Specialist Clinical Trials Pharmacist

Job summary

An exciting opportunity has arisen for a dedicated pharmacist post to lead, manage and deliver the pharmacy service for clinical trials at NUH. Your focus will be on a wide range of clinical specialities (outside of cancer), working as part of the established pharmacy clinical service and technician-supported clinical trials teams and in close liaison with the clinicians and research teams . The post holder will also contribute to the delivery of a specialist clinical pharmacy service to NUH patients.

This role will support the Principal Pharmacist R&I in the development of the pharmacy clinical trials service, increasing the portfolio of early-phase clinical trials and advanced therapy investigational medicinal products research.

You must be able to work accurately under pressure, use your own initiative, and be able to plan and manage your own workload and that of others. You will be flexible, have good organisational and communication skills and be able to work to and meet changing deadlines.

Main duties of the job

JOB SUMMARY

To be the pharmacy lead for clinical trials of medicinal products conducted in a variety of clinical divisions excluding cancer.

To be responsible for appraisal of clinical trials of medicinal products and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) advanced therapy investigational products (ATIMPs) and non - investigational medicinal products (NIMPs).

To contribute to the delivery of a high quality clinical pharmacy service

The post holder will have regular service commitments between QMC and City Campuses.

There is an expectation of close working as required with clinical pharmacy colleagues in the therapeutic areas where research is being undertaken.

About us

With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.

Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH

Job description

Job responsibilities

KEY JOB RESPONSIBILITIES

Service Management and Development

Takes responsibility for the delivery, management and development of the pharmacy clinical trials service. Attends specialty clinical trials meetings as appropriate. In co-operation with the Research teams, and the Principal Pharmacist, Research and Innovative Treatments, identifies and prioritises clinical trial pharmacy services to ensure national and local agendas are delivered. Develops, implements and audits pharmacy clinical trials practices. Provides expert advice regarding trials to the Pharmacy Department, the relevant specialties, consultant teams, research teams and other clinical specialties as required. Supports the Chief Pharmacist and Clinical Director of Medicines Optimisation and the Principal Pharmacist, Research and Innovative Treatments in clinical trials management issues and projects. Participates and supports the development of business plans and department and clinical strategies, in response to expansion of services, new consultant appointments, national initiatives and locally identified risks. Contributes to the overall organisation, administration and management of the Pharmacy Clinical trials team

Clinical Trials Service (80%)

Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service

Works according to GCP guidelines and agreed pharmacy clinical trials procedures.

Critically appraises clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of the study are deliverable and safe, in liaison with the pharmacy production unit staff as required.

Calculates pharmacy support costs clinical trials protocols, liaising with the speciality research teams, sponsors and NUH Research and Innovation (R&I) Department where NUH is the chief investigating site.

Liaises with NUH R&I and research teams, to ensure timely appraisal, costing and pharmacy approval for clinical trials.

Leads and finalises the set-up of clinical trials, writing and/or checking dispensing procedure, and manufacturing worksheets where applicable.

Is accountable for adherence to protocol requirements for investigational medicinal product (IMP) management.

Facilitates the Principal Pharmacist for Research and Innovative services in the development of new services to deliver novel and innovative therapies to patients with the research setting.

Participates in the provision of a clinical pharmacy service for patients recruited into clinical trials within the Trust

Assesses and clinically verifies trial specific prescriptions to ensure safe and rational prescribing according to the study protocol.

Provides trial medication and any additional supporting treatment for inpatient, discharge or outpatient use.

Counsels patients to ensure medication usage according to the protocol and to improve patient understanding of medication using trial specific patient information.

Assesses patient compliance via review of trial medication returned by trial subjects and patient counselling.

Contributes to detection of possible adverse events and prompt notification of the investigator and sponsor, where relevant.

Accuracy checks prescriptions, dispensed by others, for accuracy of interpretation, supply, labelling and accountability recording.

