Site Monitor II - Remote

Overview

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

In Short

• Ensures regulatory, ICH-GCP, and protocol compliance.
• Evaluates site and staff performance, recommends site-specific actions, escalates key issues promptly, and develops action plans.
• Maintains current knowledge of ICH-GCP, regulations, and company SOPs/processes.
• Checks the site and external facilities, equipment supplies for adequate trial conduct.
• Conducts source document review and verification of appropriate site source documents and medical records.
• Manages reporting of protocol deviations and appropriate follow-up.
• Enters data into tracking systems as required.
• Conducts follow-up for escalated adverse event monitoring report queries.
• Conducts monitoring activities using different methods (on-site and remote).
• Understands project scope, budgets, and timelines, managing site-level activities and communication.

Requirements

• Strong understanding of clinical trial processes and regulations.
• Experience in site monitoring and compliance.
• Excellent communication skills.
• Ability to work independently and as part of a team.
• Strong organizational skills.
• Adaptability to changing priorities.

Benefits

• Opportunity for personal and professional growth.
• Dynamic and ambitious work environment.
• Collaborative team culture.