JOB DESCRIPTION. 1 year fixed term. Division A Pharmacy. University Hospitals Birmingham. Advanced Clinical Pharmacist Trials.

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1 JOB DESCRIPTION JOB TITLE: Pharmacy Technician Haematology Clinical Trials PAY BAND: Agenda for change - Band 5 TERMS AND CONDITIONS DEPARTMENT/DIVISION: BASED AT: REPORTS TO: PROFESSIONALLY RESPONSIBLE TO: 1 year fixed term Division A Pharmacy University Hospitals Birmingham Advanced Clinical Pharmacist Trials Chief Pharmacist LAST UPDATED: 31 st July 2017 JOB PURPOSE: To assist in delivering the Pharmacy Clinical Trials Service to the Trust as part of the Pharmacy Clinical Trials Team with particular emphasis on delivering Haematology clinical trials. KEY RELATIONSHIPS: Senior Pharmacy Technician Cancer Clinical Trials Pharmacy Technician Dispensary Clinical Trials Pharmacists within the Pharmacy Clinical Trials Team Haematology Research Team NIHR/Wellcome Trust Clinical Research Facility Staff Other Research Teams across the Trust Clinical trial personnel from trial sponsors and Clinical Research Organisations Aseptic Production Unit Managers Dispensary Managers Pharmacy QA Staff KEY RESULT AREAS: Day-to-day delivery of the Pharmacy Clinical Trials Service (PCTS) supported by the Pharmacy Clinical Trials Team to ensure the safe and timely aseptic and nonaseptic dispensing of clinical trial medication in accordance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) in: The Pharmacy Clinical Trials Dispensary The Pharmacy Aseptic Unit To assist in the set up of clinical trials in all of the above areas with particular emphasis on haematology trials.

2 To assist in the training of other trials and non-trials staff where necessary. To assist in the delivery of all aspect s of the QA strategy for the Pharmacy Clinical Trials Service. KEY RESPONSIBILITIES: 1. LEADERSHIP AND SERVICE DEVELOPMENT 1.1. To act as a role model for any non-trials staff who may be assisting in any aspect of IMP management for a clinical trial Provide advice, support and training to all pharmacy and research staff in the dispensing, accuracy checking and documentation of clinical trial medicines To actively contribute in the further development of the Pharmacy Clinical Trials Service to consistently improve on efficiency and safety, ensuring adherence to GCP and GMP. 2. AUDIT 2.1. To assist in audits or inspections of clinical trials conducted by R&D and external representatives, such as the MHRA or sponsor organisations To assist in the delivery of the QA strategy for the Pharmacy Clinical Trials Service by: Conducting internal audits of clinical trials being delivered by the Pharmacy Clinical Trials Service to ensure that trial protocols are adhered to at all times and that procedures are conducted according to Trust R&D governance and legislation (MHRA, ICH- GCP, COSHH and European Directive) by provision of the relevant approvals and certificates Conducting internal audits of adherence to Pharmacy Clinical Trial Policies and Procedures, reviewing where appropriate Assisting in investigations and corrective action/preventative actions of errors and incidents involving trial medication Assisting in the environmental monitoring audit strategy for the Pharmacy Aseptic Unit and the Clinical Trials Dispensary Collation and dissemination of workload figures for clinical trials at the end of each month to allow regular audit of workload. 3. CLINICAL & TECHNICAL RESPONSIBILITY 3.1. To assist the Senior Pharmacy Technician Cancer Clinical Trials and Pharmacy Technician - Dispensary Clinical Trials in delivering the Haematology trials, involving dispensing from the Pharmacy Clinical Trials Dispensary and the Pharmacy Aseptic Unit To work alongside the other members of the Pharmacy Clinical Trials Team in delivering other aseptic and dispensary based trials to maintain competency in delivery of all types of clinical trials allowing adequate crosscover at all times To assist the Pharmacy QA Team to ensure the safe delivery of all Dispensary and Aseptic Unit based trials ensuring compliance to all relevant principles and legislation including GCP and GMP.

