Advanced Specialist Pharmacist – Clinical Trials and Research inCheadle inCheadle PUBLISHED
MON 16 DEC 2024
Key responsibilities include the management of investigational medicinal products, patient counseling on trial-related medications, and ensuring efficient communication with sponsors and researchers. The position requires collaboration with various stakeholders, development of policies for safe medication management, and active involvement in trial preparations and inspections. The pharmacist will play a crucial role in maintaining compliance with clinical research regulations and contributing to the overall success of clinical trials within the organisation.
Are you a UK registered (GPhC) Pharmacist with experience of hospital pharmacy looking for a chance to develop skills in the area of clinical trials and research? If so, we have an opportunity of a one-year fixed term in this area that would give you that chance!
We have extensive experience of running industrially and academically sponsored clinical trials and research projects, with a dedicated Research and Innovation team with affiliation to Keele University.
For this role it is desirable that you have experience of clinical trials and have current GCP certification, but not essential, as we are able to support your training needs in this area.
The job base is at Cheadle Hospital in Cheadle, Staffordshire, with potential involvement in trial activity at St George's Hospital in Stafford and at Redwoods Centre Pharmacy in Shrewsbury.
Please take time to read the Job Description and Person Specification and contact us if you would like any further information.
Support the development and running of clinical trials, academic and non-academic research in MPFT, working closely with the Advanced Specialist Pharmacist High Cost Drugs Homecare and Clinical Trials Pharmacist.
Provide professional input and knowledge in the management of clinical trial services across MPFT.
Support the safe, effective and efficient management and delivery of pharmacy clinical and operational services at the Haywood Community Hospital and all associated community hospitals/clinic settings
To ensure that all trials are conducted in accordance with the highest possible standards, and in compliance with the principles of GCP (Good Clinical Practice), Good Dispensing Practice and Good Manufacturing Practice.
Support meeting all standards of practice and performance targets for operational services. This includes the distribution of all medicines, dispensing services, clinical governance and quality assurance.
Support the delivery of a comprehensive clinical pharmacy providing specialist information and advice to all members of the multi-disciplinary team, to maximise patient pharmaceutical care and to improve mental and physical health care for patients and service users.
See job description for full details
About us
KEY RESPONSIBILITIES
Clinical Trials
1. Responsible for the development of the pharmaceutical service for clinical trials by reviewing clinical trial protocols as part of study feasibility, comment on compliance with regards to:
a. Legal, ethical and pharmaceutical viewpoint and in terms of capacity and facilities available within the pharmacy.
b. Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management
2. To assist in efficient and set up of clinical trials, including setting up Pharmacy site files and ensuring they are well maintained and ready for MHRA inspection.
3. Responsible for clinically screening clinical trial prescriptions and resolve identified problems with the prescriber.
4. Ensure accurately check-dispensed medication (clinical trial and supportive care) and associated documentation (e.g. accountability logs, worksheets) is complete in a timely manner.
5. To counsel patients on their medication in all clinical trial specialty areas. To advise investigators, research nurses and clinical pharmacists as needed about prescribing decisions, toxicity management, treatment administration and any other clinical trial patient specific queries. To liaise with production pharmacy and specialist clinical pharmacy teams in respect of clinical trial patients as needed
6. Responsible for coordinating clinical trials by ensuring compliance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, the MHRA - Medicine for Human Use (Clinical Trials) and European Union clinical trial regulations and implement any recommendations from inspections by official bodies such as MHRA and NIHR Clinical Research Network and sponsors of trials.
7. Support in developing and implementing policies, guidelines and procedures for the management of medicines and investigational medicinal products across the Trust.
8. Be a primary point of contact for research delivery teams and provide specialist advice and input on all aspects of clinical trials to R&I, Investigators, and research teams.
9. Be a primary point of contact for sponsors (commercial and non-commercial) and contract research organisations (CROs) from pre-site selection to close-out.
10. Provide support and be a point of escalation for Clinical Trials Pharmacy Technician / practitioner staff and assistants.
11. Review, interpret and critically review clinical trial protocols, investigator brochures, pharmacy manuals and other associated documentation incorporating further comment from appropriate specialist clinical and technical colleagues with respect to the capacity and capability assessment of the safe and effective running of clinical trials.
12. Feedback any points of concern identified during trial review to the clinical trial pharmacy service leads, Principal Investigators, and delivery teams as appropriate, and work to identify and deliver solutions to ensure safe and effective clinical trial delivery.
13. Awareness of Advance Gene therapies and design of trials for investigational advanced therapy medicinal products (ATMPs) and how they can be addressed.
14. Understand the roles and responsibilities, governance and sources of support for ATMP clinical trials.
15. Participate in the ongoing research, development, and evaluation of any new ATMPs and Genomics work streams and report findings at a local, regional, and national level.
16. Develop and maintain capacity plans and annual reviews of Performance Indicators. Prepare reports on workload and proposals for future needs, so that they can be fed into the departmental and hospital plans.
17. To work closely with the Clinical Trials Unit and R&I Department to negotiate with clinical trial sponsors (e.g. pharmaceutical companies, charities, academia, networks) to ensure charging is appropriate for all clinical trials and that fees are collected in a timely manner.
18. To provide information and advice to Pharmacy Heads of Services on the potential clinical risk and cost implications of clinical trials and the impact after the trials have been completed, often when information is incomplete or lacking.
19. To comply with legal and other requirements related to the purchase, receipt, supply, safe custody and destruction of drugs and IMP, and maintain accurate and appropriate records.
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