Fortrea
Clinical Research Associate II – Regionalized Galicia - Maternity Leave Cover
- Madrid
- Full-time
- Posted
Skills
Job description
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 .