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Clinical Trials Pharmacist @ The Christie NHS FT

GBOnsiteFull-timeJob reference C9413-26-0710
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About this role

Job summary

We have an exciting opportunity for a motivated pharmacist to join our Clinical Trials Pharmacy team. You will work closely with research teams to support the set-up and delivery of clinical trials and aseptic services across the Trust.The Christie has a dedicated Clinical Trials Pharmacy Department supporting more than 600 experimental medicine studies. As part of this team, you will help ensure patients have access to the latest developments in oncology and haematology investigational medicines. You will work in a multidisciplinary environment with pharmacy, clinical, and research colleagues to deliver safe and innovative treatments.The department is involved in large-scale collaborative projects and has strong academic links with the University of Manchester. Many team members have undertaken postgraduate training or secondments, and we are committed to supporting your development.You must be registered with the General Pharmaceutical Council. Comprehensive training will be provided, and while prior hospital or clinical trials experience is an advantage, we are particularly seeking individuals with the enthusiasm, adaptability, and collaborative outlook needed to thrive in this dynamic specialty. If you are passionate about advancing cancer care and supporting cutting-edge clinical trials, we want to hear from you.

Main duties of the job

Clinical Trialso Act as pharmacy lead for designated research teams, advising on CTIMPs, assessing protocols and resolving pharmaceutical issues.o Evaluate study capacity, safety, resources and financial implications, providing timely feedback and reports.o Maintain systems that ensure compliance with research governance, ICH GCP, GMP, clinical trials legislation and local requirements.o Prepare product and COSHH risk assessments; support development of prescriptions and study documentation before trial opening.o Support audits, risk management, regulatory reporting and staff training.General Responsibilitieso Resolve clinical and dispensing queries and provide safe clinical pharmacy services, including screening and checking trial, chemotherapy, inpatient and outpatient prescriptions.o Participate in relevant meetings, professional development, mandatory training, departmental rotas, extended-hours, weekend, bank holiday and on-call services.Aseptic Serviceso Review and develop aseptic and clinical trial procedures, worksheets, labels and master documents.o Clinically review, final-check and release aseptically prepared items, resolving issues with medical and nursing teams.o Provide evidence-based advice on safe, effective and economical medicines use, particularly IV therapy, and understand protocols requiring aseptic manipulation.

About us

The Christie is one of Europe's leading cancer centres, looking after more than 64,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 25% patients are referred to us from other parts of the country.

We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.

We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK's National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.

Job description Job responsibilities

Clinical Trials

1. Act as nominated pharmacy lead to a defined group of research teams. Provide pharmaceutical advice on the conduct of CTIMP trials and assess study requirements and resolve pharmaceutical issues with the research teams.

2. Lead on the evaluation of study protocols for designated disease groups and consider implications within pharmacy (capacity, safety and resources). Provide timely feedback to stakeholders.

3. To monitor, document and advise on the financial implications of designated studies to the Senior Pharmacists for Clinical Trials, R&I, finance and the Director of Pharmacy.

4. Maintain systems and processes to ensure that all trial related activity is conducted in accordance with the Research Governance Framework for Health & Community Care, ICH GCP guidelines, GMP principles, current Medicines for Human Use (Clinical Trials) Regulations and along with any other local legal/regulatory requirements.

5. Promote regulatory compliance across all clinical research services within pharmacy.

6. Prepare comprehensive risk assessments related to the Control of Substances Hazardous to Health and advise key staff accordingly in relation to handling, labelling and product evaluation for all new products used in clinical trials.

7. To assist the clinical trials pharmacist team, with prescription proforma development for any new clinical trial regimens being set-up and checking any pharmacy specific relevant paperwork before a trial opens for recruitment.

8. To support the pharmacy department through any internal or external audits.

9. To participate in departmental, Trust and national risk management schemes such as error reporting systems and intervention monitoring.

10. Report to the senior pharmacist for clinical trials on all issues related to clinical trial activity within department.

11. Provide written reports on activity, regulatory compliance and financial positions to pharmacy and R&I staff as required.

12. Act as a resource for staff within R&I division. To be responsible for providing formal advice and specialist training sessions for Christie staff on all pharmaceutical aspects of new and existing trials.

