Adv Clinical Pharmacist - Clinical Trials
Due to the expansion of our service, an exciting opportunity has arisen for an enthusiastic, self-motivated band 8a pharmacist to join the pharmacy Clinical Trials Management team at Leeds Teaching Hospitals NHS Trust. Applicants should have an active interest in clinical trials and an understanding of good clinical practice (GCP).
This is a split post working with Aseptics Services to support their safe delivery of clinical trials. You will provide senior aseptic services cover as part of a wider team, working closely with the team to ensure safe and appropriate supply of medicines. The option to work as part of the aseptic service support to the radiopharmacy team, with relevant experience, is available.
This post will provide support for clinical trials running at all 3 sites. It is an exciting time to work in research as work is currently underway on developing two new state-of-the-art hospitals with plans to create a world-class hub for innovation. You will, as part of your portfolio, support the growing number of early phase studies and ATIMPs (Advanced Therapy Investigational Medicinal Products) especially for the vaccine portfolio and the Children's Hospital. You will work closely with a number of internal and external teams including clinical pharmacists, aseptic services, the Clinical Research Facility team, investigators and research nurses, the Trust Research and Innovation team and pharmaceutical companies.
Planned interview date: 25/09/24
Main duties of the job
1. 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.
2. Review and improve current Medicines Management and Pharmacy Services CSU (MMPS) clinical trial set up processes to provide a service that meets the Trust's performance in initiation and delivery targets for NIHR portfolio clinical trials.
3. Provide support and advice to clinical 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.
4. Check and approve final versions of IMP (investigational medicinal product) management procedures for each trial. Perform the Pharmacy Green Light process for Clinical Trials.
5. To support Aseptics Services with the setup and ongoing management of Clinical Trials. Providing the senior link between pharmacy clinical trials and aseptics services. Coordinating workload and approving trial-specific worksheets.
6. Assist the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies, and regulatory agencies.
7. Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies, and procedures relating to clinical trials.
About us
Leeds Teaching Hospitals NHS Trust is one of the largest teaching hospitals in the UK with a large number of specialised and highly specialised services. It has an established reputation as a Centre of Excellence for delivering high-quality research and innovation on a large scale with pharmacy currently supporting over 350 clinical trials across all hospital sites.
Leeds is a wonderful city to work in and LTHT is an organisation that puts its patients first and highly values and supports its staff. Pharmacy is a forward-thinking department that values the contribution of all our staff and is recognised in the organisation for our collaborative working as we continuously support our workforce to develop to their potential in delivering the best patient care.
Leeds Teaching Hospitals is committed to our process of redeploying at-risk members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.
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.
1. Manage other pharmacists providing specialised clinical pharmacy service within own clinical speciality depending on the size of the area.
2. 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.
3. Supervise, along with other members of their multidisciplinary team, the development and implementation of treatment protocols, and guidelines for the use of drugs within the clinical area.
4. Responsible for training pharmacists, and other health care professionals, on aspects of drug use within the clinical area.
5. Provides a 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.
6. To act as the Responsible Pharmacist in line with local procedures.
SPECIFIC DUTIES FOR CLINICAL TRIALS
1. 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.
2. Review and improve current Medicines Management and Pharmacy Services CSU MMPS clinical trial setup processes to provide a service that meets the Trust's performance in initiation and delivery targets for NIHR portfolio clinical trials.
3. 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.
4. Check and approve final versions of IMP (investigational medicinal product) management procedures for each trial. Perform the Pharmacy Green Light process for Clinical Trials.
5. 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.
6. Assist the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies, and regulatory agencies.
7. Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies, and procedures relating to clinical trials.
8. Line manage Band 7 pharmacists working within the Clinical Trials team.
9. Contribute to service development and quality improvement strategies in line with the Leeds Improvement Method.
10. Use local and national networking opportunities to promote the LTHT clinical trials service to a wider audience.
11. 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
1. To provide professional supervision and release of products in Aseptic and radiopharmacy dispensaries.
2. 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.
3. To be responsible for induction and training in matters related to Parenteral Therapy to both pharmacy staff and other health care professionals as required.
4. To provide pharmaceutical care to patients in defined clinical areas.
Other
1. Provide a service commitment, typically a four-hour session to a specific area within the pharmacy department e.g. dispensary, aseptics or medicines information.
2. Perform other duties as directed by manager.
3. Participate in the weekend service and where contracted, the emergency duty service.
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED
1. Masters qualification in Pharmacy (4 years) or equivalent qualification plus one year pre-registration experience.
2. Registrant of the General Pharmaceutical Council (GPhC).
3. Postgraduate diploma in Clinical Pharmacy or equivalent experience or qualification.
4. Non-medical prescriber status is preferred.
5. 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).
6. 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.
7. Experience of dealing with a wide variety and grade of hospital staff (including senior medical and managerial staff) on a regular and ongoing basis.
8. Specialist knowledge of clinical area/department which demonstrates ability to manage a caseload, preferably within the clinical speciality.
9. Considerable experience in hospital pharmacy and aseptic dispensing/processing.
10. Specialist knowledge of and training in Aseptic Dispensing and Quality Assurance.
CORE BEHAVIOURS AND SKILLS
1. Leadership
2. Interpretation of financial information
3. Team player
4. Lateral thinker
5. Adaptable
6. Able to use initiative
7. Highly developed negotiation and influencing skills
8. Meticulous attention to detail
The individual will organise their own work and potentially that of others in the specialist service on an ongoing basis e.g. training, audit, project work, attendance of meetings, own ward cover etc.
Person Specification
Qualifications
* Postgraduate diploma in clinical pharmacy
* Good Clinical Practice Training
Skills & behaviours
* Team player
* Prioritisation and Time management
* Meticulous attention to detail
* Able to work under own initiative
* Excellent influencing and negotiating skills
Experience
* Knowledge and application of good clinical practice
* Knowledge and application of good manufacturing practice and quality assurance
* Foundation level competency in all Advanced Pharmacy Framework (APF) domains
* Experience in radiopharmacy
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.
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