Cra 2

We are looking for a Clinical Research Associate II (CRA2) to join our team and support the successful execution of clinical trials by performing high‑quality monitoring and site management activities. In this role, you will ensure that study sites operate in compliance with protocols, GCP/ICH guidelines, regulatory requirements, and sponsor expectations while maintaining strong communication and collaboration with site staff and internal teams.

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; maintain regular communication to support expectations and resolve issues.
• Assess site performance and ensure adherence to protocol, study procedures, and regulatory compliance; escalate quality issues when appropriate.
• Track study progress (regulatory submissions, approvals, enrollment, CRF completion, and data queries) and support start‑up activities when needed.
• Ensure essential documents are properly maintained in the TMF and verify ISF compliance with GCP and local regulatory standards.
• Document site management activities through timely monitoring visit reports, follow‑up letters, and required study documentation.
• Collaborate with cross‑functional study team members to support operational excellence.
• When applicable, support site-level recruitment planning and site financial management.

Qualifications

• 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.
• Proficiency in Microsoft Word, Excel, PowerPoint, and digital tools.
• Strong written and verbal communication skills in English.
• Excellent organizational, time‑management, and problem‑solving abilities.
• Ability to build strong working relationships with sites, colleagues, and sponsors.