31 oct
|
Fortrea
|
Madrid
Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Galicia.
ResponsibilitiesClinical 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 FieldThorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in SpainFluent 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 LicenseLearn 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. 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