About this role
Our FSO department in Portugal is looking for a CRA I / II to manage clinical studies principally in Oncology, Hematology and Immunology . Home based in Porto area.
Main 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 required:
• University Master's degree in healthcare or similar.
• Basic understanding of the clinical trial process and foundational knowledge of applicable regulatory guidelines.
• Fluency in both English and the local office language, in written and verbal communication.
Experience (Minimum Required): • Mandatory 1 year minimum of experience as CRA. • Understanding of Regulatory Guidelines. • Good computer skills with good working knowledge of a range of computer packages. By stepping into this role, you’ll join a highly collaborative, supportive, and growth‑oriented environment where your development is valued and your contributions truly make an impact
Learn more about our EEO & Accommodations request here.