Clinical Practice (20%)

Supports the provision, of a high quality, comprehensive specialist pharmacy service

Demonstrates professional accountability to patients under their care.

Provides specialist advice and guidance on all issues relating to prescribing and therapeutics of drugs in line with national and local guidelines.

Uses specialist knowledge and experience, and appraises information from numerous sources to provide highly specialised advice on drug therapy to medical, nursing and pharmacy staff. This may include advice about experimental medicines or of medicine use where limited evidence exists.

Assesses and verifies prescription and charts and prescribing, including chemotherapy, in order to ensure safe, rational and effective prescribing within existing guidelines.

Identifies potential adverse reactions to medicines, drug interactions and Intravenous drug compatibility issues.

Establishes drug histories and enables the use of patients own medicines.

Counsels patients on their drug therapy to improve medication usage and patient understanding of their medication during in-patient stay and after discharge.

Provides medications for individual patients during their stay in hospital and at discharge as necessary.

Requests and interprets clinical tests and serum drug levels to monitor and make recommendations to improve effectiveness of drug therapy.

Pro-actively liaises with other members of the multidisciplinary team in order to make recommendations about drug therapy to improve patient outcomes.

Encourages and monitors adherence to hospital formulary, trial protocols and national guidelines.

Amends prescriptions on verbal orders from prescribers and transcribes prescriptions for patients being discharged.

Is accountable on the clinical areas served (wards and clinics) for adherence to all pharmacy policies and procedures relating to medicines management.

Works with the other pharmacists in the provision of a high quality clinical pharmacy service to wards in the hospital as directed by the Assistant Head of Pharmacy - Clinical Services Lead. Provides professional supervision in the dispensary by:

Final checking and release of manufactured/dispensed medicines, in accordance with good manufacturing practice and departmental procedures.

Accurately interpreting and clinically screening prescriptions, referring to relevant protocols and intervening when necessary.

Financial Resource Management

Calculates the cost of pharmacy support for clinical trials protocols, liaising with the specialty research teams, sponsors and NUH R&I Department. Identifies potential cost savings and/or efficiency initiatives in medicines usage, relevant to clinical trials. Ensures trials fees are invoiced and reclaim mechanisms for the medicine costs are accounted for and implemented, liaising with the Specialist Pharmacist High-cost drugs management.

Human Resource Management

Acts as a role model Supervises and teaches junior staff (rotational and diploma pharmacists, technicians, pre-registration pharmacists, pharmacy students) Leads on the submission of business cases to secure funding for service developments/new pharmacy posts within the specialty, in liaison with the team leader. Assists in the recruitment of new staff. Contributes to the performance and line management of pharmacy staff working within the Clinical trials teams, including appraisals.

Research and Development

Undertakes, supervises and participates in research, and if suitable registers for a further degree ( DPharm, MPhil). Actively evaluates and integrates research evidence into practice to develop and improve pharmacy services within the directorate and the department. Maintains contact with appropriate national and local specialist groups to facilitate best practice to be identified and incorporated into NUH practice.

Education and Training

Works with the Principal Pharmacist, Research and Innovative Treatments, and the Education & Training pharmacists to provide and develop a competency framework, training plans and materials on issues relating to Clinical Trials to ensure training facilities for Advanced Specialist Pharmacy Practice Framework are available. Delivers teaching to nursing, medical, pharmacy and other AHP staff about medication issues within Clinical Trials and the relevant specialties, as appropriate Provides education, training and assessments for pharmacists on Clinical Diplomas, Pre-Registration Pharmacists, other pharmacy, nursing and medical staff.

24 .Develops and maintains portfolio of Specialist Pharmacist Practice. Undertakes and documents Continuing Professional Development .

General

Participates in rostered flexible working including evening, weekend and bank holiday arrangements in line with service commitments. Participates in the back-up on-call service for shift working pharmacists as required. Undertakes any other duties that may reasonably be required as agreed by senior staff.

