Clinical Trials Pharmacist

Job overview

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 Trials

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

Detailed job description and main responsibilities

• 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.
• 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.
• 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.
• 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.
• Promote regulatory compliance across all clinical research services within pharmacy.
• 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.
• 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.
• To support the pharmacy department through any internal or external audits.
• To participate in departmental, Trust and national risk management schemes such as error reporting systems and intervention monitoring.
• Report to the senior pharmacist for clinical trials on all issues related to clinical trial activity within department.
• Provide written reports on activity, regulatory compliance and financial positions to pharmacy and R&I staff as required.
• 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.
• Facilitate the updating of all pharmacy staff on issues related to clinical trials.

General Responsibilities

• 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.
• 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.
• 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.
• To attend meetings relevant to role where required.
• To participate in Continuing Professional Development ensuring relevant knowledge and skills are up to date, meeting the professional requirement of the General Pharmaceutical Council.
• 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.
• To behave in a manner at all times that is in accordance with the professional standards set by the General Pharmaceutical Council
• Undertake all other related duties which may be required in accordance with the changing needs and practices of the department and organization.

Aseptic Services

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

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.