CRA II (Multisponsor) - Hybrid Madrid or Barcelona

About the role

Syneos Health is hiring a CRA II (multisponsor) for a hybrid position in Madrid or Barcelona. The role covers site qualification, initiation, interim monitoring, site management and close-out, with on-site or remote activities, 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 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, labelling and release, and reconcile the Investigator Site File with the Trial Master File
• Document activities, support recruitment and retention, and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For Real World Late Phase studies: chart abstraction, data collection and knowledge of local study design requirements

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• At least 1 year of independent on-site monitoring
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation and interpersonal skills
• Willingness to travel regularly up to 75%

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Working knowledge of ICH/GCP guidelines, regulations and company SOPs