3 3.4. To assist in the set up and running of haematology clinical trials in conjunction with other members of the Pharmacy Clinical Trials Team, to include: Review of IMP sections of trial protocols to identify and resolve any potential operational issues with the IMP management throughout the study Attend site initiation meetings and liaise with the research teams to discuss each new trial and its requirements Develop clear and concise trial specific dispensing procedures and documentation Design additional medication labels to ensure that all clinical trial medication issued to patients complies with the relevant Trust guidelines and legislation on the dispensing of medicinal products and IMPs Ensure that all required documentation is present and that each pharmacy file is complete before any new trial commences, and ensure regular updates/amendments of documentation as necessary Ensure all trial prescriptions are filed in the relevant trial file at the end of each month Act as one of the key contacts for sponsor representatives for the day-to-day management of clinical trials including arranging monitoring visits Act as one of the key contacts for closedown visits at the end of each trial to ensure accurate reconciliation of all clinical trial medication, completion of all documentation, final archiving of the pharmacy file and where appropriate, full payment of pharmacy fees Have day-to-day responsibility for the IMP management, including IMP ordering, receipt, storage and reconciliation of used IMP against that dispensed, of studies they are leading on and act as cover for other members of the Pharmacy Clinical Trials Team, as needed and appropriate Ensure good stock rotation and removal of trial supplies that are no longer required or have expired and segregation of these supplies from main trial stock Continuous temperature monitoring of the storage environment to ensure that all trial supplies are stored according to the pharmaceutical company s specifications, with investigation and documentation of excursions outside the specified temperature range, quarantining and escalating to the relevant parties as needed. 4. FINANCIAL MANAGEMENT 4.1. To assist in maintaining a system with regular invoicing for clinical trials to ensure that the pharmacy department receives all income due from pharmaceutical companies, R&D or any other sponsor for trial work undertaken If applicable, to ensure correct accurate issuing and/or reimbursement of drug costs in clinical trials where local hospital stock is used. 5. EDUCATION AND TRAINING 5.1. To assist in the provision of the initial and continuing clinical trials training to all new pharmacy staff and to other healthcare professional, if required To assist in the provision of regular information, oral or written, via meetings with other pharmacy staff to ensure that all relevant staff are fully informed of

4 new trials or amendments to on-going trials, and to allow feedback to identify problems or areas for improvement in the service To keep an up to date knowledge and understanding of procedures and practices in the aseptic unit, pharmacy dispensary and clinical trials with a commitment to Continued Professional Development (CPD) by maintaining a portfolio if evidence To keep up to date with all relevant trust mandatory training To achieve key objectives as agreed in appraisal reviews in order to effectively contribute and improve the Pharmacy Clinical Trials Service. 6. RESEARCH AND DEVELOPMENT 6.1. To actively contribute in assisting the Pharmacy Clinical Trials Service to deliver on the Trusts strategy for Research and Innovation. 7. GENERAL DUTIES 7.1. Work flexibly across all of the Pharmacy departments, assisting in covering the work of colleagues during peak periods or absence To ensure that patient confidentiality is maintained at all times in accordance with the Data Protection and Calldicott Awareness policies To perform as an Accredited Checker Technician if selected, after completion of a nationally recognised checking technician programme, performing final accuracy checks on dispensed items against prescriptions for discharge, outpatients, in-patients and Controlled Drug stocks To participate in departmental weekend and Bank Holiday rotas as required, and maintaining dispensary experience and competence as part of the weekend team To be aware of and adhere to departmental and Trust procedures and policies at all times. The post holder will contribute to the provision of patient services including weekend working and Bank Holiday cover according to departmental rotas and extra contractual arrangements. The post holder will contribute to the out of hours (on-call) pharmacy service providing support I back-up, in accordance to departmental rotas. The post holder will undertake other duties as may be required to achieve the Trust s objectives, commensurate with the grading of the post The post holder will abide by the NHS code of conduct for managers, the Trust s core behaviours for staff and managers, and all other Trust policies, including standing financial instructions, research governance, clinical governance, patient and public involvement, codes and practices and health and safety policies. Although this is a list of the key responsibilities of the post it is expected that the post holder and manager will develop and define the detail of the work undertaken. Any changes to the key responsibilities will be the subject of consultation with the post holder. GENERAL INFORMATION:

