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, assessing compliance with regulatory and protocol requirements.
• Review source documents, verify data entry in case report forms, and manage query resolution to meet timelines.
• Oversee investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
• Document activities through letters, reports, and logs, and support recruitment, retention and patient awareness strategies.

Required profile

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

Required skills

• Good Clinical Practice (GCP) / ICH guideline knowledge
• Site monitoring and management experience
• Investigational product handling and reconciliation
• Source document review and data verification
• Proficiency with electronic data capture systems