Senior Clinical Trials Pharmacist - Bank

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Detailed job description and main responsibilities

To provide advice and guidance for the Trust regarding the documentation, preparation, storage and use of CTIMP (Clinical Trial investigational medicinal product), to the R&D department, investigators, research staff and other users across the Trust.

To act as a point for contact for Research Teams and escalate if required to the Lead Pharmacist.

Work as a senior member of the UHCW Pharmacy Clinical Trials Team, supporting the management of all clinical trials involving medicines. Including:

• Ensuring pharmacy policies and procedures for the pharmaceutical aspects of clinical trials meet statuary requirements and national and local guidelines.
• Working closely with the Technical Services team to support the safe introduction of clinical trials that involve aseptic manipulations of medicines.
• Undertake risk management.

To manage the overall pharmacy implementation of trials and the Pharmacy Clinical Trials Team.

To review trial protocols to assess whether Pharmacy can support them. Be involved in study feasibility assessment and study setup including prescription, worksheet and SOP generation.

Ensure pharmacy comply with all aspects of EU and UK legislation, GCP, GMP and GDP pertaining to clinical trials.

To follow departmental SOPs for storage, handling, accountability and destruction of Investigation Medicinal Products both within Pharmacy and outside of Pharmacy.

To ensure that UHCW policies and procedures for the pharmaceutical aspects of Clinical Trial management meet statutory requirements and national and regional guidelines. With the assistance of the Pharmacy Clinical Trials Team, ensure the receipt, storage, dispensing and destruction of IMP is safe and secure according to relevant regulations and legislation.

To support the department during MHRA GCP inspections, implementing any corrective or preventative actions required.

To participate in updating and reviewing Pharmacy Clinical Trial SOPs (standard operating procedures) as needed.

Work with investigators and research staff to provide SOPs which will ensure compliance with the study-specific prescribing and administration requirements of IMPs.

To manage the creation and validation of Clinical Trial prescriptions, including using an electronic prescribing system for Chemotherapy prescriptions where possible.

To deliver Clinical Trial training programmes and oversee Clinical Trial training for pharmacy staff.

To review clinical trial incidents and implement corrective and preventative actions as required.

To deputise for specific aspects for the Lead Pharmacist Clinical Trials as necessary.

For further details of the role please see the attached job description

Person specification

Qualification /Training

Essential criteria

• See supporting documents

Desirable criteria

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Experience

Essential criteria

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Desirable criteria

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Knowledge

Essential criteria

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Desirable criteria

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Skills

Essential criteria

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Desirable 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 you 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

• JD PS Senior Clinical Trials Pharmacist (PDF, 504.3KB)
• UHCW Post Card (PDF, 114.3KB)
• Candidate Information (PDF, 406.1KB)
• How to complete an application form & Values Fact Sheet (DOCX, 874.6KB)
• Welcoming Applicants with a Disability (PDF, 53.2KB)