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Lead Clinical Trials Pharmacist @ East and North Hertfordshire Teaching NHS Trust

Northwood, England, GBOnsiteFull-timeJob reference C9361-26-0664
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About this role

Job summary

We are recruiting for a Lead Clinical Trials Pharmacist who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients.

We are looking for an experienced pharmacist to lead clinical trials pharmacy at Mount Vernon Cancer Centre (MVCC), giving cancer patients access to new treatments through safe, efficient trial delivery.

You will lead and develop the Trust's clinical trials pharmacy service and be the first point of contact for new trials, driving timely set-up and recruitment. You will act as Lead Pharmacist for compliance with UK clinical trials legislation, GCP and research governance, including sponsor audits and MHRA inspections, and ensure the safe management of Investigational Medicinal Products on all sites.

You will advise investigators on trial design and costing, negotiate and monitor trial income, and oversee the Baxter SLA and quality assurance audits. You will also provide specialist clinical pharmacy support to cancer patients.

You will be a GPhC-registered pharmacist with a postgraduate diploma in clinical pharmacy (or equivalent), substantial hospital experience including oncology, experience of managing clinical trials or IMPs, financial awareness and proven leadership skills.

At the heart of everything we do are our core values: Include,Respect, andImprove. We encourage you to embrace these values throughout the recruitment process and in your role with us.

Main duties of the job

We offer professional development and the chance to shape research at Mount Vernon. We welcome applications from everyone.

You will line-manage the Specialist Pharmacist and Clinical Trials Support Technicians, lead recruitment and workforce planning, ensure staff are GCP-trained, and deputise for the Head of Pharmacy.

Lead the Trust's pharmacy clinical trials service and be the first point of contact for new trials, ensuring timely set-up and recruitment.

Act as Lead Pharmacist for compliance with UK clinical trials legislation, GCP and research governance, including sponsor audits and MHRA inspections.

Ensure the safe management of Investigational Medicinal Products (IMPs) on all Trust sites, including unlicensed medicines.

Advise investigators on trial design, feasibility, costing and formulation.

Maintain SOPs, implement trial amendments on time, and build trial protocols on the electronic prescribing system.

About us

At East and North Hertfordshire Teaching NHS Trust, we are proud of the range of general and specialist services we provide and our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible and innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now.

We run the following hospitals

  • The Lister Hospital, Stevenage
  • New Queen Elizabeth II (New QEII), Welwyn Garden City
  • Hertford County, Hertford
  • Mount Vernon Cancer Centre (MVCC), Northwood

We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation and our staff and patients are at the heart of delivering this ambitious agenda.

We are committed to a positive work life balance for our employees. This means that any employee is entitled to seek to work flexible working patterns and we are committed to listen and consider all requests. Such requests, of course, have to be made and considered formally, and will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.

Job description

Job responsibilities

Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.

Person Specification

Qualifications / Training

Essential

  • Masters degree MPharm (or equivalent)
  • Membership of the General Pharmaceutical Council
  • Post Graduate Diploma in Clinical Pharmacy or equivalent
  • Evidence of continuing professional development
  • Up to date Good Clinical Practice (GCP) training

Desirable

  • Independent prescriber
  • Member of the RPS faculty, Royal Pharmaceutical Society (RPS)
  • Member of British Oncology Pharmacy Association (BOPA)
  • Management or leadership qualification
  • Qualification or formal training in research methodology or clinical trials

Previous Experience

Essential

  • Relevant post-registration experience within hospital pharmacy, including oncology
  • Experience of managing and supplying Investigational Medicinal Products (IMPs) within an NHS pharmacy clinical trials service
  • Experience of working with sponsors, monitors and research teams, including preparing for and hosting monitoring visits and audits
  • Financial awareness, including trial costing, income monitoring and drug budgets
  • Experience of providing clinical pharmacy services and medicines information and advice
  • Experience of working as part of a multi-disciplinary team
  • Experience of managing and developing staff
  • Experience of writing and maintaining SOPs and policies

Desirable

  • Experience of contract or cost negotiation with commercial sponsors
  • Experience of leading or contributing to MHRA GCP inspections
  • Experience of building protocols on an electronic prescribing system
  • Experience of working with aseptic compounding units or third-party suppliers, including service level agreement monitoring
  • Audit, research and development, including recognition through publication or presentation
  • Experience of recruitment and selection, and of deputising for a senior manager

Skills

Essential

  • Effective communication skills, verbal and written
  • Good presentation skills
  • Ability to influence and negotiate with medical, nursing, research and pharmacy staff and external organisations
  • Ability to work on own initiative and as part of a team
  • Ability to work under pressure, highly organised, able to prioritise work and meet deadlines
  • Ability to manage and implement change
  • Problem solving skills and able to manage difficult and ambiguous problems
  • Good analytical and judgemental skills, with attention to detail
  • Ability to interpret national and legal guidance and turn it into local policy
  • Training skills; ability to train and act as mentor to other members of staff
  • Good conflict resolution skills
  • IT literate and able to use Microsoft Office programmes, e.g. Excel and Word

Desirable

  • Leadership skills, able to take responsibility and delegate effectively
  • Able to lead on short- and long-term projects
  • Critical appraisal skills

Knowledge

Essential

  • Good Clinical Practice (GCP) and UK clinical trials legislation and research governance
  • Handling, labelling, accountability and supply of IMPs and unlicensed medicines
  • Well-developed therapeutic and clinical pharmacy knowledge, including oncology
  • Need for confidentiality
  • Up to date knowledge of national pharmacy and research issues
  • NHS organisational structure
  • Preparation of written reports and procedures
  • Understanding of the importance of adherence to SOPs and legislation
  • Awareness of new developments in cancer therapy and clinical research

Desirable

  • Knowledge of NIHR research delivery arrangements and HRA/R&D approval processes
  • Health and Safety

Other requirements

Essential

  • Experience and evidence of engagement around the equality, diversity and inclusion agenda. Able to actively support the development of a culture that recognises and promotes equality, values diversity, and actively leads by example in deploying these qualities
  • Understands the impact on equality, diversity and inclusion issues in all aspects of service delivery and planning
  • Role model our Trust values every day
  • Able to participate in the pharmacy Emergency Duty Commitment on -call rota and the Saturday, bank holiday and late duty rotas

Desirable

  • Ability to work across sites if requested

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

East and North Hertfordshire Teaching NHS Trust

Address

Mount Vernon Cancer Centre

Rickmansworth Road

Northwood

HA6 2RN

United Kingdom

Employer's website

https://www.enherts-tr.nhs.uk/ (Opens in a new tab)

Skills

NHS TrustManagementNHSPharmacyPermanentHealthcare

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