Clinical Research Associate II - Madrid (Sponsor Dedicated)

About the role

Syneos Health is hiring a CRA II for a sponsor-dedicated project in Madrid, working in a hybrid setting. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the title used is Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• 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 release
• Review the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, and enter data into tracking systems
• Act as liaison with sites, prepare for investigator meetings and support audit readiness
• Support site support throughout the study lifecycle, chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff
• Identify out-of-scope activities, suggest potential sites and may train junior staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice/ICH guidelines and other regulatory requirements
• Good computer skills and openness to new technologies
• Excellent communication, presentation and interpersonal skills
• Willingness to travel regularly up to 75%