Pharmacy Technician Clinical Trials

This exciting new role has been created to support Pharmacy Clinical Trials to deliver R&I objectives to open more trials and for patients to access new and innovative treatments across Frimley Health NHS Foundation Trust. This is a 9 months funded band 5 post for an enthusiastic Pharmacy Technician who is passionate about making a real impact on improving treatments for patients in research. This is a unique opportunity to join the R&I team and work closely with the lead Pharmacist for clinical trials for the delivery of pharmacy clinical trial services at Wexham Park Hospitals. We will offer GCP training and support to complete all relevant competencies. The Pharmacy Department also supports R&I to deliver large-scale hosted clinical trial projects alongside several research partners and have strong links with the University of Oxford.

Main duties of the job

• Support all aspects of pharmacy requirements for handling medicinal products within the context of a clinical trial (dispensing, drug accountability, administration, storage, disposal of medicinal products and monitoring visits).
• Provide support to the lead clinical trials pharmacist to ensure activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good Manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
• Support all aspects of pharmacy requirements to set-up clinical trials.
• Work collaboratively with research teams, pharmacy staff and the clinical trials lead technician at Frimley Park Hospital in the management of clinical trials within the Trust and ensure that all trials are conducted in accordance with the highest possible standards, and in compliance with the principles of GCP (Good Clinical Practice), Good Dispensing Practice and Good Manufacturing Practice.
• Support the clinical trials lead pharmacist with internal, external audits and regulatory inspections by the Medicines and Health Regulatory Authority (MHRA) within pharmacy.

Working for our organisation

Frimley Health NHS Foundation Trust is committed to being an inclusive and disability confident employer and has been awarded the Gold for the Armed Forces Employment Recognition Scheme. We provide first class development opportunities for all staff and have a wide range of professional, management and leadership, and clinical skills training available. Here at Frimley Health NHS Foundation Trust, we know how important it is to have a healthy work life balance; this benefits not only individuals but the patients we care for too. We encourage applications from people who wish to work on a flexible basis, recognising that flexibility may mean a range of different working patterns and hours, we do our utmost to work with our staff to meet their needs and the needs of our service and its users.

Detailed Job Description And Main Responsibilities

KEY TASKS & RESPONSIBILITIES:

