Job summary

The post holder will provide advice to Clinical Trials Aseptics Unit staff on matters relating to research activities (Clinical Trials) in the dispensaries specifically on risk assessment and impact of the research on the dispensary.

They will be responsible for the set-up and supervising the running of the Clinical Trials, Dispensary and Aseptics unit within the dispensary, monitoring quality and effectiveness.

Main duties of the job

Act as role model for Pharmacy Technicians and assistants. Implement current procedures pertaining to personal/departmental/data security. Ensure that good communication regarding operational issues and changes in working practices are maintained. Ensure that all staff adhere to Trust policies/Health & Safety and COSHH regulations. Adhere to the Department's Minimum Standards for Pharmacy Services and other National or Local Standards currently in force. Ensure the live stock control system is managed and maintained in collaboration with the pharmacy IT dept. Maintain all work and rest areas in a clean and tidy state in common with all members of staff.

About us

Royal Berkshire NHS Foundation Trust is one of the largest general hospital foundation trusts in the country and the main provider of acute and specialist care services for West Berkshire. With seven sites, the Trust employs approximately 6,500 staff and serves a population of around 1,000,000 people.

In January 2020, the Trust was rated 'Good' overall by the CQC and was proud to receive the inspection report, which highlighted many examples of good and outstanding care across the Trust. Reflecting the high standards of care on offer, recent patient surveys show that over 90 per cent of patients rate their overall experience of services as excellent, very good or good.

We provide acute medical and surgical services to Reading, Wokingham and West Berkshire and specialist services such as cancer, dialysis and eye surgery to a wider population across Berkshire and its borders.

We are a team of five comprising of 2 pharmacists, 2 pharmacy technicians and 1 research coordinator.

Job description

Job responsibilities

Clinical and Technical

Provide specialised Clinical and Technical advice where appropriate. Provide guidance to junior staff in all technical aspects of dispensing. Ensure all medicinal products are correctly labeled & safely stored in the appropriate environment. Contribute to the maintenance of up to date Departmental Standard Operating Procedure (SOPs) for the use of all equipment in the dispensaries. Supervise and accurately prepare medicinal products as required, in accordance with SOPs, Good Manufacturing Practice (GMP), Good Dispensing Practice (GDP) and Good Clinical Practice (GCP). Supervise and perform dispensing activities, according to SOPs and, for Investigational Medical Products, in accordance with Clinical Trial protocols. Maintain, monitor and archive full documentation regarding the dispensing and costing of the service for both internal and external customers and as required by Good Clinical Practice (GCP) for Clinical trials. Liaise with service users regarding their requirements for dispensing. Plan the weekly workload with the dispensary Manager, Deputy Manager and Pharmacists. Ensure all stocks and dispensed products are appropriately labeled and the correct labels are available for Investigational Medical Products to comply with Annex 13. Ensure all stocks and dispensed products are correctly stored taking into account any physical & legal requirements.

Dispensing

Participate in the accurate, efficient dispensing of prescriptions as required by the service. Dispense in-patient non-ward stock supplies including distribution of drugs to wards and peripheral hospitals. Dispense out-patient prescriptions and counsel patients as instructed. Check prescriptions and query where applicable. Enforce formulary compliance. Assist in the maintenance and checking of dispensary stock and share responsibility for replenishment of stock. Supervise and participate in the dispensing, reconstitution and preparation of Clinical Trial drugs, which may include cytotoxic drugs for Berkshire Cancer Centre patients. Participate in extended roles for technicians as the opportunity arises such as Accredited Technician Checking and other clinical roles subject to availability of suitable training.

Teaching, Training & Research

Assist in planning training schedules for staff new to the dispensaries. Train all grades of staff in dispensing, ensure all accredited techniques and validations are maintained for all members of staff. Train all grades of staff in the dispensaries in Good Clinical Practice (GCP) with relation to their job role. Train all grades of staff in the research activities (Clinical Trials) within the dispensaries. Gain NVQ assessor status, subject to availability of suitable training, and perform assessment of competency/mentor/expert witness for the NVQ2 & NVQ3 Pharmacy Service Award, and also Customer Care NVQ Awards that relate to staff working in the dispensaries. Participate in the Trusts Individual Performance and Development System in accordance with departmental guidelines and timetables. Undertake work, study days, reading and self directed study as a means of personal development, especially toward the organisational needs of the post. Assist the dispensary Manager and Deputy Manager in the setting, reviewing and monitoring of quality standards and organising audits to improve efficiency for the dispensary. Develop new systems of work as required by service developments.

Research Specific work (Clinical Trials)

Obtain Good Clinical Practice (GCP) Training. Work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and the EU Directives relating to Clinical Trials and the Research Governance Framework. Review all Clinical Trial protocols which will involve the dispensary prior to Trust Research & Innovation(R&I) Approval. Participate in confidential communication with the Clinical Trials Pharmacist, Investigators, Research Nurses, Trust R&I, Sponsors, Pharmaceutical Company Clinical Research Associates, Pharmacy Aseptic Services Unit (PASU), dispensary staff and the Clinical Trials PASU Technician during the Pharmacy Approval process, the setting up of new studies and during the running of the study.

Develop, implement and maintain clear and accurate written SOPs for dispensing for each clinical trial in the dispensaries in accordance with Good Clinical Practice (GCP) and each studys protocol.

Ensure Clinical Trial protocols are followed during dispensing of Clinical Trial Investigational Medical Products and other drugs included in the protocol. Maintain and setup systems to reclaim any reimbursement of free or discounted stock of Investigational Medical Product used in Clinical Trials within the dispensaries. Maintain Clinical Trial filing systems. Design drug accountability documentation and prescriptions for Clinical Trials, if required. Work in line with R&I objectives/strategy

Role

Act as role model for Pharmacy Technicians and assistants. Implement current procedures pertaining to personal/departmental/data security. Ensure that good communication regarding operational issues and changes in working practices are maintained. Ensure that all staff adhere to Trust policies/Health & Safety and COSHH regulations. Adhere to the Department's Minimum Standards for Pharmacy Services and other National or Local Standards currently in force. Ensure the live stock control system is managed and maintained in collaboration with the pharmacy IT dept. Maintain all work and rest areas in a clean and tidy state in common with all members of staff.

Establish and manage a process for monitoring Pharmaceutical aspects of Clinical Trials in the dispensaries.

Develop, organise and maintain the Pharmacy Clinical Trials Services in the dispensaries, in conjunction with the Clinical Trials Pharmacist, ensuring compliance with Good Clinical Practice (GCP) guidelines, the Research Governance Framework, the Clinical Trials Directive, the Medicines for Human Use (Clinical Trial) Regulations 2004 and other relevant guidelines, regulations and policies.

Manage the process of purchasing, ordering, receipt, storage, dispensing, return and disposal of Clinical Trial drugs within the dispensaries and maintain stock levels. Manage and maintain the database to monitor patients activity in non-commercially Sponsored Clinical Trials within the dispensaries.

Manage and maintain the database of the training of the dispensary staff undertaking Clinical trial work.

Person Specification

Qualifications and experience

Essential

presentation years of experience

Desirable

confidence knowledge of the role

Attention to detail

Essential

Application matches job desciption

Desirable

how they fit in with the team

presentation

Essential

Appearance

Desirable

previous knowledge or skill on the job