Clinical Research Associate II - Oncology (Lung) Studies, Madrid

About the role

Syneos Health is hiring a Clinical Research Associate II (CRA II) in Madrid to support oncology (lung) studies with a dedicated sponsor. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes chart abstraction and data collection. The position is open to Spanish-speaking candidates.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and protocol compliance
• Evaluate site performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess safety and data integrity risks
• Review source documents and CRFs, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and return
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Support recruitment and retention, enter tracking data and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection and knowledge of local study design requirements

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• 2-5 years of experience as a CRA
• Oncology (lung) phase I experience required
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Willingness to travel regularly, up to 75%

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP guidelines and relevant regulations