Senior Home-Based CRA III – Spain

Artivion Emea; Palencia; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Artivion busca un Clinical Research Associate III — Home-Based en España. Serás enlace principal entre sitios de ensayo, coordinarás monitoreo desde inicio hasta cierre y asegurarás cumplimiento con GCP, ISO 14155, MDR y regulaciones EU/FDA.

Viajarás regularmente por Francia y España para visitas y reuniones. Se requieren al menos 4 años de experiencia en monitorización clínica, habilidades de comunicación excelentes y capacidad de mentoría.

Formación

• Minimum of 4 years of advanced experience in clinical research monitoring
• In-depth knowledge of GCP, ISO 14155, MDR, EU, FDA guidelines for human-subject trials
• Ability to independently manage 10–15 study sites from start-up to close-out
• Excellent communication for site interaction, training, and issue resolution
• Strong collaboration and mentorship abilities supporting junior team members
• Hands-on experience with monitoring systems and source data verification
• Strong organizational skills to manage multiple priorities
• Willingness to travel for site visits across France and Spain
• Based in Spain; cross-border monitoring considered near France
• Fluent English and Spanish; Catalan preferred

Responsabilidades

• Independently manage all phases of site activities (initiation, monitoring, close-out)
• Conduct monitoring visits per protocol, GCP and regulatory requirements
• Act as primary contact for investigational sites, ensuring compliance
• Build and maintain relationships with investigators and site staff
• Identify risks, recommend solutions, resolve issues
• Perform SDV and data review for safety and integrity
• Conduct site training and initiation visits; support audits
• Collaborate with Clinical Operations, Data Management, Medical Affairs
• Support investigator meetings and training
• Mentor junior CRAs and drive process improvements
• Participate in CAPA, audits, and quality initiatives

Conocimientos

Clinical monitoring

Regulatory knowledge

Site management

Communication

Mentorship

Source data verification

Organization

Travel readiness

Bilingual English/Spanish

Descripción del empleo

Artivion busca un Clinical Research Associate III — Home-Based en España. Serás enlace principal entre sitios de ensayo, coordinarás monitoreo desde inicio hasta cierre y asegurarás cumplimiento con GCP, ISO 14155, MDR y regulaciones EU/FDA.

Viajarás regularmente por Francia y España para visitas y reuniones. Se requieren al menos 4 años de experiencia en monitorización clínica, habilidades de comunicación excelentes y capacidad de mentoría.