Job summary
Dueto expansion the of our service an exciting opportunity has arisen for anenthusiastic, self motivated band 8a pharmacist to join the pharmacy ClinicalTrials Management team at Leeds Teaching Hospitals NHS Trust. Applicants shouldhave an active interest in clinical trials and an understanding of goodclinical practice GCP.
Thisis a split post working with Aseptics Services to support their safe deliveryof clinical trials. You will provide senior aseptic services cover as part of awider team, working closely with the team to ensure safe and appropriate supplyof medicines. The option to work as partof the aseptic service support to the radiopharmacy team, with relevantexperience, is available.
Thispost will provide support for clinical trials running at all 3 sites. It is an exciting time to work in research aswork is currently underway on developing two new state of the art hospitalswith plans to create a world class hub for innovation. You will, as part ofyour portfolio, support the growing number of early phase studies and ATIMPs (Advanced Therapy Investigational Medicinal Products) especially for thevaccine portfolio and the Childrens will work closely with a number of internal andexternal teams including clinical pharmacists, aseptic services, the ClinicalResearch Facility team, investigators and research nurses, the Trust Research and Innovation team and pharmaceutical companies
Expected Shortlist date:17/09/24
Planned interview date:25/09/24
Main duties of the job
Themain duties for staff working in this role are
Provide advice and information inrelation to all medicines related aspects of R and I activities, includingclinical trials, within the Trust to ensure compliance with nationallegislation and guidelines.
Review and improve current MedicinesManagement and Pharmacy Services CSU (MMPS) clinical trial set up processes toprovide a service that meets the Trusts performance in initiation and deliverytargets for NIHR portfolio clinical trials.
Provide support and advice toclinical pharmacists in the review of new protocols. Liaise with aseptics,investigators, trial sponsors and Trust R&I regarding medicines managementissues raised as part of the review.
Check and approve final versions ofIMP (investigational medicinal product) management procedures for each trial.Perform the Pharmacy Green Light process for Clinical Trials.
To support Aseptics Services with theset up and ongoing management of Clinical Trials. Providing the senior linkbetween pharmacy clinical trials and aseptics services. Coordinating workloadand approving trial specific worksheets
Assist the Clinical Trials team inpreparing for clinical trial audits and inspections by trial sponsors,pharmaceutical companies and regulatory agencies.
Assist in the provision of trainingto pharmacy staff on GCP and regulatory frameworks, guidelines, policies andprocedures relating to clinical trials.
About us
LeedsTeaching Hospitals NHS Trust is one of the largest teaching hospitals in the UKwith a large number of specialised and highly specialised services. It has an established reputation as a Centreof Excellence for delivering high quality research and innovation on a largescale with pharmacy currently supporting over 350 clinical trials across allhospital sites.
Leedsis a wonderful city to work in and LTHT is an organisation that puts itspatients first and highly values and supports its staff. Pharmacy is a forwardthinking department that values the contribution of all our staff and isrecognised in the organisation for our collaborative working as we continuouslysupport our workforce to develop to their potential in delivering the bestpatient care.
Leeds Teaching Hospitals is committed to our processof redeploying at risk members of our existing workforce to new roles. Assuch, all our job adverts are subject to this policy and we reserve the rightto close, delay or remove adverts while this process is completed. If you doexperience a delay in the shortlisting stage of the recruitment cycle, pleasebear with us while this process is completed, and contact the named contact ifyou have any questions.
Job description
Job responsibilities
2. JOB PURPOSE
To lead, deliver, develop and evaluate highly specialised clinical pharmacy services to a clinical speciality within the Trust
3. JOB DIMENSIONS
Leads the highly specialised clinical pharmacy service to patients and the multidisciplinary team within a given clinical speciality. Ensures medicines are used appropriately, safely, and cost effectively in accordance with Trust policy, standard operating procedures and medicine legislation. The post holder is expected to determine how the outcomes are best achieved in specific circumstances.
Manage other pharmacists providing specialised clinical pharmacy service within own clinical speciality depending on size of area.
Works directly and regularly with consultants, senior nursing staff and managers within the clinical speciality. Monitors and interprets expenditure on medicines within own clinical speciality. Provides the Directorate with regular reports to assist in the safe use of medicines, the management of the drug budget and clinical governance issues. The report also includes risk management such as the recording of significant clinical interventions and near misses.
Supervise, along with other members of their multidisciplinary team, the development and implementation of treatment protocols, and guidelines for use of drugs within the clinical area.
Responsible for training pharmacists, and other health care professionals, on aspects of drug use within the clinical area.
