Senior CRA I / II - Sponsor Dedicated, Madrid

About the role

Syneos Health is hiring a Senior CRA I / II for a sponsor-dedicated clinical monitoring assignment in Madrid, Spain. 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 for Real World Late Phase studies.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and protocol compliance
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries
• Check site compliance with electronic data capture requirements and, if needed, inspect investigational product inventory, storage, security and dispensing
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Support subject recruitment and retention, enter observations and action items into tracking systems, and prepare for audits
• Manage site-level activities and communication, and act as liaison with site personnel or with a Central Monitoring Associate
• Attend investigator meetings, global clinical monitoring meetings and clinical training sessions, and guide sites toward audit readiness
• Train or mentor junior CRAs, and sign off visits for them when assigned
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection, country-level informed consent forms, and collaboration with the RWLP regulatory team

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• At least 5 years of experience in pharmaceutical or biotechnology industry monitoring as a Clinical Research Associate
• Ability to manage regular travel of up to 75%

Required skills

• Knowledge of Good Clinical Practice and ICH guidelines and other applicable regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills