Clinical Research Associate II - Pulmonary Hypertension Studies

About the role

Syneos Health is hiring a CRA II in Barcelona for a sponsor-dedicated project focused on pulmonary hypertension studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, 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 and administration, and ensure proper labelling, import and return
• Review the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, and enter data into tracking systems
• Manage site-level activities, communicate with sites and prepare for audits
• Attend investigator meetings, global monitoring meetings and clinical training, and suggest potential sites

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel regularly up to 75%