Clinical Trials Pharmacist

Job responsibilities

DUTIES AND RESPONSIBILITIES

Clinical Trials

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 Clinical Trials Resource Group.

To monitor, document and advise on the financial implications of designated studies to the Senior Pharmacists for Clinical Trials, R&D, 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, Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU directive 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&D staff as required.

Act as a resource for staff within R&D 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.

Qualifications

Essential

• Masters Degree in Pharmacy or equivalent
• Completion of pre-registration training
• Registered with GPhC
• Evidence of continuing professional development

Desirable

• Clinical trials experience
• Diploma in clinical pharmacy or relevant postgraduate qualification
• Membership of Royal Pharmaceutical Society

Experience

Essential

• Experience of providing medicines information and advice
• Experience of service improvement/project management

Desirable

• Experience of working within a hospital environment
• Experience within the oncology field
• Knowledge and understanding of the principles and regulations underlying aseptic services
• Staff supervision & training

Skills

Essential

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

Desirable

• Understanding of the skills required within aseptic services

Knowledge

Essential

• NHS Cancer Plan, NICE
• Excellent knowledge of clinical use of medicines
• Cost-effective use of medicines and medicines management

Desirable

• Knowledge of drug use in oncology
• Knowledge of procedures within an aseptic unit
• GCP/GMP
• Financial awareness
• National Intrathecal guidelines

Values

Essential

• Ability to demonstrate the organisational values and behaviours

Other

Essential

• Emergency on call commitment
• Bank holiday working
• Flexible working hours

Desirable

• Driver'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).