13. Facilitate the updating of all pharmacy staff on issues related to clinical trials.

General Responsibilities

1. To manage and resolve any clinical or dispensing queries with regards to patients trial prescriptions to maintain high standard of patient care, assisting technical staff with day-to-day queries where appropriate.

2. To support the provision of clinical pharmacy services within the dispensaries and the aseptic services unit. Responsible for the clinical screening/review of prescriptions, both in-patients and outpatients, and to accurately check and supply medicines to patients, including clinical trials in accordance with all departmental, Trust and national standards, procedures and policies.

3. To participate in the pharmacist rota for the clinical screening of prescriptions, including clinical trial prescriptions within the dispensary and facilitate safe and effective screening /review of prescriptions for chemotherapy regimens, clinical trials and treatment strategies in use at The Christie, including full awareness of the intrathecal chemotherapy policy. Following local, Trust and National guidelines for safe medicines practice.

4. To attend meetings relevant to role where required.

5. To participate in Continuing Professional Development ensuring relevant knowledge and skills are up to date, meeting the professional requirement of the General Pharmaceutical Council.

6. To participate in mandatory training in line with the trust and departmental requirements. To participate in all departmental rotas, extended hours weekend service and bank holiday working and the emergency on-call pharmacy service, as required.

7. To behave in a manner at all times that is in accordance with the professional standards set by the General Pharmaceutical Council

8. Undertake all other related duties which may be required in accordance with the changing needs and practices of the department and organization.

Aseptic Services

1. To assist and advise with the review, preparation and development of aseptic/clinical trial standard operating procedures, worksheets, labels, guidelines and master documents as appropriate. To validate these documents by signature where required.

2. To be responsible with other pharmacists for the provision of professional input to the clinical review of prescriptions for aseptic/clinical trial dispensing and the resolution of any clinical issues, liaising with medical or nursing staff as necessary.

3. To be responsible with other pharmacists working within Aseptic services for the clinical screening, final check, release and issue for administration of items prepared within the service area, ensuring that all paperwork is complete and retained for future requirements relating to drug recalls.

4. To provide evidence-based medicines advice to ensure safe, effective, economical and timely use of medicines, in particular IV therapy.

5. To have an understanding and awareness of all clinical trial protocols requiring aseptic manipulation, in particular pharmaceutical and clinical aspects, and safety and handling issues.

The duties of the post may be varied with the agreement of the post holder in accordance with the changing needs and practices of the department and organization.

Person Specification

Qualifications Essential

oMasters Degree in Pharmacy oCompletion of pre-registration training oRegistered with GPhC oEvidence of continuing professional development

Desirable

oClinical trials experience oDiploma in clinical pharmacy or relevant postgraduate qualification oMembership of Royal Pharmaceutical Society

Experience Essential

oExperience of providing medicines information and advice oExperience of service improvement/project management

Desirable

oExperience of working within a hospital environment oExperience within the oncology field oKnowledge and understanding of the principles and regulations underlying aseptic services oStaff supervision & training

Skills Essential

oExcellent communication skills, both verbal and written oAbility to work on own initiative and as part of a team oSelf-motivating oAbility to work under pressure, highly organised, and working to deadlines oAbility to manage and implement change oAbility to influence and negotiate with medical, nursing and pharmacy colleagues oIT literate oAbility to recognise own limitations

Desirable

Understanding of the skills required within aseptic services

Knowledge Essential

oNHS Cancer Plan, NICE oExcellent knowledge of clinical use of medicines oCost-effective use of medicines and medicines management

Desirable

oKnowledge of drug use in oncology oKnowledge of procedures within an aseptic unit oGCP/GMP oFinancial awareness oNational Intrathecal guidelines

Values Essential

oAbility to demonstrate the organisational values and behaviours

Other Essential

oEmergency on call commitment oBank holiday working oFlexible working hours

Desirable

oDriver's license

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.

Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

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 The Christie NHS FT

Address Pharmacy Trials - E00922

Manchester

M20 4BX

United Kingdom

Employer's website https://www.christie.nhs.uk/ (Opens in a new tab)

Skills

PermanentHealthcareNHSPharmacy

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