Clinical Research Associate II – Regionalized Galicia
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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 general medicine: Immunology, Cardiology, Hypertension, Diabetes or Ophthalmology.
• 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.
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Madrid, Community of Madrid, España Fortrea Jornada completaFortrea's FSP team is currently seeking a CRA II professionals to join the team in Galicia with specific experience in General Medicine, this is a permanent role. Summary of Responsibilities: * Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans. * Site and patient...
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Clinical Research Associate II
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Comunidad de Madrid, Comunidad de Madrid, España Fortrea Jornada completaFortrea's FSP team is currently seeking two CRA II professionals to join the team in Galicia. 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...
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Clinical Research Associate II – Regionalized Galicia
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Madrid, Community of Madrid, España Fortrea Jornada completaFortrea's FSP team is currently looking for a CRA II professionals to join the team in Galicia with experience in oncology. This is a fixed-term position to cover maternity leave. Summary of Responsibilities: • Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans. •...
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Madrid, España Fortrea Jornada completaFortrea's FSP team is currently seeking a CRA II professionals to join the team in Galicia with specific experience in General Medicine, this is a permanent role. 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:...
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Clinical Research Associate II – Regionalized Galicia
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Madrid, Community of Madrid, España Fortrea Jornada completaFortrea's FSP team is currently seeking two CRA II professionals to join the team in Galicia. 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...
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Clinical Research Associate II – Regionalized Galicia
Hace 1 semana
Madrid, España Fortrea Jornada completaFortrea's FSP team is currently looking for a CRA II professionals to join the team in Galicia with experience in oncology. This is a fixed-term position to cover maternity leave.Summary of Responsibilities:Clinical site monitoring: conducts routine, pre‑study, initiation, and close‑out visits, ensuring full compliance with project plans.Site and patient...