Clinical Research Associate II – Regionalized Galicia - Maternity Leave Cover

• 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):

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• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements in Spain
• Fluent in Spanish and in English, both written and verbal.

• 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 .