Role Summary
Assist in the running of the Clinical Trials service in accordance with current UK Clinical Trial Regulations, the Medicines for Human Use (Clinical Trials) regulations 2004 (EU Clinical Trial Directive) and all updates, together with ICH GCP guidelines and departmental procedures and ensure provision of a high-quality service to patients and staff at the Royal Devon University Healthcare NHS Foundation Trust.
Responsible that the principles of Good Clinical Practice (GCP) are adhered to within Clinical Trials and aseptic services and ensures GCP training is completed and updated regularly. Responsible for training the aseptic team in the basic GCP requirements relevant to their job role and for documenting this training.
About the Role
For more information on the Job Description and Responsibilities please click the link below.
More detail about the role
This post provides a unique opportunity to become part of the team working in both the aseptic services team and clinical trials team at the Royal Devon University Healthcare NHS Foundation Trust.
We are looking for an enthusiastic, highly motivated and organised individual with a passion for aseptic services and an interest in research to support the current aseptic service provision and to support all aspects of clinical trial setup, delivery and closeout.
Main duties of the job
Role Summary
To participate in site selection and site initiation visits and lead on the set-up, maintenance and close-down of clinical trials including planning and timetabling activity and workload in support of this activity.
Ensure the efficient development and maintenance of essential pharmacy trial documentation in accordance with the protocol and other national and local guidelines and ensure accurate completion of drug accountability logs and stock sheets, filing and pricing of commercially available items as appropriate.
Pro-actively contributes to policy and service improvement initiatives in Clinical Trials Pharmacy by assisting in the development, maintenance and implementation of SOPs, policies and procedures relating to clinical trials.
Responsible for line management of staff, including supervision of workload, regular appraisals and attendance/performance management as appropriate according to trust policy.
Responsible for review of clinical trial protocols impacting onto the aseptic services in liaison with the Principal Pharmacist-Technical Services with a view to approving uptake of the trial within the Trust and development of procedures for running the trials.
Responsible for the daily management and organisation of the daily workload planning and staff utilisation within the aseptic unit, including personal participation as required, under the direction of the Chief Technician-Aseptic Services. Ensures that safe systems of work as agreed locally are followed at all times and to comply with all professional and legal requirements.
Performs pre-process and in-process accuracy checks for intravenous additives, parenteral nutrition bag, cytotoxic products, intrathecal injections and clinical trials after completing successfully external accredited checking course.
Participates in the continued maintenance and monitoring of environmental standards within the Aseptic Service facilities and to undertake regular personal assessment of personal quality assurance standards including broth tests, finger dabs etc. and to ensure that these satisfy regional and national standards.
Ensures that an efficient aseptic dispensing and distribution service is provided to patients and staff which is in line with current standards and conforms to agreed service deadlines within the service level.
Job responsibilities
The full job description outlines the key areas of responsibility for the role and the person specification details the qualifications, skills, knowledge and experience required.
More detail about the role
We are looking for an individual who holds and NVQ level 3 in Pharmacy Services / BTEC in Pharmaceutical Sciences or equivalent qualification who is registered with the GPhC.
You should have excellent communication and organisational skills and the ability to work flexibly and adapt to changing priorities and demands.
You should be able to work effectively and accurately under pressure and be able to lead others and effectively develop a team.
You will have good computer skills and a knowledge of quality assurance of aseptic preparation and Good Manufacturing Practice.
If you believe you have the skills and experience necessary to fulfil this role we look forward to hearing from you.
Working Pattern: 37.5 hours per week participating in flexible working arrangements including late duties, weekends, bank holidays and on call as appropriate.
Interview Date: Wednesday 10th April 2024.
For further information please contact: Jade Smith, Specialist Senior Clinical Trials Technician on jade.smith70@nhs.net or 01392 402444 or Katie Copland, Chief Technician Aseptic Services on katie.copland@nhs.net or 01392 404811.
As an inclusive employer, the Royal Devon values diversity and is committed to creating a culture of inclusivity where everyone can be themselves and reach their full potential. We believe in fostering a sense of belonging and actively encourage applications from individuals of all backgrounds, cultures, and abilities. We recognise the advantages of having a diverse workforce that reflects the communities we serve.
Preference will be given to staff with ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon.
The Royal Devon University Healthcare NHS Foundation Trust reserves the right to close vacancy when sufficient applications have been received.
The Royal Devon University Healthcare NHS Foundation Trust was established in April 2022, bringing together the expertise of both the Royal Devon and Exeter NHS Foundation Trust and Northern Devon Healthcare NHS Trust.
About Us
Stretching across Northern, Eastern and Mid Devon, we have a workforce of over 15,000 staff, making us the largest employer in Devon. Our core services, which we provide to more than 615,000 people, cover more than 2,000 square miles across Devon, while some of our specialist services cover the whole of the peninsula, extending our reach as far as Cornwall and the Isles of Scilly.
We deliver a wide range of emergency, specialist and general medical services through North Devon District Hospital and the Royal Devon and Exeter Hospital (Wonford). Alongside our two acute hospitals, we provide integrated health and social care services across a variety of settings, including community inpatient hospitals, outpatient clinics, and within people’s own homes. We also offer primary care services, a range of specialist community services, and Sexual Assault Referral Centres (SARC).
Our state-of-the-art equipment, leading technologies and strong links to local universities put us at the forefront of research and innovations, enabling us to provide world-class care to our local communities.
Our values are at the heart of everything we do, click here to find out more
It has never been a more exciting time to join the Royal Devon, as you will help to shape our services as we continue along our integration journey.
Benefits
Looking after you is important to us.
We strive to help our staff create a healthy work-life balance through flexible working schemes and our family friendly policies.
If you are starting out in the NHS, you’ll start with 27 days paid annual leave (plus bank holidays), rising to 33 days plus bank holidays.
You will benefit from access to our own comprehensive occupational health services, including counselling, onsite wellbeing activities and groups.
We will work together to maintain a culture that develops and supports you and your team.
This might include funding for a care certificate, a degree or leadership qualifications. Or it might include days off to study, engage in CPD or rotational placements to help you hone your skills. Wherever you are heading in the NHS, we will help you get there.
Salary is not the only financial benefit
You will have access to an extensive range of staff discounts on shopping, fitness and leisure options and you can spread the cost of technology and home appliance purchases from major retailers. You will also have access to other benefits including:
- National discount services such as the Blue Light Card and Health Service Discounts.
- Salary sacrifice options including our OFSTED rated outstanding nursery onsite at Exeter
- Car lease schemes.
- The NHS Pension scheme (one of the most generous and comprehensive in the UK).
- Cycle to work scheme
These are just a few of the benefits available – if the role is something you are interested in, we would love to hear from you.
