Adv Clinical Pharmacist - Clinical Trials

Due to expansion the of our service an exciting opportunity has arisen for an enthusiastic, self motivated band 8a pharmacist to join the pharmacy Clinical Trials Management team at Leeds Teaching Hospitals NHS Trust. Applicants should have an active interest in clinical trials and an understanding of good clinical practice GCP.

This is a split post working with Aseptics Services to support their safe delivery of clinical trials. You will provide senior aseptic services cover as part of a wider team, working closely with the team to ensure safe and appropriate supply of medicines. The option to work as part of the aseptic service support to the radiopharmacy team, with relevant experience, is available.

This post will provide support for clinical trials running at all 3 sites. It is an exciting time to work in research as work is currently underway on developing two new state of the art hospitals with plans to create a world class hub for innovation. You will, as part of your portfolio, support the growing number of early phase studies and ATIMPs (Advanced Therapy Investigational Medicinal Products) especially for the vaccine portfolio and the Childrens Hospital.You will work closely with a number of internal and external teams including clinical pharmacists, aseptic services, the Clinical Research Facility team, investigators and research nurses, the Trust Research and Innovation team and pharmaceutical companies, The main duties for staff working in this role are

Provide advice and information in relation to all medicines related aspects of R and I activities, including clinical trials, within the Trust to ensure compliance with national legislation and guidelines.

Review and improve current Medicines Management and Pharmacy Services CSU (MMPS) clinical trial set up processes to provide a service that meets the Trusts performance in initiation and delivery targets for NIHR portfolio clinical trials.

Provide support and advice to clinical pharmacists in the review of new protocols. Liaise with aseptics, investigators, trial sponsors and Trust R&I regarding medicines management issues raised as part of the review.

Check and approve final versions of IMP (investigational medicinal product) management procedures for each trial. Perform the Pharmacy Green Light process for Clinical Trials.

To support Aseptics Services with the set up and ongoing management of Clinical Trials. Providing the senior link between pharmacy clinical trials and aseptics services. Coordinating workload and approving trial specific worksheets

Assist the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies and regulatory agencies.

Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies and procedures relating to clinical trials.

Leeds Teaching Hospitals NHS Trust is one of the largest teaching hospitals in the UK with a large number of specialised and highly specialised services. It has an established reputation as a Centre of Excellence for delivering high quality research and innovation on a large scale with pharmacy currently supporting over 350 clinical trials across all hospital sites.

Leeds is a wonderful city to work in and LTHT is an organisation that puts its patients first and highly values and supports its staff. Pharmacy is a forward thinking department that values the contribution of all our staff and is recognised in the organisation for our collaborative working as we continuously support our workforce to develop to their potential in delivering the best patient care.