Clinical Trial Associate
3 weeks ago
- In this position, you will be responsible for overseeing document management, monitoring, assessment, and archival of trial master files
- Contribute to the selection, establishment, and supervision of our vendors, which may include 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 both 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
- Undertake any other assigned responsibilities
- 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
- Familiarity with essential management within a TMF would be beneficial
- Strong interpersonal and written communication skills
- Womens health experience is preferred
- Open to travel for business requirements within the UK
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