Senior Clinical Research Associate - Cell Therapy - Remote

Overview

The Senior Clinical Research Associate (CRA) plays a crucial role in managing clinical studies and ensuring compliance with international guidelines and local regulations, contributing to the development of therapies that benefit patients.

In Short

• Local responsibility for study delivery at allocated sites.
• Collaboration with other CRAs and local study teams.
• Monitoring study conduct and ensuring compliance with ICH-GCP.
• Site management, including selection and training of investigators.
• Preparation and monitoring of study documents and supplies.
• Regular participation in Local Study Team meetings.
• Implementation of risk-based quality management principles.
• Timely resolution of study-related issues.
• Ensuring sites are inspection-ready at all times.
• Collaboration with local Medical Science Liaisons.

Requirements

• Bachelor’s degree in life sciences or equivalent.
• Excellent attention to detail and communication skills.
• Good knowledge of ICH-GCP and local regulations.
• Ability to manage multiple tasks with conflicting deadlines.
• Experience in clinical study management.
• Fluency in English and local languages.
• Ability to travel nationally/internationally as required.
• Proficient in remote collaboration.
• Good analytical and problem-solving skills.
• Team-oriented with flexibility to adapt to shifting demands.

Benefits

• Opportunity to contribute to improving global health.
• Work in a collaborative and empathetic environment.
• Comprehensive training and development opportunities.
• Access to a global network of professionals.
• Competitive salary and benefits package.