Remote CRA I – Site Monitoring & Compliance

SmartRecruiters, Inc.; Madrid; A distancia; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Clinical Research Monitor to oversee activities at investigative sites for Phase 1-4 trials, ensuring protocol adherence and regulatory compliance. The role emphasizes data integrity, safety reporting, and readiness for regulatory inspections.

The ideal candidate has at least 1 year of clinically-related experience, preferably 6 months in monitoring or as a Study Coordinator, and a health-related qualification; Clinical Trials Master’s degree is preferred.

Formación

• Appropriate tertiary qualification in health-related field; Clinical Trials Master’s Degree preferred.
• Minimum 1 year of clinically-related experience; 6 months preferred in monitoring or as Study Coordinator.
• Experience with on-site monitoring of investigational trials and knowledge of regulatory requirements.

Responsabilidades

• Monitors activities at clinical investigative sites to ensure protocol execution and compliance.
• Ensures adherence to GCPs, ICH Guidelines, SOPs and monitoring plans.
• Overviews site personnel activities and ensures action plans for compliance; ensures regulatory inspection readiness.
• Ensures data quality and timely reporting of safety events by site personnel.
• Trains site personnel on protocol and regulatory requirements with project team input.
• Manages investigator payments and negotiates site agreements; completes expense reports.
• Identifies potential investigators/sites to support planned studies.

Conocimientos

Clinical monitoring

Site management

Data quality assurance

Regulatory knowledge

Planning & organization

Communication

Educación

Clinical Trials Master’s Degree

Descripción del empleo

AbbVie is seeking a Clinical Research Monitor to oversee activities at investigative sites for Phase 1-4 trials, ensuring protocol adherence and regulatory compliance. The role emphasizes data integrity, safety reporting, and readiness for regulatory inspections.

The ideal candidate has at least 1 year of clinically-related experience, preferably 6 months in monitoring or as a Study Coordinator, and a health-related qualification; Clinical Trials Master’s degree is preferred.