We are very excited to be seeking enthusiastic, motivated and dynamic pharmacists who would keen to take the next step in their career development and specialise in clinical trials.
This post provides an opportunity for the post holder to enjoy comprehensive training and to develop their skills in all aspects of clinical trials with learning outcomes and training and education opportunities linked to the Royal Pharmaceutical Society Frameworks.
This role will allow the post holder to develop a portfolio suitable for either specialist roles with clinical trials or progression to Band 8a advanced specialist pharmacist roles.
You will be part of the Pharmacy Departments well-established and dedicated Clinical Trials team supporting the Trusts' growing portfolio of clinical research across all clinical specialties. With a particular focus on oncology and haematology studies, from phase 1 to phase 4. The Trust has also been in the forefront for COVID 19 Vaccine studies and in the future is looking to grow its portfolio of Phase 1 studies within our Clinical Research Facility.
For an informal discussion or to arrange a site visit please contact Lai Fai (Ruth) Mak, Advanced Specialist Pharmacist Clinical Trials .
Main duties of the job
You will be involved in the checking and releasing of aseptically prepared products to ensure that products are prepared in accordance with the principles of good manufacturing practice (GMP), and when applicable Good Clinical Practice (GCP) and as per trial protocols and relevant study materials.
The post holder will comply with the current and relevant national legislation, regulations, and guidelines such as the UK Policy Framework for Health and Social Research (2020) and International Conference of Harmonisation Good Clinical Practice guideline (ICH GCP) in the conduct of clinical research.
Participate in the Aseptic Services on-call and out of hours service on a rotational basis.
Undertake teaching and clinical supervision of pharmacy staff and other healthcare employees.
Undertake audits and engage with Quality Improvement and practice research projects.
Work with and support senior pharmacists, clinical and governance teams to develop guidelines and protocols and within clinical trials
*Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.*
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment team on . We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job responsibilitiesPRIMARY 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.
Person SpecificationQualifications
- Master's Degree (or equivalent) in Pharmacy.
- Current registration with the General Pharmaceutical Council
- Master's degree in oncology / haematology, or Pharmaceutical Technology and Quality Assurance
- Management training
- ICH GCP training
- Member of the United Kingdom Clinical Pharmacy Association (UKCPA)
- Postgraduate diploma in clinical pharmacy in progress or completed
- Member of the Royal Pharmaceutical Society
Aptitude and Abilities
- Good communication skills, written and verbal, with ability to demonstrate fluency, clarity and effectiveness at all levels
- Demonstrate potential management ability
- Proven knowledge and understanding of financial issues
Knowledge
- Relevant demonstrable post-registration experience as a pharmacist in UK and broad proven knowledge base of clinical areas
- Demonstrable experience in a range of clinical specialties.
- Excellent proven knowledge of general clinical pharmacy and drug use.
- Excellent written and oral communication skills and able to communicate effectively with clinical staff, patients and relatives.
- Proven understanding of NHS priorities.
- Good proven understanding of the clinical research process including Good Clinical Practice and research governance
- Demonstrable experience of working in a clinical trials environment
- Completed clinical rotations in Medicine, Surgery, Medicines Information, Aseptics, and Cancer Services
- Specialised proven knowledge of drug use within oncology / haematology
- Previous demonstrable experience in a manufacturing environment to include proven knowledge of non-sterile preparation, prepacking/ assembly, and aseptic preparation/manufacturing.
- Good proven knowledge of 'A Guide to Good Manufacturing Practise' and 'Aseptic Dispensing for NHS Patients'
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Advanced Specialist Pharmacist Clinical Trials
£47,810 to £54,710 a yearPer Annum pro rata