Freedom to Act

Makes and is accountable for clinical decisions in the interests of patient safety and clinical outcome within the post holders specialty and sphere of competence. Works under own initiative and acts independently within relevant national and local legislation, protocols and guidelines and in accordance with objectives set between the Chief Pharmacist and the Assistant Chief Pharmacist Medicines Finance, Therapeutics and Digital Services Is accountable for own professional actions, working to standards laid down by the General Pharmaceutical council. Acts within NUH policy and procedures. Acts in accordance with current legislation relating to the use of medicinal products and clinical trials. Person Specification

Training & Qualifications

Essential

BPharm/BSc or MPharm/MSc or equivalent Current GPhC registration Diploma/MSc in Clinical Pharmacy, or relevant postgraduate experience Demonstrates continued professional development or equivalent knowledge through extensive experience Awareness of Good Clinical Practice (GCP)

Desirable

Attendance at relevant regional and national Clinical trials courses / meetings Member of relevant specialist pharmacist group Current GCP certification. Teaching/Mentoring qualifications Evidence of leadership qualifications Member of the RPharmS

Commitment to Trust Values and Behaviours

Essential

Must be able to demonstrate behaviours consistent with the Trust's behavioural standards

Experience

Essential

Experience of specialist clinical pharmacy service delivery Awareness of specialist clinical trials service delivery in pharmacy, clinical trial appraisal, set-up, IMP supply and trial maintenance Experience of time management, clinical appraisal , and knowledge of Medicines Information resources and systems Computer literate (word processing, spreadsheets and other software) Training and/or experience in clinical teaching/tutoring, audit, practice research, risk management Comprehensive knowledge and understanding of the formulation, preparation, therapeutic action of medicines Broad knowledge of therapeutics Comprehensive knowledge and understanding of professional and statutory requirements relating to medicines and clinical trials, ICH-GCP, NHS structure, Code of Ethics for pharmacists Knowledge of national disease guidelines, NICE guidance, formulary restrictions and evidence based literature

Desirable

Clinical pharmacy responsibilities at a senior level Experience of specialist clinical trials service delivery in pharmacy. Medicine expenditure analysis and reporting Understanding of commissioning routes Management experience, with responsibilities for pharmacy staff groups Evidence of research or project work

Communication and Relationship skills

Essential

Strong, accurate and concise written and oral communication skills, including presentation skills Confident and assertive; able to defend opinions when challenged Able to empathise and communicate effectively with patients, who may have language difficulties, or other disabilities Able to receive, interpret, summarise, communicate and present complex information to a wide range of professionals across the Trust Proven ability to influence and negotiate with relevant senior clinicians, managers and key stakeholders Tact and diplomacy skills Effective independent and team working skills Proactive and innovative Delegation skills Evidence of team building and leadership skills

Analytical and Judgement skills

Essential

Able to find, analyse and interpret wide range of clinical information Proven problem solving approach on a wide range of clinical issues, and able to think laterally to develop new ideas Able to apply specialist clinical knowledge to interpret and appraise complex clinical trials protocols and resolve issues relating to pharmaceutical aspects of the protocol. Ability to work alone using initiative and make effective decisions Able to work accurately with attention to detail under pressure

Desirable

Medicines Information Skills

Planning and organisation skills

Essential

Able to prioritise, plan, co-ordinate, develop and adjust pharmacy clinical trials services Able to work effectively to short, medium, long-term and changing deadlines Effective time management skills Able to plan, organise and manage own workloads and that of others

Desirable

Management skills

Physical skills

Essential

Keyboard skills Able to perform effectively in front of an audience Able to maintain sustained periods of concentration Must have the ability to wear appropriate PPE required for the role

Desirable

Evidence of application of Microsoft office suite applications beyond basic utilisation.

Other requirements specific to the role ( be able to work shifts/on call)

Essential

Participation in weekend Bank Holiday and Senior back up working rotas

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