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 quality standards for trial monitoring activities.
• Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.
• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Tracks and supervises collection of ongoing study data for purpose of regular project status reporting.
• Collects and reviews regulatory documents as required.
• Prepares site visit reports and telephone contact reports.
• Maintains and updates CTMS in compliance with SOPs and study-specific directives.
• Aims to pro-actively prevent and/or mitigate issues.
• Acts as the main line of communication between the project team and the site staff.
• Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities.

Requirements

• Experience in clinical research monitoring.
• Strong understanding of GCP and ICH guidelines.
• Ability to work independently and in a team environment.
• Excellent communication and organizational skills.
• Proficient in managing multiple tasks and projects simultaneously.
• Experience with regulatory document preparation.
• Strong analytical and problem-solving abilities.
• Ability to travel as needed for site visits.
• Knowledge of clinical trial management systems (CTMS).
• Experience in liaising with investigators and site staff.

Benefits

• Opportunity to work in a dynamic and supportive environment.
• Flexible work arrangements, including hybrid and remote options.
• Professional development and training opportunities.
• Competitive salary and benefits package.
• Chance to contribute to meaningful clinical research projects.