Clinical Research Associate II – Single Sponsor – Bucharest

About the role

Syneos Health is seeking a Clinical Research Associate II to conduct on‑site and remote monitoring of clinical research studies in Bucharest. The role ensures compliance with Good Clinical Practice and regulatory requirements while supporting trial execution.

Key responsibilities

• Perform on‑site and remote monitoring visits, reviewing protocols, informed consent forms, and case report forms.
• Create and maintain monitoring plans, checklists, and templates to ensure quality monitoring.
• Coordinate site visits, track study progress, and resolve operational issues.
• Document monitoring activities, write reports, follow‑up letters, and action plans.
• Collaborate with investigators, site staff, and cross‑functional teams to support smooth trial conduct.

Required profile

• Bachelor's degree in a related field or equivalent experience.
• 2–4 years of experience in clinical research monitoring.
• Strong knowledge of GCP guidelines and regulatory requirements.
• Excellent communication, interpersonal, and analytical skills.
• Ability to work independently and manage multiple priorities.

Required skills

• Proficiency with clinical trial management systems.
• Proficiency in Microsoft Office Suite.
• Certified Clinical Research Associate (CCRA) or equivalent certification (preferred).