Clinical Research Associate II – Regionalized Galicia - Maternity Leave Cover - Oncology - Prostate and Lung

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.