Clinical Research Associate

About the role

We are seeking an experienced Clinical Research Associate to support the execution of clinical trials through high‑quality monitoring and site management activities. You will ensure study sites comply with protocols, GCP/ICH guidelines, regulatory requirements, and sponsor expectations.

Key responsibilities

• Conduct selection, initiation, monitoring, and close‑out visits according to GCP, ICH guidelines, and the contracted scope of work.
• Work with sites to develop and track subject recruitment plans aligned with project timelines.
• Provide protocol and study‑specific training to site personnel and maintain regular communication.
• Assess site performance, ensure adherence to protocol and regulatory compliance, and escalate quality issues when appropriate.
• Track study progress, including regulatory submissions, approvals, enrollment, CRF completion, and data queries.
• Maintain essential documents in the TMF and verify ISF compliance with GCP and local regulatory standards.
• Document site management activities through monitoring visit reports, follow‑up letters, and required study documentation.
• Collaborate with cross‑functional study team members to support operational excellence.

Required profile

• Bachelor’s degree in a scientific or healthcare discipline, or equivalent experience.
• Minimum of 1 year of on‑site monitoring experience.
• Good knowledge of GCP, ICH guidelines, and clinical research processes.
• Strong written and verbal communication skills in English.
• Excellent organizational, time‑management, and problem‑solving abilities.

Required skills

• Proficiency in Microsoft Word
• Proficiency in Microsoft Excel
• Proficiency in Microsoft PowerPoint
• Experience with digital monitoring tools