Detailed job description and main responsibilities
* Act as the UHCW pharmacy department pharmaceutical link with any trials related agencies involved with clinical trials and in particular aseptic clinical trials.
* Ensure all dispensed clinical trials drugs comply with UK legislation, EU directives, MHRA regulations, national & local guidelines and practices.
* Ensure patients receive their therapy in a safe and timely manner.
* For all aseptic clinical trials:
o Ensure all appropriate documentation is created, maintained and archived within an approved QA document control system. This includes standard operating procedures, accountability logs, worksheets and other relevant documents.
o Ensure all staff receive appropriate training relating to GCP, GMP and individual trials.
o Ensure appropriate supplies of trial medication are maintained and storage is appropriate and meets current regulations.
* As the specialist technician, ensure a feasibility review and assessment of any aseptic clinical trial involving pharmacy takes place and share the results of this assessment with the clinical trials team.
* Support the implementation of new services (e.g. implementation of ATMP studies) and regional and national initiatives, such as the HRA Technical Review and EDGE Trial Management System.
* Support the Senior Technician Clinical Trials to ensure that the trials workload within aseptic services laboratory is organised in an efficient and timely manner, this will include planning work in advance.
* Advise, when required, on matters relating to aseptically dispensed clinical trial items, including reference where appropriate to patients' records retained within the department. To liaise with clinical staff in an appropriate advisory capacity.
* Develop the aseptic clinical trials service and work proactively to ensure the smooth introduction of new products and systems.
* Participate in regular audits and reviews of aseptic and cancer services, clinical trials and clinical trial standards and processes in particular relating to clinical trial practice and activity.
* Participate in issues related to clinical trials governance. This includes, but is not limited to, review of clinical trial incidents, participating in MHRA and other inspections, development of standard operating procedures and undertaking risk assessments. In addition, working in association with other trial technicians and trial pharmacists to ensure appropriate governance arrangements are in place and ensure appropriate mechanisms for reporting and acting on any incidents.
For further details please see the attached job description.
For an informal discussion about the role or further information please contact Stacey Clarke (Telephone: 024 76 966042 or Email: StaceyAnn.Clarke@uhcw.nhs.uk).
Person specification
Qualifications
Essential criteria
* See supporting documents
Desirable criteria
* See supporting documents
Experience
Essential criteria
* See supporting documents
Desirable criteria
* See supporting documents
Knowledge
Essential criteria
* See supporting documents
Desirable criteria
* See supporting documents
Skills
Essential criteria
* See supporting documents
Desirable criteria
* See supporting documents
Commitment to Trust Values and Behaviours
Essential criteria
* See supporting documents
To ensure that we provide world-class patient care, UHCW recruits people that can demonstrate the Trust's Values and Behaviours in their everyday life. Therefore, if you are invited to interview, you will be undertaking a Values Based Interview/Assessment, which explores not only what you do but how and why you do it.
Before applying, we encourage you to review the Trust's Values and Behaviours which can be accessed on the right side of this page under the job description.
The Supporting Information Section in your application should therefore reflect your understanding of the Trust's Values and associated Behaviours. You will be expected to provide us with examples from work experience and/or personal life which demonstrate these values through your behaviour.
The Trust is committed to Equal Opportunities within the workplace. All vacancies will be considered for Job Share unless otherwise stated. All applicants who have a disability and who meet the minimum criteria for the job will be interviewed. Where a post has an overwhelming response, this Trust may use random selection in order to reduce numbers to interview, any disabled applicants will automatically be guaranteed an interview and will be exempt from this process.
In submitting an application form, you authorise University Hospital Coventry & Warwickshire NHS Trust to confirm from your previous or current NHS employer and other prior employers; previous NHS service details and personal data held about you, including Occupational Health data (inoculations and screening tests). This data will be transferred using NHS Electronic Staff Record and third-party systems via an automated process and only used for the purposes of obtaining and maintaining accurate employment records, should you be appointed to the post.
UHCW NHS Trust, by virtue of its Green Plan, is committed to ensuring that the way we provide services minimises the impact on the environment and the future health of the public e.g. zero waste to landfill, reducing our carbon footprint and increasing our recycling and reuse percentages.
If you are successful at interview you will receive a conditional offer of employment and we'll ask you for information so that we can carry out pre-employment checks. You must successfully complete all pre-employment checks to progress to a final unconditional offer.
We must confirm the identity of our staff and their right to work in the United Kingdom. We will ask you to submit proof of your identity and right to work documents via a secure digital platform approved by the Home Office, named TrustID. Alternatively, you may be asked to attend our office with original documents.
Depending on your level of exposure with patients you may be required to undertake a Standard or Enhanced DBS. The cost of this check will be charged to you and will be deducted from your salary over the first 3 months of employment at the current rate.
All correspondence will be sent by email; please check your account regularly including your Junk/SPAM folders.
Employer certification / accreditation badges
Applicant requirements
You must have appropriate UK professional registration.
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
Documents to download
* Job Description and Personal Specification (PDF, 560.3KB)
* Welcoming Applicants with Disability (PDF, 98.9KB)
* Candidate Information (PDF, 291.8KB)
* How to complete an application form & Values Fact Sheet (DOCX, 874.6KB)
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