Clinical Research Associate – Future Roles

About the role

Syneos Health is seeking Clinical Research Associates to support site qualification, initiation, monitoring and close‑out activities for real‑world late‑phase studies in Romania. The role involves both on‑site and remote interactions with investigators, ensuring compliance with ICH‑GCP, local regulations and study protocols.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits, ensuring regulatory and protocol compliance.
• Review source documents, verify data entered in case report forms, and resolve queries within agreed timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and document activities through trip reports and communication logs.
• Support subject recruitment, retention, and awareness strategies, and act as liaison between site personnel and central monitoring teams.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines, with ability to apply them to site monitoring activities.
• Excellent communication and interpersonal skills, with willingness to travel up to 75% of the time.
• Ability to adapt quickly to changing priorities and manage site‑level activities to meet project timelines.

Required skills

• Good Clinical Practice (GCP) and ICH guideline expertise.
• Electronic Data Capture (EDC) systems proficiency.
• Source document review and query resolution.
• Investigational product handling and inventory management.