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Detailed job description and main responsibilities

Please read the attached Job Description & Person Specification before applying for this post.

Personal

1. To work as the clinical pharmacist responsible for the pharmaceutical elements of assigned clinical trials involving the use of a medicinal product, ensuring compliance with national guidelines and statutory obligations.
2. To screen, assist with the accurate dispensing and check clinical trials prescriptions to ensure compliance with the particular study protocol.
3. To counsel patients regarding their medication, in accordance with the particular study protocol.
4. To assist in the evaluation, review, set-up and management of Clinical Trials involving investigational medicinal products.
5. To assist the Lead Pharmacist – Clinical Trials in the management and future development of pharmacy clinical trials service. With particular reference to the expansion of the commercial research portfolio.
6. To deputise for the Lead Pharmacist – Clinical Trials.
7. To ensure the continued safe and effective delivery of the pharmacy clinical trials service in order to demonstrate the requirements of Good Clinical Practice (GCP). 
8. To monitor the conduct and working practices in the delivery of clinical trials to ensure GCP and MHRA requirements are met, investigate any deficiencies and consider any corrective actions required.
9. To ensure compliance with the requirements of Good Manufacturing Practice (GMP) as they apply to clinical trials. Ensuring that all clinical trial medicine supplies comply with the national standards of Good Manufacturing Practice.
10. To attend regular meetings and provide advice on pharmaceutical issues relating to clinical trials.
11. To utilise your pharmaceutical knowledge to assess the feasibility and impact of new clinical trials. To consider the clinical impact of trials protocols, how they might affect established clinical pathways or interact with established treatment regimes.
12. To liaise with specialist pharmacists and other healthcare professionals. To obtain their expert input regarding current and future standards of care, in order to ensure a rounded understanding of the disease state being treated and the impact of a trial to the patients and the organisation.
13. To review clinical trial protocols and advise on the pharmaceutical aspects of trial conduct, in line with European Directives and national legislation.
14. To identify and discuss pharmaceutical requirements of individual clinical trials with investigators, their clinical trials teams, R&D department and sponsor companies.
15. To provide expert advice to the Trust’s R&D Department and Principal Investigators in respect of all aspects of IMP manufacture, manipulation, procurement, use and of adherence to associated legislation.
16. To ensure the R&D department are aware of clinical use, manipulation and handling requirements of IMPs and their comparators; and thereby understand the pharmaceutical and clinical impact of any clinical trial.
17. To prepare and validate documentation and processes using the Q-Pulse Document management system. To maintain, develop and approve standard operating procedures and policies.
18. To take an active role in the training of clinical trials staff. And to train the wider pharmacy department in clinical trials related matters.
19. To actively engage with other staff including pharmacists, trainee pharmacists, technicians, student technicians and pharmacy support workers in the dissemination of information about current and upcoming clinical trials.
20. To ensure that all pharmacy staff are trained on the requirements of individual clinical trials with respect to dispensing and checking procedures, to ensure accuracy in the dispensing of clinical trials supplies.
21. To act as an expert source of information on clinical trials related issues and individual clinical trials, both to pharmacy colleagues and research staff.
22. To participate in service audit.
23. To attend regional peer review meetings and assess local application of recognised good practice.

General Service Provision

24. Provide professional and legal clinical supervision in the dispensary to ensure efficient safe systems of work.
25. Undertake a clinical pharmacy commitment to assigned ward(s). This will involve making highly complex clinical interventions and will be in line with the clinical pharmacy service objectives.
26. Provide advice to nursing and medical staff regarding all aspects of medication use and administration.
27. Regularly record clinical interventions and activities in line with departmental policy.
28. Assist in the training of trainee pharmacists and rotational pharmacists to promote continuing professional development.
29. Participate in the in-house Clinical Pharmacy training programme, attend courses, study days etc. as are considered relevant and take an active part in the educational activities of the Pharmacy Department.
30. Participate in the departmental staff appraisal programme, identifying development and training needs and monitoring continuing professional development as per departmental policy and national guidelines from the General Pharmaceutical Council.
31. Represent the Pharmacy department at appropriate Trust meetings.
32. Participate in the weekend / Bank Holiday / lates and on-call rota.