Senior Clinical Research Associate - Remote

Overview

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

In Short

• Govern highest possible quality standards for trial monitoring activities.
• Conduct all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
• Monitor activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines.
• Perform efficient site management in line with study budget.
• Prepare and submit quality Site Visits Reports and Contact reports.
• Maintain and update CTMS in compliance with SOPs and study-specific directives.
• Act as Document Owner for collected documents.
• Conduct co-monitoring as needed.
• Provide functional assistance to the project team members with administrative, logistical, and practical issues.
• Liaise with project team members and Sponsor to track study progress and milestones.

Requirements

• Experience in clinical research and monitoring.
• Knowledge of Good Clinical Practice (GCP) and regulatory requirements.
• Strong organizational and communication skills.
• Ability to work independently and manage multiple tasks.
• Experience with clinical trial management systems (CTMS).
• Ability to travel as required.

Benefits

• Opportunity to work with a dedicated team in a growing company.
• Flexible working environment.
• Professional development opportunities.
• Competitive salary and benefits package.