AL Solutions is hiring a
Clinical Trial Associate in United Kingdom

Summary

The job is for a Clinical Trial Associate (CTA) position at a UK-based startup CRO offering remote work. The role involves overseeing document management, vendor selection, creating and maintaining quality management system, ensuring compliance with regulations, and assisting in budget negotiations and document creation.

Requirements

• Previous experience in a CTA, trial coordinator, or research nurse role would be advantageous
• Proficiency in relevant clinical research regulatory requirements, including GCP and UK statutory instruments

Responsibilities

• Oversee document management, monitor, assess, and archive trial master files
• Contribute to the selection, establishment, and supervision of vendors such as CROs, central labs, clinical study supply services, and electronic data capture (EDC) providers
• Aid in the creation, implementation, and maintenance of our quality management system (QMS) and procedures
• Collaborate with internal and external teams to ensure all study-related activities adhere to company SOPs, ICH GCP, and UK regulatory requirements
• Assist in site budget and contract negotiations, as well as the creation and review of vital documents such as protocols, patient information sheets, consent forms, case report forms, study plans, and clinical study reports

Preferred Qualifications

• Familiarity with essential management within a TMF would be beneficial
• Strong interpersonal and written communication skills
• Women's health experience is preferred
• Open to travel for business requirements within the UK

Benefits

• Competitive salary
• Great opportunity for progression to a CRA role