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

• Governs highest possible quality standards for trial monitoring activities.
• Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
• Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines.
• Performs efficient site management in line with study budget.
• Prepares and submits quality Site Visits Reports and Contact reports.
• Maintains and updates CTMS in compliance with SOPs and study-specific directives.
• Acts as Document Owner for collected documents.
• Conducts co-monitoring as needed.
• Provides functional assistance to the project team members with administrative, logistical, and practical issues.
• Liaises with project team members and Sponsor to track study progress and milestones.

Requirements

• Experience in clinical research and monitoring.
• Strong understanding of GCP and regulatory requirements.
• Excellent communication and interpersonal skills.
• Ability to work independently and manage multiple tasks.
• Proficiency in using CTMS and other clinical trial management tools.

Benefits

• Opportunity to work with a dedicated team in a growing company.
• Remote work flexibility with travel opportunities.
• Competitive salary and benefits package.
• Professional development and training opportunities.