31 ago
|
Artivion EMEA
|
Lugo
31 ago
Artivion EMEA
Lugo
Descripción del trabajo
At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Asegúrese de inscribirse veloz, ya que se espera un gran volumen de solicitudes. We are hiring a Clinical Research Associate III - Home-Base in Spain (Spanish speaking candidates in France are also welcome).
Your Strength
- 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., ISO 14155, GCP, MDR, EU, FDA)
- Ability to independently manage 10-15 study sites from start-up through close-out
- 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
- Strong organizational skills with the ability to manage multiple priorities in a dynamic environment
- Willingness to travel regularly for site visits and investigator meetings across France and Spain
- 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)
Your Contribution
- 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
- Act as the primary contact for investigational sites, ensuring compliance and providing ongoing support
- Build and maintain strong relationships with investigators, study coordinators, and site personnel
- Identify study risks, recommend solutions, and ensure timely resolution of site-related issues
- 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
Our Strength
- A mission-driven company focused on saving lives
- International and collaborative MedTech environment
- Hybrid working model with flexibility
- Opportunities for growth and professional development
- Innovative products and meaningful clinical impact
We look forward to receiving your application documents in English through our online application system.
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📌 Clinical Research Associate - Monitoring Experience Required (Lugo)
🏢 Artivion EMEA
📍 Lugo