Clinical Study Specialist (Contract)

Artivion Emea; Navarra; Híbrido; EUR 42.000 - 62.000; Jornada completa

Descripción de la vacante

Artivion Emea busca un Clinical Research Associate III para trabajo remoto desde España. Serás responsable de monitorizar sitios de ensayo, gestionar visitas de inicio, monitoreo y cierre, y asegurar el cumplimiento de protocolo, GCP y requisitos regulatorios, apoyando a equipos multifuncionales.

Se requiere al menos 4 años de experiencia avanzada en monitorización de investigaciones clínicas, excelentes habilidades de comunicación en inglés y español, y la capacidad de orientar a CRAs junior.

Formación

• Minimum of 4 years of advanced experience in clinical research monitoring.
• In-depth knowledge of regulations and guidelines for human subjects trials.
• Excellent communication for site interaction, training and issue resolution.
• Ability to mentor junior CRAs and collaborate across teams.
• Experience with monitoring systems and source data verification.

Responsabilidades

• Manage all phases of clinical trial site activities, including site identification, initiation, monitoring and close-out.
• Conduct monitoring visits per protocol, GCP and regulatory requirements.
• Perform source data verification and data review to ensure patient safety and data integrity.
• Deliver trainings and support audit/inspection readiness.
• Mentor junior CRAs and contribute to process improvements.

Conocimientos

Clinical research monitoring

Regulatory knowledge

Communication skills

Mentorship

Monitoring systems

Source data verification

Data integrity

English & Spanish

Descripción del empleo

Descripción del trabajo At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Clinical Research Associate III – Home-Based in Spain (Spanish speaking candidates in France are also welcome) Minimum of 4 years of advanced experience in clinical research monitoring In-depth knowledge of regulations and guidelines related to clinical trials involving human subjects (e.g., Excellent communication skills for site interaction, training, and issue resolution Strong collaboration and mentorship abilities, with a passion for supporting and guiding junior team members Hands-on experience with monitoring systems, source data verification, and compliance tracking Based in Spain (candidates from France may be considered in case a candidate lives nearby the Spain/France border and eager to do cross border monitoring) Fluent communication in English and Spanish (Catalan is preferred, French optional) Independently manage all phases of clinical trial site activities, including site identification, initiation, monitoring, and close-out Conduct monitoring visits in accordance with study protocols, GCP, and applicable regulatory requirements Perform source data verification and data review to ensure patient safety, protocol compliance, and data integrity Conduct site training, initiation visits, and support audit and inspection readiness Collaborate closely with Clinical Operations, Data Management, Medical Affairs, and other cross-functional teams Support investigator meetings, coordinator meetings, and deliver presentations or training sessions when required Mentor junior CRAs and contribute to process improvements and best practices Participate in CAPA activities, quality initiatives, audits, and continuous improvement efforts Hybrid working model with flexibility Opportunities for growth and professional development.