Clinical Research Associate
The Project Management team manage and deliver specific projects which require an understanding of the clinical trial process. These projects will include both academic and commercially-sponsored clinical trials and will play a key role in the development of Perspectum Diagnostics’s products and services. The CRA will provide monitoring and site management support for UK-based clinical trials in metabolic and/or liver disease. Experience in paediatric trials is essential for this role.
- Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3, focused on metabolic and/or liver disease
- Perform source document verification and case report form review
- Perform regulatory document review
- Conduct study drug/substance inventory
- Perform adverse event and serious adverse event reporting
- Assess patient recruitment and retention
- Liaise with broader study team within Perspectum to drive successful study execution
Skills and Requirements: Essential
- Proven CRA experience
- Experience with Paediatric trials
- Broad knowledge of medical terminology and clinical patient management
- Basic knowledge of drug therapy techniques and clinical research methodologies
- Knowledge of UK clinical study regulations, including ethics submissions
- Ability to problem solve over a complex range of tasks subject to competing contractual, financial, personnel and time constraints
- Organisational skills and the ability to rapidly prioritise tasks in response to unexpected opportunities or risks
- Good communication skills, both oral and written.
- Excellent IT skills, primarily Office (Word, PowerPoint, Excel)
- Interpersonal skills and the ability to work in a team
Skills and Requirements: Desirable
- ICH-GCP Trained
Interested in this position?
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