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, dispensing and labelling
• Review the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, and manage site-level communication to meet project timelines
• Act as liaison with site personnel, attend investigator and sponsor meetings, and prepare sites for audits
• Mentor junior CRAs, train and sign off visits, and handle country-level informed consent forms and chart abstraction

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• At least 5 years of experience in pharmaceutical or biotechnology industry monitoring as a Clinical Research Associate
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Ability to travel regularly up to 75%

Required skills

• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Basic critical thinking skills