Clinical Research Associate II – Regionalized Galicia - Maternity Leave Cover
Fortrea · Madrid, Spain
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
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