Clinical Research Associate II - Dedicated Sponsor, Madrid

About the role

Syneos Health is hiring a CRA II (titled Site Management Associate II for Real World Late Phase studies) in Madrid, working on a dedicated sponsor. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes site support throughout the study lifecycle.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• 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, reconcile it with the Trial Master File and ensure document archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with sites, prepare for investigator meetings and audits, and train site staff
• Support real world late phase studies: chart abstraction, data collection and knowledge of local study design requirements
• Collaborate with sponsor affiliates, medical science liaisons and local country staff, and suggest potential sites

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 willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Able to travel regularly up to 75%