * Perform initiation visits to train and instruct site staff on the study specific requirements * Assist in site activation * Perform Monitoring visits to: * Verify that source data and study database are accurate, complete and maintained properly * Verify subject eligibility * Verify protocol compliance, including safety reporting and drug handling * Verify all study files are maintained and up to date * Support site staff in preparation for study specific site audits and inspections * Perform Close-out visits * Perform Pre-study visits, if delegated by SSU * Perform centralized and risk based monitoring activities * Act as the main line of communication between the study PM/LCRA and the site staff * Maintain study related trackers * Prepare site visit reports * Liaise with site staff to achieve patient recruitment targets * Contribute to the development of study specific documents * Support the study start-up team in preparation of the submission packages and collection of site documents, if delegated by SSU * Actively support site management staff learning & development within the company
*Qualifications:* * Life science, healthcare, medicine and/or related degree * Minimum 2 -3 year of CRA experience * Minimum 2-3 years of experience in drug development and/or clinical research * Good knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements * Good understanding of site management and monitoring * The ability to perform site visits in an effective way and according to high quality standards*Skills:* *
Strong written and verbal communication skills including good command of Spanish and English language * Representative, outgoing and client focused * Ability to work in a fast-paced challenging environment of a growing company * Administrative excellence with attention to detail and accuracy * Proficiency with various computer applications such as Word, Excel, and PowerPoint required * Strong organizational skills