01 nov
|
Fortrea
|
Madrid
Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Galicia.
¿No sabe con seguridad qué habilidades necesitará para esta posibilidad? Simplemente lea la descripción completa a continuación para obtener una idea clara de los requisitos del candidato.
Responsibilities
- Clinical site monitoring: conducts routine, pre-study, initiation, and close-out visits, ensuring full compliance with project plans.
- Site and patient protection: ensures informed consent, protocol adherence, and regulatory compliance to safeguard study participants.
- Data quality oversight: performs source document verification, CRF review, and manages data queries to ensure accuracy and completeness.
- Operational site management: prepares trip reports, ensures audit readiness, manages study files, coordinates with vendors, and uses resources efficiently.
- Safety reporting: tracks and follows up on Serious Adverse Events (SAEs), supporting report and narrative preparation.
- Extended support activities: feasibility assessments, QC visits, EC submissions, budget support, training/mentoring of new staff, and local project coordination.
- Cross-functional communication & logistics: liaises with internal teams, manages study materials, and travels as required.
Qualifications (Minimum Required)
- University Degree in Scientific / Medical Field
- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in Spain
- Fluent in Spanish and in English, both written and verbal.
Experience (Minimum Required)
- Minimum 2 years of experience as independent monitor, working specifically within oncology: Prostate and Bladder cancer.
- Basic understanding of Regulatory Guidelines.
- Ability to work within a project team.
- Good planning, organization, and problem-solving skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Valid Driver's License
Learn more about our EEO & Accommodations request here.
At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. xghoner Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.
📌 Clinical Research Associate II – Regionalized Galicia (Madrid)
🏢 Fortrea
📍 Madrid