Clinical Research Associate II - Sponsor-Dedicated (Croatia)

About the role

Syneos Health is hiring a CRA II in Croatia, dedicated to a single sponsor, working on clinical studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely. For Real World Late Phase studies, the CRA II uses the business card title Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or GPP 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 release
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level activities against budget and timeline
• Act as liaison with site personnel, prepare for and attend investigator meetings and training, and support audit readiness
• Support site identification, chart abstraction and data collection, and suggest potential sites based on local knowledge

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice/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%