Senior Clinical Trials Assistant

3 months ago


Leeds, United Kingdom Leeds Teaching Hospitals Full time

JOB PURPOSE The post-holder is responsible for supporting and administering all clinical research within the AMR and Infection theme of the Leeds NIHR Biomedical Research Centre (BRC), under the guidance of the Principal Clinical Scientist.. The post-holder must ensure that all trial protocols are adhered to in line with ICH-GCP practice. The post-holder will act as Assistant to the Principal Clinical Scientist and other senior researchers and will liaise with all internal and external parties involved in the setting up, maintenance and closure of research studies. The post-holder will assist with administrative aspects of clinical research/trials management including costings.

The post holder may be expected to interact with patients and their families in relation to the requirements of the research study and be able to work without supervision in some areas. As part of this post you may carry out the informed consent process with patients as appropriate and following specific training, and administer the necessary paperwork and maintaining a clear audit trail. You will have responsibility for logging of all patients into the EDGE research database and departmental clinical trials database ensuring information is accurate and up-to-date. Your role may also include some clinical skills such as taking clinical observations, venepuncture, taking electrocardiography (ECG) tracings and processing clinical samples.

JOB DIMENSIONS The post holder will be working within the NIHR Leeds BRC with a large portfolio of studies covering AMR and Infection. Studies include those funded by the NIHR, commercial trials, academic studies and early phase (experimental) therapies. Clinical trials support is provided to the research team and the numbers of patients in trials can range from 1 to 50+. The post holder is expected to meet all reporting procedure timescales and international, national and local standards for clinical trial governance.

The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required.



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