Specialist Pharmacist Clinical Trials

at  University Hospitals Plymouth NHS Trust

PRIMARY DUTIES & AREAS OF RESPONSIBILITY 1. To assist the Advanced Specialist Pharmacist Clinical Trials in ensuring that the documentation, processes and procedures for the handling of IMPs within the pharmacy department meet the relevant current UK and European legislation, ICH GCP guidelines and GMP principles required by the Medicines and Healthcare Regulatory Authority (MHRA), National Patient Safety Alerting System (NPSAS), Regional Pharmaceutical Quality Assurance Services and relevant clinical trial sponsors. 2. To assist in co-ordinating the pharmaceutical input into the setting-up, design and running of clinical trials at the UHPNT.
This will involve close liaison with pharmacy, nursing, and medical staff and R&D department. 3. To act as the deputy to the lead pharmacist for the provision of IMPs for all active clinical trials. 4.
To support in the critical review of clinical trial protocols on their impact on pharmacy, e.g. packaging, labelling and documentation, incorporating further comments from appropriate specialist clinical and production services pharmacists where required. 5. To assist the Pharmacy Clinical Trials Team in producing and checking costings for clinical trials where necessary.
6. To assist with the raising, completion and implementation of all relevant IMP and NIMP documents, controlled procedures, feasibility assessments, prescriptions, dispensing procedures, accountability logs, and stock management records. 7. To ensure appropriate use of IMPs within the pharmacy and support in the production and maintenance of dispensing procedures for all CTIMPs.
8. To provide written instructions and training for pharmacy staff on how to dispense, label, check, handle the IMPs, and perform code-breaks. 9. To assist with training and accreditation of pharmacy staff for clinical trials.
10. To liaise with the pharmacy clinical trials team to assess the impact of substantial amendments on local trial documentation. 11. To 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. To supervise the initial check and preparation of IMPs and NIMPs for all active clinical trials. To undertake 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.
To support the pharmacy investigations into study issues and incidents involving IMP, ensuring appropriate documentation and completion of any actions. 14. To maintain a good working relationship with sponsors, monitors, the R&D department, auditors and regulatory authorities. 15.
To ensure that the confidentiality and security of information and data about study subjects and clinical trial studies are maintained and respected. 16. To undertake and maintain a record of personal Continuing Professional Development (CPD). 17.
To ensure medicines are prescribed and administered in line with local and national policies, and within the legal framework. 18. To provide day-to-day supervision and support to the pharmacy clinical trials staff and rotational pharmacists working in the Pharmacy Clinical Trials. 19.
To 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. To 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.
To ensure that safe and effective systems of work are followed within the unit in compliance with the COSHH (1988) Regulations. 22. To undertake audits and engage with Quality Improvement and practice research projects. Education and Training 23.
Design and participate in training programmes for pharmacy, medical and nursing staff, where necessary. 24. Technical supervision and mentoring of other members of ward-based staff, including pharmacists, technicians, pharmacy support assistants and undergraduate students. 25.
Provide competency based assessment of junior pharmacists, trainee pharmacists and pharmacy technicians and pharmacy support assistants using work-based assessment tools. 26. Train trainee pharmacists in aspects of technical and clinical pharmacy practice to meet the General Pharmaceutical Councils competency requirements, acting as an accredited educational supervisor if required

Please refer the Job description for details