Clinical Trials Pharmacist – Research & Innovation

Job responsibilities

CLINICAL TRIAL RESPONSIBILITIES:

1. To review new clinical trial protocols to ensure sufficient pharmacy resources (staffing and funding) are available; highlighting potential cost, service and capacity issues that may require negotiation with the Research & Innovation staff and trial sponsors.
2. To review the pharmacy fees section of the NIHR Industry Costing Template during trial set up, and feedback any issues to the R&I Finance Manager. Provide timely and accurate pharmacy information on dispensing, storage, maintenance activities etc. to allow the R&I Finance Manager to invoice pharmaceutical companies appropriately.
3. To attend Trust R&I feasibility meetings for new CTIMP trials at an early stage; highlighting any potential cost, service and capacity issues.
4. To act as the pharmacy representative on the R&I Leaders Meetingand other Trust Research Meetings as required, providing specialist pharmacy advice and opinion to R&I,iInvestigators and research staff.
5. To ensure all set up activities are performed in accordance with the pharmacy greenlight checklist; sign off and inform R&I when these processes are complete before recruitment can commence at site.
6. To work in close liaison with R&I with regard to any local or national timelines and targets, key performance indicators, and quality standards to ensure objectives and standards are met with regard to trial activity.
7. To liaise with the and dispensary manager to ensure that production capacity is available for clinical trial services provision.
8. To prepare and update pharmacy dispensing guidance for each trial and related documents including trial feasibility form, prescriptions, accountability and temperature data logger data.
9. To ensure HRA approval, R&I approval, ethics approval and the Medicines and Healthcare Products Regulatory Agency (MHRA) approval are all in place before any clinical trial commences and drugs are issued from pharmacy in liaison with investigators and members of the research team.

1. To design prescriptions and drug accountability documentation for clinical trials when required.
2. To record status of clinical trials with pharmacy involvement on the EDGE database system and to make pharmacy related entries onto the relevant electronic prescribing systems Epic, ARIA and Chemocare, with respect to trial patients.
3. To provide pharmaceutical input into paediatric chemotherapy services by participating in paediatric MDT and dispensing of trial/non-trial medications when required.

1. To provide information to medical staff, nursing staff and patients on Investigational Medicinal Products (IMP) as required.

1. To ensure there are appropriate pharmacy procedures relating to clinical trials in place, in accordance with current legislation and guidance. Oversee the development and implementation of any new procedures and trial specific dispensing procedures, and ensure all procedures are signed off, followed, reviewed and maintained.
2. To ensure all pharmacy staff involved in clinical trials are appropriately trained according to their roles, and that training records are kept and maintained.
3. To ensure relevant pharmacy staff are informed and appropriately trained with respect to new studies opening at site, including code break processes for on call pharmacists.

CLINICAL PHARMACY:

1. To be in involved with delivering and supporting pharmacy clinical services to wards when required.
2. To provide pharmaceutical advice to health care professionals, patients, carers and relatives on the wards and in other clinical areas.
3. To be involved with the clinical training of trainee pharmacists, technicians and junior pharmacists, specifically on the importance of clinical trials.
4. To be one of the authorised pharmacists within technical services if required with respect to compounding trial medications, under the direction of the Accountable Pharmacist and in accordance with Section 10 exemption of the Medicines Act 1968. To help ensure that all compounded aseptic products are compliant with relevant specifications prior to final check and release for use, and including Good Manufacturing Practice (EU GMP).
5. To participate in late clinic, late shifts, bank holiday and weekend dispensary rotas as appropriate for the staff group.
6. To be the designated pharmacists for the paediatric oncology shared care unit (POSCU). This will include attending weekly MDT and clinically screening chemotherapy prescriptions for this patient group.

MANAGERIAL RESPONSIBILITIES:

1. To ensure that all pharmacy areas associated with clinical drugs meet required standards including safety, security and complying with Health and Safety and Control Of Substances Hazardous to Health (COSHH) requirements.

1. To contribute to the development and implementation of the pharmacy element of the EDGE project management system.

1. Review departmental policies and procedures and SOPs on clinical trials.

1. To co-ordinate and liaise with Research & Innovation, the principal/investigating officers, sponsors, research nurses/practitioners, pharmacy aseptic services for the compounding of aseptic products, CRAs and individuals monitoring and auditing trials; external auditors (e.g. MHRA); all other key stakeholders as appropriate.

1. To develop and implement a capacity and contingency plan. To work with the preparative services manager to continually review workload and resources against capacity in order to develop the service, improve efficiency and patient safety, and meet challenges in expectations, demands and quality standards.

1. To ensure that robust contingency, cover and backfill arrangements are implemented during periods of planned absence.

1. To monitor and analyse trial data, develop and compile key performance indicators, statistics and provide workload intelligence against current capacity. To ensure that objectives and targets are met with respect to trial activity.

1. To manage the provision and delivery of training and competency assessment in aspects of clinical trials relevant to pharmacy staff.

PROFESSIONAL RESPONSIBILITIES:

1. To comply with legal and ethical standards in the provision of pharmacy service.

1. To ensure full compliance with UK legislation and , Good Clinical Practice (ICH GCP), Good Manufacturing Practice (GMP) where relevant and all other relevant medicines regulations and ethical requirements.

1. To manage and participate in research projects, practice research and audit.

1. Any other duties as required by the chief pharmacist or his/her deputy.

1. Contribute to the departmental continual professional development (CPD) programme and undertake CPD as required by the General Pharmaceutical Council.
2. Participate in training and development activities as considered appropriate by the Chief Pharmacist to keep up to date with advances in the service.

The post holder may be required to represent the Trust and at external meetings.

Qualifications

Essential

• Mpharm or equivalent academic qualification
• Registration with the GPhC
• Postgraduate clinical diploma/MSc equivalent or relevant experience
• Evidence of Continuous Professional Development (CPD)

Desirable

• Current membership with the Royal Pharmaceutical Society
• Independent prescriber qualification

Experience

Essential

• Post qualification experience working as a pharmacist in a clinical environment
• Experience of working in as aseptic unit in an unlicensed chemotherapy compounding unit
• Experience of clinical trials

Desirable

• Experience within both clinical and operational areas of pharmacy practice
• Clinical audit experience

Skills

Essential

• Excellent written and verbal communication
• Good interpersonal, influencing and negotiating skills
• Ability to adapt and cope with challenges
• Computer literacy
• Applied clinical knowledge
• Knowledge of aseptic procedures
• Current ICH-GCP Certificate
• Self-motivated
• Resilient, enthusiastic, diplomatic, assertive and reliable
• Good problem-solving skills

Desirable

• Excellent Information Technology skills
• Excellent organisational skills
• Working knowledge of general haematology and oncology chemotherapy protocols
• Quality control issues
• Working knowledge of e-prescribing software ARIA and Chemo-care
• Experience of the EDGE project management system

Special Requirements

Essential

• On occasion, to travel across sites to other Frimley Health NHS Foundation Trust sites

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).