We are seeking an experienced Clinical Research Associate (CRA) to support monitoring and site management activities across multiple studies. The role involves close collaboration with study teams, sites, and cross-functional stakeholders, with a strong commitment to patient safety, data integrity, and product quality.

La información a continuación detalla los requisitos del puesto, la experiencia esperada del candidato y las cualificaciones correspondientes.Key Responsibilities

- - Conduct on-site and remote monitoring activities, including visit preparation, follow-up, site contact, and report writing.
- Support site start-up activities, including EC/CA submissions, contract negotiation, and essential document collection.
- Attend study meetings and collaborate with cross-functional teams and sites throughout all study phases.
- Provide support in audit preparation and responses.
- Schedule and conduct monitoring visits according to the study monitoring plan.
- Review informed consents, regulatory files, and site study documentation, ensuring compliance with study protocols and applicable regulations (ISO 14155:2020,



ICH-GCP).
- Identify and report compliance issues, working with project management to ensure timely resolution.
- Ensure monitoring reports are finalized within 28 days of each site visit.
- Provide interim site management services, including remote monitoring, as required.

Qualifications
- - Prior CRA experience (on-site and remote) within medical devices or pharma (ISO 14155:2020, ICH-GCP).
- Strong knowledge of EC/CA submission processes and regulatory requirements.
- Excellent organizational and communication skills, with ability to collaborate across cross-functional teams.
- Proactive, detail-oriented, and committed to patient safety and quality standards.

This opportunity offers involvement in multiple excluively sponsor studies, exposure to a wide range of clinical operations, and the chance to work in a dynamic, high-quality environment. xcskxlj

#J-18808-LjbffrHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.

📌 Clinical Research Associate -remote- (Madrid)
🏢 Talent
📍 Madrid