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 ensures regulatory, ICH-GCP and protocol compliance. For Real World Late Phase studies, the CRA I uses the business card title of Site Management Associate.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, evaluating site performance and escalating serious issues
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents, check CRFs for accuracy and completeness, 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 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 prepare for audits
• For Real World Late Phase: site support throughout the study lifecycle, chart abstraction and data collection, and collaboration with sponsor affiliates and local country staff

Required profile

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