Remote/On-Site CRA — Real World Late Phase

3212 Syneos Health Clinical Spain, S.L.U.; Madrid; Híbrido; EUR 32.000 - 52.000; Jornada completa

Descripción de la vacante

Syneos Health Clinical Spain, S.L.U. seeks a Clinical Research Associate to monitor study sites in Madrid, ensuring regulatory and protocol compliance and safeguarding patient safety. You will manage site initiation, monitoring visits, and close-out activities, while maintaining rigorous data quality and informed consent processes.

You will collaborate with investigators, manage ISF/TMF, and support audit readiness, with travel up to 75% across assignments in the Real World Late Phase as needed.

Formación

• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Strong communication and interpersonal skills.
• Ability to manage travel up to 75% regularly.

Responsabilidades

• Performs site qualification, initiation, monitoring, management and close-out visits (on-site or remote) ensuring regulatory and protocol compliance.
• Evaluates site performance and escalates issues; develops corrective actions with project guidance.
• Maintains knowledge of ICH/GCP guidelines and SOPs.
• Verifies informed consent processes and protects subject confidentiality.
• Assesses safety and data integrity factors at investigator sites.
• Supports CMP/SMP activities, source document review, and CRF data accuracy.
• Manages ISF reconciliation with TMF and archiving requirements.
• Assists site recruitment, retention and awareness strategies; data tracking and reporting.
• Understands project scope, budgets and timelines; coordinates site-level activities.
• Adapts to changing priorities; may liaison with site personnel and other CRA teams.
• Attends Investigator Meetings; participates in global project meetings and training.
• Contributes to audit readiness and supports follow-up actions.
• For Real World Late Phase, supports study lifecycle and local country collaboration.

Conocimientos

GCP/ICH Guidelines

Site Monitoring

Regulatory compliance

Communication skills

Educación

Bachelor’s degree or RN

Descripción del empleo

Syneos Health Clinical Spain, S.L.U. seeks a Clinical Research Associate to monitor study sites in Madrid, ensuring regulatory and protocol compliance and safeguarding patient safety. You will manage site initiation, monitoring visits, and close-out activities, while maintaining rigorous data quality and informed consent processes.

You will collaborate with investigators, manage ISF/TMF, and support audit readiness, with travel up to 75% across assignments in the Real World Late Phase as needed.