Clinical Research Associate II - Sponsor-Dedicated (Croatia)

About the role

Syneos Health is hiring a CRA II in Croatia, a sponsor-dedicated clinical monitoring position. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and ensures regulatory, ICH-GCP and protocol compliance. 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, evaluating site performance and escalating serious issues
• 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 storage and security
• Review the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with sites, prepare for investigator meetings and audits, and train site staff
• Support site identification, chart abstraction and data collection, 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
• Able to travel regularly up to 75%