Clinical Trials Pharmacist Specialist

Job Summary

An exciting opportunity has arisen for a dedicated pharmacist post to lead, manage and deliver the pharmacy service for clinical trials at Nottingham University Hospitals NHS Trust. Your focus will be on a wide range of clinical specialities, working as part of the established pharmacy clinical service and technician-supported clinical trials teams and in close liaison with the clinicians and research teams.

Main Duties of the Job

To be the pharmacy lead for clinical trials of medicinal products conducted in a variety of clinical divisions excluding cancer. To be responsible for appraisal of clinical trials of medicinal products and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) advanced therapy investigational products (ATIMPs) and non-investigational medicinal products (NIMPs).

About Us

With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.

Key Responsibilities

• Takes responsibility for the delivery, management and development of the pharmacy clinical trials service.
• Attends specialty clinical trials meetings as appropriate.
• In co-operation with the Research teams, and the Principal Pharmacist, Research and Innovative Treatments, identifies and prioritises clinical trial pharmacy services to ensure national and local agendas are delivered.
• Develops, implements and audits pharmacy clinical trials practices.
• Provides expert advice regarding trials to the Pharmacy Department, the relevant specialties, consultant teams, research teams and other clinical specialties as required.
• Supports the Chief Pharmacist and Clinical Director of Medicines Optimisation and the Principal Pharmacist, Research and Innovative Treatments in clinical trials management issues and projects.
• Participates and supports the development of business plans and department and clinical strategies, in response to expansion of services, new consultant appointments, national initiatives and locally identified risks.
• Contributes to the overall organisation, administration and management of the Pharmacy Clinical trials team

Clinical Trials Service (80%)

• Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service.
• Works according to GCP guidelines and agreed pharmacy clinical trials procedures.
• Critically appraises clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of the study are deliverable and safe, in liaison with the pharmacy production unit staff as required.
• Calculates pharmacy support costs clinical trials protocols, liaising with the speciality research teams, sponsors and NUH Research and Innovation (R&I) Department where NUH is the chief investigating site.
• Liaises with NUH R&I and research teams, to ensure timely appraisal, costing and pharmacy approval for clinical trials.
• Leads and finalises the set-up of clinical trials, writing and/or checking dispensing procedure, and manufacturing worksheets where applicable.
• Is accountable for adherence to protocol requirements for investigational medicinal product (IMP) management.
• Facilitates the Principal Pharmacist for Research and Innovative services in the development of new services to deliver novel and innovative therapies to patients with the research setting.
• Participates in the provision of a clinical pharmacy service for patients recruited into clinical trials within the Trust.

Clinical Practice (20%)

• Supports the provision, of a high quality, comprehensive specialist pharmacy service.
• Demonstrates professional accountability to patients under their care.
• Provides specialist advice and guidance on all issues relating to prescribing and therapeutics of drugs in line with national and local guidelines.
• Uses specialist knowledge and experience, and appraises information from numerous sources to provide highly specialised advice on drug therapy to medical, nursing and pharmacy staff. This may include advice about experimental medicines or of medicine use where limited evidence exists.
• Assesses and verifies prescription and charts and prescribing, including chemotherapy, in order to ensure safe, rational and effective prescribing within existing guidelines.
• Identifies potential adverse reactions to medicines, drug interactions and Intravenous drug compatibility issues.
• Establishes drug histories and enables the use of patients own medicines.
• Counsels patients on their drug therapy to improve medication usage and patient understanding of their medication during in-patient stay and after discharge.
• Provides medications for individual patients during their stay in hospital and at discharge as necessary.
• Requests and interprets clinical tests and serum drug levels to monitor and make recommendations to improve effectiveness of drug therapy.
• Pro-actively liaises with other members of the multidisciplinary team in order to make recommendations about drug therapy to improve patient outcomes.
• Encourages and monitors adherence to hospital formulary, trial protocols and national guidelines.
• Amends prescriptions on verbal orders from prescribers and transcribes prescriptions for patients being discharged.
• Is accountable on the clinical areas served (wards and clinics) for adherence to all pharmacy policies and procedures relating to medicines management.
• Works with the other pharmacists in the provision of a high quality clinical pharmacy service to wards in the hospital as directed by the Assistant Head of Pharmacy - Clinical Services Lead.
• Provides professional supervision in the dispensary by:
  • Final checking and release of manufactured/dispensed medicines, in accordance with good manufacturing practice and departmental procedures.
  • Accurately interpreting and clinically screening prescriptions, referring to relevant protocols and intervening when necessary.

Financial Resource Management

• Calculates the cost of pharmacy support for clinical trials protocols, liaising with the specialty research teams, sponsors and NUH R&I Department.
• Identifies potential cost savings and/or efficiency initiatives in medicines usage, relevant to clinical trials.
• Ensures trials fees are invoiced and reclaim mechanisms for the medicine costs are accounted for and implemented, liaising with the Specialist Pharmacist High-cost drugs management.

Human Resource Management

• Acts as a role model.
• Supervises and teaches junior staff (rotational and diploma pharmacists, technicians, pre-registration pharmacists, pharmacy students).
• Leads on the submission of business cases to secure funding for service developments/new pharmacy posts within the specialty, in liaison with the team leader.
• Assists in the recruitment of new staff.
• Contributes to the performance and line management of pharmacy staff working within the Clinical trials teams, including appraisals.

Research and Development

• Undertakes, supervises and participates in research, and if suitable registers for a further degree (DPharm, MPhil).
• Actively evaluates and integrates research evidence into practice to develop and improve pharmacy services within the directorate and the department.
• Maintains contact with appropriate national and local specialist groups to facilitate best practice to be identified and incorporated into NUH practice.

Education and Training

• Works with the Principal Pharmacist, Research and Innovative Treatments, and the Education & Training pharmacists to provide and develop a competency framework, training plans and materials on issues relating to Clinical Trials to ensure training facilities for Advanced Specialist Pharmacy Practice Framework are available.
• Delivers teaching to nursing, medical, pharmacy and other AHP staff about medication issues within Clinical Trials and the relevant specialties, as appropriate.
• Provides education, training and assessments for pharmacists on Clinical Diplomas, Pre-Registration Pharmacists, other pharmacy, nursing and medical staff.

General

• Participates in rostered flexible working including evening, weekend and bank holiday arrangements in line with service commitments.
• Participates in the back-up on-call service for shift working pharmacists as required.
• Undertakes any other duties that may reasonably be required as agreed by senior staff.

Freedom to Act

• Makes and is accountable for clinical decisions in the interests of patient safety and clinical outcome within the post holders specialty and sphere of competence.
• Works under own initiative and acts independently within relevant national and local legislation, protocols and guidelines and in accordance with objectives set between the Chief Pharmacist and the Assistant Chief Pharmacist Medicines Finance, Therapeutics and Digital Services.
• Is accountable for own professional actions, working to standards laid down by the General Pharmaceutical council.
• Acts within NUH policy and procedures.
• Acts in accordance with current legislation relating to the use of medicinal products and clinical trials.

---