Specialist Pharmacist Clinical Trials Expert

Job Summary

We are seeking a highly motivated and experienced pharmacist to join our Clinical Trials team as a Specialist Pharmacist Clinical Trials. This is an exciting opportunity for a pharmacist to develop their skills and expertise in clinical trials, working closely with our dedicated team to support the Trust's growing portfolio of clinical research.

Main Duties and Responsibilities

1. Assist the Advanced Specialist Pharmacist Clinical Trials in ensuring that the documentation, processes, and procedures for the handling of Investigational Medicinal Products (IMPs) meet the relevant current UK and European legislation, ICH GCP guidelines, and GMP principles.
2. Coordinate the pharmaceutical input into the setting-up, design, and running of clinical trials at the University Hospitals Plymouth NHS Trust (UHPNT), involving close liaison with pharmacy, nursing, and medical staff and the R&D department.
3. Act as the deputy to the lead pharmacist for the provision of IMPs for all active clinical trials.
4. Support the critical review of clinical trial protocols on their impact on pharmacy, packaging, labeling, and documentation, incorporating further comments from appropriate specialist clinical and production services pharmacists where required.
5. Assist the Pharmacy Clinical Trials Team in producing and checking costings for clinical trials where necessary.
6. Raise, complete, and implement all relevant IMP and Non-IMPs documents, controlled procedures, feasibility assessments, prescriptions, dispensing procedures, accountability logs, and stock management records.
7. Ensure the appropriate use of IMPs within the pharmacy and support the production and maintenance of dispensing procedures for all CTIMPs.
8. Provide written instructions and training for pharmacy staff on how to dispense, label, check, handle the IMPs, and perform code-breaks.
9. Assist with training and accreditation of pharmacy staff for clinical trials.
10. Liaise with the pharmacy clinical trials team to assess the impact of substantial amendments on local trial documentation.
11. Accurately screen, dispense, check prescriptions, and counsel patients regarding their medication as required in accordance with the particular study protocol, chemotherapy prescriptions produced on both the electronic prescribing system and paper templates.
12. Supervise the initial check and preparation of IMPs and NIMPs for all active clinical trials, undertaking the final check for these products made under section 37 exemption of the Medicines for Human Use (Clinical Trials) Regulation 2004, taking responsibility for the final release of medicinal products to patients, including Intrathecal products.
13. Support the pharmacy investigations into study issues and incidents involving IMP, ensuring appropriate documentation and completion of any actions.
14. Maintain a good working relationship with sponsors, monitors, the R&D department, auditors, and regulatory authorities.
15. Ensure the confidentiality and security of information and data about study subjects and clinical trial studies are maintained and respected.
16. Undertake and maintain a record of personal Continuing Professional Development (CPD).
17. Ensure medicines are prescribed and administered in line with local and national policies, and within the legal framework.
18. Provide day-to-day supervision and support to the pharmacy clinical trials staff and rotational pharmacists working in the Pharmacy Clinical Trials.
19. Coordinate with the Clinical Trials Specialist Assistant Technical Officer the daily workload of injectable IMPs and NIMPs to the wards and departments, taking clinical priority and the capacity plan for the unit into account.
20. Be on the Trust register for the release of intrathecal chemotherapy from the pharmacy department, according to relevant Department of Health guidelines and local Trust policy.
21. Ensure safe and effective systems of work are followed within the unit, in compliance with the COSHH (1988) Regulations.
22. Undertake audits and engage with Quality Improvement and practice research projects.

Education and Training

1. Design and participate in training programmes for pharmacy, medical, and nursing staff, where necessary.
2. Provide technical supervision and mentoring of other members of ward-based staff, including pharmacists, technicians, pharmacy support assistants, and undergraduate students.
3. Provide competency-based assessment of junior pharmacists, trainee pharmacists, and pharmacy technicians and pharmacy support assistants using work-based assessment tools.
4. Train trainee pharmacists in aspects of technical and clinical pharmacy practice to meet the General Pharmaceutical Council's competency requirements, acting as an accredited educational supervisor if required.

Leadership and Management

1. Directly manage a band 6 pharmacist if required, including undertaking annual achievement reviews and monthly 1:1 meetings.
2. Assist the Advanced Specialist Pharmacists Clinical Trials in planning and implementing change management projects.
3. Assist the Advanced Specialist Pharmacists Clinical Trials in investigating any medicine/pharmaceutical-related incidents or complaints and devising ways of minimizing risk of future re-occurrence.
4. Assist the Advanced Specialist Pharmacists Clinical Trials in implementing national guidance, recommendations, and statutory requirements locally.
5. Assist in the development and maintenance of protocols and procedures in relation to pharmacy services and medicines management, including Patient Group Directions.

Research and Evaluation

1. Undertake and participate in internal and external audits and drug use evaluations within the remit of the pharmacy aseptic service and pharmacy clinical trials, feeding back audit results and implementing audit action plans, reporting to relevant service lines.
2. Participate in research and development, including clinical trials.

Core Pharmacy Functions

1. Participate as necessary in the on-call, weekends, Bank Holiday, and emergency duty/on-call rotas for Aseptic Services, noting the intention to move to a 7-day service, when core duties will be distributed across a full week.
2. Clinical pharmacy services may develop to include a shift pattern or working.
3. Register and practice as a pharmacist Non-medical Prescriber (or must be willing to undertake the non-medical prescribing qualification when requested), as dictated by the needs of the service.

General Responsibilities

1. Contribute to the provision of pharmacy services across the department as appropriate.
2. Provide regular reports on and plans to develop the services provided as part of the business planning and clinical governance process.
3. Assist in the processing of high-cost drugs and homecare medicines within speciality.
4. Participate in the late duty, on-call, weekend, and bank holiday rotas.
5. Implement and contribute to Trust-wide administrative, personnel, and professional policies, where appropriate.
6. Assist other professions in maintaining current awareness in the clinical use of medicines.
7. Take responsibility for own learning and development by recognizing and taking advantage of all opportunities to learn, including full participation in the appraisal system, and by maintaining a professional/personal portfolio of learning, aligning with the Royal Pharmaceutical Society's Competency Framework.
8. Comply with the requirements of relevant legislation and guidelines on professional good conduct.
9. Undertake any other duties as requested by your line manager.

---