• Ensure that all pharmacy clinical trial files contain all necessary documentation and are kept up to date.
• Write, review, and update SOPs for clinical trial activities as and when required, in conjunction with the Clinical Trials Lead Pharmacist, and disseminate these to staff as appropriate.
• Prepare, and update as required, clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with each study’s protocol.
• Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided).
• Audit files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation.
• Ensure that there are robust ‘code breaking’ procedures in place for drug treatments in cases of emergency and test these procedures on a regular basis.
• Attend relevant meetings as determined by the Wexham Park Hospital Clinical Trials Lead Pharmacist.
• Liaise with clinical research associates, research nurses, clinicians and pharmacy staff to ensure effective communication is maintained in respect of clinical trials.
• Arrange and supervise monitoring visits with sponsor representatives, provide documents and action any findings as appropriate.
• Record clinical trials activity and update any databases as required, to assist in the monitoring of pharmacy quality processes, and the preparation of reports for GCP Audits or Inspections.
• Assist with the timely invoicing of pharmaceutical companies for money owed for trial set-up, dispensing and drug reimbursement and keep records of invoicing and subsequent payments.
• Use judgement skills to analyse situations and act promptly to solve service issues and actively develop the service in line with current developments.
• Review clinical trial documentation, assessing the suitability and safety relating to packaging, labelling, shipment, storage, prescribing and dispensing of study medication and make recommendations for changes when appropriate, in conjunction with the Clinical Trials Lead Pharmacist.
• Assist with the review of clinical trials prescription forms supplied by research organisations and assess suitability for use before the trial commences and make recommendations for amendments.
• Dispensing clinical trials: Review prescriptions presented at pharmacy for dispensing and make interventions when prescriptions are incorrect or incomplete.
• Prepare labels ensuring that they meet the required standard and trial-specific dispensing procedures.
• Dispense clinical trials medications ensuring each item is accurately dispensed, and in the correct packaging, according to trial-specific dispensing procedures.
• Complete dispensing records, accurately recording batch numbers, expiry dates and patient information according to each clinical trials protocol.
• Perform the final accuracy check on dispensed clinical trials, if accredited as a Checking Technician (ACT), according to SOPs.
• Organise the timely supply of medications to patients on wards and at home.
• Prioritise and delegate to other pharmacy team members as necessary.
• Communicate with the research team and the Sponsor any delays in supply of study drugs or related research material.
• Responsible for the safe management and stock control of all clinical trial medication including ordering stock, receipt, storage & return or destruction of stock, ensuring all documentation is completed accurately and in a timely manner.
• Responsible for performing ‘close down’ procedures for clinical trials and ensuring that trial documents are archived as per standard operating procedures.
• Work with the Clinical trials pharmacist to ensure all documentation is complete, IMP and site file storage is acceptable, and data is archived appropriately.
• To educate & provide specialist training (in accordance with ICH GCP & UK Clinical Trials Regulations) for staff, with regards to the operational aspects of clinical trials & their documentation and maintain records of such training.
• Undertake formal training sessions, in conjunction with the R & D pharmacist, to educate & train pharmacy staff within the trust in current regulations, guidelines and policies that govern clinical trials.
• Attend mandatory education and training sessions.
• Train new Technicians, Pre-registration Technicians and Assistants by demonstrating techniques and procedures to undertake labelling, dispensing, recording, ordering and receipting study drug supplies.
• Maintain own Continuing Professional Development (CPD) portfolio and provide evidence as per trust policy.
• Support the main dispensary when appropriate for regular dispensing or checking duties and ensure skills are kept up to date.
• Participate in weekend working, bank holidays and late duties as appropriate.
• Achieve objectives agreed at individual performance plan meetings with the Lead Pharmacist.
• Participate in other aspects of delivery of the pharmacy service if required to do so.
• Co-operate with Medicines Information staff in responding to information requests arising from clinical services.
• Comply with pharmacy policies and other Trust policies.

Person specification

Education and Experience

Essential criteria

• Registered GPhC Pharmacy Technician
• Recognised Pharmacy Technician qualification

Desirable criteria

• Accredited checking pharmacy qualification

Communication

Essential criteria

• Excellent verbal and written communication
• Good organisational and time management skills
• Meticulous and methodical attention to detail
• Intermediate level experience of MS Office software including Word, Excel

Desirable criteria

• Knowledge of EPIC, EDGE and IRT (e.g. IWRS)

Professional Specialist Experience

Essential criteria

• Wide understanding of Pharmacy processes
• Broad pharmacy experience with a minimum of 2 years hospital experience
• Ability to respond to routine requests for information and to distinguish those which need to be referred to a Pharmacist

Desirable criteria

• Research Experience
• Knowledge of ICHGCP
• Experience of audit

Frimley Health NHS Foundation Trust (FHFT) has an outstanding reputation and a proud record of achievement. As a well performing, well led and ambitious Foundation Trust, we have exciting times ahead of us. We have an ongoing commitment to improving the health and care services for the 900,000 people we serve across Berkshire, Hampshire, Surrey and south Buckinghamshire. We are proud of the ambitions laid out in our strategy, Our Future FHFT, including our vision to be a leader in health & wellbeing, delivering excellence for our communities. We continue to invest in our services and facilities, including a £10 million upgrade to the hospital maternity unit as well as £49m major new Emergency Assessment Centre on our Wexham Park site. The opening of a brand new £100m state of the art hospital which replaced the existing hospital facility at Heatherwood and are planning to invest further in diagnostics and inpatient capacity at Frimley Park. We have also made significant investment in our quality improvement and digital programmes to support our vision and we will ensure that we achieve our aim of providing the highest quality healthcare to our patients. Our new EPR – Epic – went live in June and we are already beginning to reap the benefits of this ambitious investment.

Our three core values, and the behaviours that support them, guide everything we do and set out what we expect of our staff in the way they treat patients, visitors, service users and each other: Committed to Excellence, Working Together and Facing the Future.