Provides minimum of at least one 4 hour session of service cover in the dispensary or aseptic dispensary each week. Participates in evening, weekend and bank holiday rota and where appropriate, out of hours services.
To act as the Responsible Pharmacist in line with local procedures.
SPECIFIC DUTIES FOR CLINICAL TRIALS
Provide advice and information in relation to all medicines related aspects of R and I activities, including clinical trials, within the Trust to ensure compliance with national legislation and guidelines.
Review and improve current Medicines Management and Pharmacy Services CSU MMPS clinical trial set up processes to provide a service that meets the Trusts performance in initiation and delivery targets for NIHR portfolio clinical trials.
Provide support and advice to ACPs and rotational pharmacists in the review of new protocols. Liaise with aseptics, investigators, trial sponsors and Trust R&I regarding medicines management issues raised as part of the review.
Check and approve final versions of IMP (investigational medicinal product) management procedures for each trial. Perform the Pharmacy Green Light process for Clinical Trials
Ensure that current Pharmacy Clinical Trial Standard Operating Procedures (SOPs) are applicable and comply with Good Clinical Practice and the requirements of the UK Clinical Trial Regulations. Write, update or amend in conjunction with the Clinical Trials Management Team as necessary
Assist the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies and regulatory agencies.
Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies and procedures relating to clinical trials.
Line manage Band 7 pharmacists working within the Clinical Trials team.
Contribute to service development and quality improvement strategies in line with the Leeds Improvement Method.
Use local and national networking opportunities to promote the LTHT clinical trials service to a wider audience.
To provide cover for Trust R&I governance, education and prioritisation meetings and have close liaison with the clinical research teams.
SPECIFIC DUTIES FOR ASEPTIC SERVICES
To provide professional supervision and release of products in Aseptic and radiopharmacy dispensaries
To support the Aseptic Service Manager in the delivery, management and development of the pharmacy Aseptic Dispensing service across the Trust, ensuring that legislative and statutory controls are met and that the service supports high quality patient care through cost effective and responsive aseptic dispensing units
To be responsible for induction and training in matters related to Parenteral Therapy to both pharmacy staff and other health care professionals as required.
To provide pharmaceutical care to patients in defined clinical areas
Other
Provide a service commitment, typically a four hour session to a specific area within the pharmacy department dispensary, aseptics or medicines information
Perform other duties as directed by manager
Participate in the weekend service and where contracted, the emergency duty service
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED
Masters qualification in Pharmacy (4 years) or equivalent qualification plus one year pre-registration experience
Registrant of the General Pharmaceutical Council (GPhC)
Postgraduate diploma in Clinical Pharmacy or equivalent experience or qualification
Non medical prescriber status is preferred.
Substantial post registration experience as a practising clinical pharmacist. Ability to demonstrate foundation level competencies in all 6 domains of the Advanced to Consultant Level Framework (ACLF)
Experience of dealing with highly complex clinical issues which require the pharmacist to analyse information from a range of sources, which may not be in agreement, to formulate a response. In such situations, it may be necessary to find a novel solution to an unusual clinical situation. The pharmacist will have developed negotiating and persuasive skills with other clinical team members, patients and relatives
Experience of dealing with a wide variety and grade of hospital staff (including senior medical and managerial staff) on a regular and ongoing basis
Specialist knowledge of clinical area/department which demonstrates ability to manage a caseload, preferably within the clinical speciality
Considerable experience in hospital pharmacy and aseptic dispensing/processing
Specialist knowledge of and training in Aseptic Dispensing and Quality Assurance
CORE BEHAVIOURS AND SKILLS
Leadership
Interpretation of financial information
Team player
Enthusiastic
Lateral thinker
Excellent communication - oral/written/listening
Good problem solver
Good time management skills
Adaptable
Able to use initiative
Highly developed negotiation and influencing skills
Meticulous attention to detail
The individual will organise their own work and potentially that of others in the specialist service on an on going basis training, audit, project work, attendance of meetings, own ward cover etc
Person Specification
Qualifications
Essential
1. Post graduate diploma in clinical pharmacy
Desirable
2. Good Clinical Practice Training
Skills & behaviours
Essential
3. Team player
4. Prioritisation and Time management
5. Meticulous attention to detail
6. Able to work under own initiative
7. Excellent influencing and negotiating skills
Desirable
8. Mentoring skills
Experience
Essential
9. Knowledge and application of good clinical practice
10. Knowledge and application of good manufacturing practice and quality assurance
11. Foundation level competency in all Advanced Pharmacy Framework (APF) domains
Desirable
12. Experience in radiopharmacy