Clinical Research Associate I - Barcelona or Madrid

About the role

Syneos Health is hiring a Clinical Research Associate I (CRA I) based in Barcelona or Madrid, working as a Functional Service Provider (FSP). The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, and requires at least 1 year of experience in a CRA role.

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, check CRFs and resolve queries, supporting 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 manage site-level activities within budget and timeline
• Act as liaison with site personnel, train sites and attend investigator and sponsor meetings
• Support audit readiness and follow-up actions
• For Real World Late Phase studies, the title is Site Management Associate, with site support, chart abstraction and collaboration with sponsors and local staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• At least 1 year of experience in a CRA role
• Knowledge of Good Clinical Practice/ICH guidelines and other regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Willingness to travel regularly up to 75%