Associate Clinical Research Associate – Clinical Operations

About the role

We are looking for a motivated Associate Clinical Research Associate to join MSD’s clinical operations team in Bucharest. The CRA will act as the primary site contact, managing study sites through all phases of clinical trials while ensuring high‑quality execution and compliance with regulations.

Key responsibilities

• Serve as the main site manager for assigned sites, building and maintaining strong relationships throughout the study lifecycle.
• Conduct remote and on‑site monitoring visits (validation, initiation, monitoring, close‑out) and produce clear visit reports.
• Collect, review, and maintain regulatory documentation in the eTMF and ensure data quality in the CTMS.
• Coordinate site readiness activities with internal sponsor teams and participate in site selection and validation.
• Identify and resolve site performance or compliance issues, escalating when necessary.

Required profile

• Associate’s degree in a scientific/healthcare field with ≥3 years relevant experience, or Bachelor’s degree with ≥6 months experience, or non‑scientific degree with ≥2 years experience.
• Fluent in Romanian and English, both written and spoken.
• Strong understanding of clinical research, GCP/ICH standards, and local regulations.
• Ability to travel domestically and internationally 65‑75 % of the time.

Required skills

• Proficiency with MS Office.
• Experience using clinical trial management systems (CTMS) and electronic trial master file (eTMF) platforms.
• Use of clinical applications on desktop, tablet, and mobile devices.
• Basic automation, analytics, and approved AI tools (with guidance).
• Good Documentation Practices.

What we offer

• Opportunity to contribute to the successful delivery of clinical research studies.
• Exposure to a collaborative, multicultural, and highly regulated global environment.
• Professional growth through hands‑on site management and monitoring experience.
• Chance to make a meaningful impact on trial quality, compliance, and patient safety.