other
Posted May 7CRA 1 / CRA 2 - Full Service Operation Model - Porto, Portugal
at Fortrea
On-site
Responsibilities
- Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.
Requirements
- 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.
- 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.
Additional details
- 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
- 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.
- 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 .