Clinical Research Associate II - Remote Poland

About the role

Syneos Health is hiring a Clinical Research Associate II (CRA II) for a remote position in Poland. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements.

Key responsibilities

• 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
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Support recruitment and retention, enter tracking data and prepare sites for audits
• Attend investigator meetings, global project meetings and clinical training, and act as liaison with sites or with a Central Monitoring Associate
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection and collaboration with sponsor affiliates, medical science liaisons and local country staff

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Ability 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