An exciting opportunity has arisen to join the NHS Blood and Transplant Clinical Trials Unit (CTU), based in Cambridge or Oxford, as a Senior Clinical Trials Administrator.
NHS Blood and Transplant’s Clinical Trials Unit holds full registration with the UK Clinical Research Collaborative (UKCRC) and has expertise in all aspects of clinical trial planning, set up, conduct, analysis and publication. We collaborate with researchers in the design, conduct, analysis and publication of clinical trials and other prospective research studies, primarily in the fields of transfusion medicine, organ donation and transplantation, tissue and stem cell transplantation.
You will support our Clinical Trials Unit team and get involved in many aspects of our research studies, working in a friendly, professional environment. You will actively contribute by ensuring you provide administrative support in a proactive, timely and efficient manner.
You will have good communications skills, a team-orientated approach and the ability to plan and undertake work in an accurate, methodical and efficient manner. A good eye for detail is essential, as are strong administrative and IT skills. An understanding of the clinical trial process, clinical practice, research governance, and a familiarity with medical terminology would be advantageous.
The CTU offers great opportunities for career development and the chance to make a real difference to patients. You will receive ongoing support in your role to help you develop and achieve your career ambitions.
Main duties of the job
In this role you will play a key role in the operational management of clinical trials that will inform patient and donor care and equity of access to treatment. Your responsibilities will include :
- Working across the clinical operations and data management teams to provide administrative and data management support to one or more clinical trials being conducted by the Clinical Trials Unit (CTU).
- Assisting the Trial Managers in all aspects of running a clinical trial.
- Liaising with site research teams and external stakeholders in a professional, efficient manner.
- Developing expert knowledge and experience of trial methodology, operational practice and governance.
- Tracking and processing payments.
- Facilitating coordination of ethics, regulatory and research and development (R&D) submissions.
- Monitoring shared email accounts, highlighting and prioritising issues as appropriate
- Contribute to the design and testing of new trial databases.
- Managing trial supplies and assisting with the preparation of trial reports
- Arranging meetings and taking minutes
- General office duties for example photocopying and scanning documents
About You
Experience and Knowledge
- Experience of clinical trial administration
- Experience in design and testing of new clinical trial databases and associated documentation
- Experience of setting up and maintaining electronic and paper-based filing systems
- Trained and experienced in the use of one or more clinical trial database management systems e.g. MACRO, OpenClinica
- Supervisory experience
- Knowledge of the International Conference on Harmonisation (ICH), Good Clinical Practice Guidelines (GCP) and data protection legislation
- Highly competent in using Microsoft Office packages (Word, Excel, Visio, Publisher, Outlook and PowerPoint) with advanced keyboard skills
Qualifications and Training
- Honours degree in a relevant science / healthcare related subject and / or equivalent body of knowledge related to a scientific or healthcare field OR equivalent experience gained working in data management or clinical trial support
- Demonstrable workplace experience OR European Computer Driving Licence (ECDL) (part I & II) or ITQ2, or CLAIT II, or OCR (RSA) level 2 in text / word processing
- Demonstrates commitment to own continued professional development (CPD)
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