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Clinical Research Associate II – Regionalized Galicia - Maternity Leave Cover

Fortrea

Madrid · es 1d ago

Descripción del puesto

Fortrea's FSP team is currently seeking two CRA II professionals to join the team in Galicia. Summary of 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 .

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