5 TRUST VISION AND VALUES The Trust is clear on its vision and values and aims to make sure that they are reflected in all areas of activity. Our vision is simple; To Deliver the Best in Care. Our values apply to every member of staff. They are to treat all with respect, to take personal and team responsibility, to look to improve the way we do things (innovation) and to act with honesty in all we do. TRUST POLICIES AND PROCEDURES The post holder will be required to comply with all policies and procedures issued by and on behalf of University Hospitals Birmingham. In addition if the post holder is required to work at other organisations premises they must adhere to the specific policies relating to the premises in which they work. All policies and procedures are available on the Trust Intranet and post holders must make themselves familiar with these. CLINICAL GOVERNANCE & RISK ASSESSMENT The post holder must be aware of and ensure compliance with the Trust s Clinical Governance systems and Risk Management systems. CONFIDENTIALITY Your attention is drawn to the confidential nature of information collected within the NHS. The unauthorised use or disclosure of patient or other personal information is a dismissible offence and in the case of computerised information could result in a prosecution for an offence or action for civil damages under the Data Protection Act. DATA PROTECTION If required to do so, the post holder will obtain, process and/or use information held on a computer in a fair and lawful way; and hold data only for the specified registered purposes and to use or disclose the data only to authorised persons or organisations. EQUAL OPPORTUNITIES AND DIVERSITY University Hospitals Birmingham is striving towards being an equal opportunities employer. No job applicant or member of staff will be discriminated against on the grounds of race, colour, nationality, ethnic or national origin, religion or belief, age, sex, marital status or on the grounds of disability or sexual preference. As a member of staff at University Hospitals Birmingham the post-holder will have a personal responsibility to ensure that he/she does not discriminate, harass or bully, or contribute to the discrimination, harassment or bullying of a colleague or colleagues, or condone discrimination or harassment by others. Selection for training and development and promotion will be on the basis of an individual s ability to meet the requirements of the job. The post holder is also required to co-operate with measures introduced to ensure equality of opportunity. As a manager/supervisor the post holder will be responsible for promoting and ensuring that the Trust s Equal Opportunities in Employment Policy is implemented

6 and that staff under his/her controls are aware of their equal opportunities responsibilities. HEALTH AND SAFETY The post holder must make him/herself aware of the responsibilities placed on them by the Health and Safety at Work Act [1974] to ensure that the agreed safety procedures are carried out to maintain a safe environment for other members of staff and visitors. As a Manager/supervisor the post holder is accountable for implementing and ensuring compliance, across his/her own area of responsibility, with the Trust s Health and Safety Policies and Procedures. This includes responsibility for fostering a safety culture in which health, safety and related issues are seen as essential and integral parts in the service activities. The post-holder will have at all times a duty to conduct themselves and to undertake their work, in a safe manner, so not to endanger themselves and others around them. Clearly, the degree of such responsibilities carried out by a particular individual will depend on the nature and extent of his/her work. Should any individual feel concerned over the safety aspects if his/her work, it should be brought to the attention of his/her manager/supervisor and/or Trade Union Safety Representative. The post holder must adhere to the health and safety rules and procedures of the Trust. He/she has a legal duty to use safety devices and equipment provided. All staff will receive a general introduction to health and safety at work as part of their induction. They will also be given advice on fire, security and lifting procedures. MAJOR INCIDENT OR FLU PANDEMIC In the event of a flu pandemic or major incident, the post holder may be asked to undertake other duties not necessarily commensurate to the banding of this role. This could include duties in any part of the hospital. Prior to undertaking any duties, the member of staff will have full training and induction. No member of staff will be asked to undertake duties for which they are not competent or where they feel unsafe in their environment or could put patients or themselves at risk. NO SMOKING POLICY The Trust has a no-smoking policy. Staff are only permitted to smoke in designated smoking shelters. Members of staff must not smoke inside any of the Trust s premises nor in any vehicle used on Trust Business. Members of staff must adhere to the Trust s Uniform Policy and therefore any uniforms must be covered whilst smoking. PUBLIC SERVICE USER AND CARER INVOLVEMENT Under Section 11 of the Health and Social Care Act we have a duty to involve patients and the public at all levels within the organisation. The post-holder will be required to recognise and value the benefits of listening and responding to patients and recognise that the patients experience is the catalyst for doing things differently to improve the way we deliver services.

7 UNTOWARD INCIDENTS The post holder must take responsibility for incident and near miss reporting and must ensure they adhere to all departmental policies and procedures. REVIEW OF THE ROLE This job description will be subject to review and amendment, in consultation with the post holder, to meet the changing needs of the service and the organisation. This role profile is designed to identify principal responsibilities. The post holder is required to be flexible in developing the role in accordance with changes within the Trust s management agenda and priorities. Although this is a list of the key responsibilities of the post it is expected that the post holder and manager will develop and define the detail of the work to be undertaken. The Trust is committed to equal opportunities, providing opportunities for flexible working and is a no smoking organisation.

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