Highly Specialist Pharmacist, Clinical Trials

Job responsibilities

Key results from the job holder

Key Responsibilities

Clinical Trials Governance & Compliance

Ensure the pharmacy clinical trials service operates safely, efficiently and in full compliance with EU and UK legislation

Maintain operational compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, EU Directive 2001/20/EC, ICH Good Clinical Practice (GCP) guidelines, and professional standards.

Provide specialist support during MHRA Good Clinical Practice (GCP) inspections, ensuring timely access to documentation and evidence of compliance.

Strategic & Professional Leadership

Align pharmacy clinical trials services with the Trusts Research & Innovation Strategy and the Pharmacy and Medicines Management Services Strategy.

Provide professional leadership to Clinical Trials Pharmacy staff to ensure accuracy, quality, and compliance with regulatory standards.

Advise the Trusts R&I Division and Clinical Trial Principal Investigators on IMP manufacture, procurement, storage, distribution, and all relevant legislation.

Operational Delivery

Oversee the building and validation of clinical trial medicines and protocols within the Trusts electronic prescribing system.

Work with Procurement to source unavailable medicines and identify suitable clinical alternatives to support patient treatment.

Collaborate with the Governance team to ensure appropriate cover for medicines information and medication safety queries, particularly during national patient safety alerts.

To be a non-medical prescriber.

Develop, implement and audit unit wide policies, procedures and guidelines related to medication prescribing, supply, administration or disposal. Publish findings and undertake pharmacy practice research.

Ensure compliance with medicines management guidance issued by the Trust, GMMMG or national bodies.

Ensure compliance with Medicines Law and CQC requirements.

Planning and Organisational Duties

As part of the Clinical Pharmacy Team, to be responsible for the provision of Clinical Pharmacy Services to patients.

To have a commitment to dispensaries and to deliver the highest possible professional standards therein.

In absence of a more senior Pharmacist to take professional responsibility for the dispensary including supervision of technicians, assistants and pre-registration pharmacists.

Prioritise patients according to their clinical and pharmaceutical need.

Obtain, validate & reconcile patient medication histories.

To use clinical tests and patient notes to advise clinicians about required changes to patient medication and alternatives that may be suggested if the normal route of administration is unavailable.

Analyse medicine charts taking into account the clinical presentation of the patient, any relevant history and plans made by clinicians.

Make appropriate endorsements in line with relevant standards.

Ensure VTE compliance has been undertaken where appropriate.

Ensure antimicrobials are prescribed in line with current trust guidance.

In conjunction with the medicines management technicians to ensure patient specific medicines are ordered.

Ensure the effective re-use of patients own drugs.

If deemed unfit for re-use to destroy medicines ensuring relevant procedures are followed.

To receive, interpret, clinically check, dispense, accuracy check and handout prescriptions in line with departmental standard operating procedures.

Ensure pharmacy stock is controlled effectively. To assist in the ordering, issuing and receiving of medication when necessary.

Participate in clinical trials ensuring relevant details are maintained in trials documentation.

Ensure ward Controlled Drugs and other departmental audits are completed to the prescribed schedule.

Communications and Key Working Relationships

Using professional judgement and in a professional manner, to communicate to patients, carers and healthcare staff any appropriate information about medicines which make their use safer or more effective.

Assist other health professionals on wards to deliver the highest standards of care.

Liaise with other members of the pharmacy team to ensure clinically effective services are provided.

Refer to more senior pharmacists in team when appropriate.

Provide ward cover for other clinical teams or for more senior colleagues within the team.

To develop effective working relationships with other healthcare professionals within area of responsibility.

Responsibility for Finance

Assist delivery of cost efficiencies, by advising how medicines should be used in line with locally agreed formularies or guidance.

Handle cash, prescription charges & issue relevant receipts in line with trust SFI.

Sign orders for pharmaceutical products including controlled drugs in the absence of a more senior pharmacist.

Responsibility for Human Resources

Organise own work patterns within framework provided by line manager, demonstrating leadership qualities at all times.

Deputise for Principal Pharmacist where necessary.

Supervise and motivate clinical pharmacists, pre-registration pharmacists, pharmacy technicians and assistants.

Ensure staff have an understanding of & implement relevant procedures.

Suggest improvements to procedures through line management.

Responsibility for Health & Safety

Compliance with the Health & Safety at Work Act 1974 the post holder is required to fulfil a proactive role towards the management of risk in all of their actions. This entails the risk assessment of all situations, the taking of appropriate actions and reporting of all incidents, near misses and hazards, and a statutory duty of care for their own personal safety and that of others who may be affected by their acts or omissions.

Ensure patients and staff are advised of risks with medicines and to minimise those risks through effective medicines management support and counselling.

Ensure known risks are brought to attention of line managers.

Ensure Datix is used to record and review medicines related incidents. In conjunction with Managers to ensure appropriate systems are put in place to prevent recurrence where possible.

Responsibility for Teaching

Develop and deliver training packages ensuring they are relevant to all staff involved in the prescribing, supply, administration and handling of medicines.

Provide teaching sessions to other healthcare professionals in line with knowledge and experience. To teach pre-registration pharmacists bearing in mind the expectations of the GPC and pre-registration tutor.

Knowledge

Essential

• Broad academic/theoretical knowledge to support all of the required experience
• Knowledge of NHS National policy & key changes in the NHS
• Understanding of Trust Values and Strategy

Skills

Essential

• Innovative clinical pharmacy practice using analytical / problem solving skills in complex situations
• Able to assertively / enthusiatically lead, engage, motivate and inspire staff within and outside of pharmacy team
• Highly effective interpersonal and communication skills
• Able to assess and manipulate a broad range of information quickly and accurately
• Able to make effective judgements based on limited information
• Computer Skills
• Ability to manage time, prioritising tasks to meet deadlines.
• Highly effective interpersonal & communication skills.

Experience

Essential

• Extensive clinical pharmacy experience and service delivery as part of MDT at minimum of band 7 / Specialist level
• Previous Clinical Trials or Research experience.
• Trial set up and file management experience
• Recent experience of governance and assurance at departmental level
• Recent experience of assisting a successful senior pharmacy team to achieve objectives
• Recent experience of successfully delivering change.
• Clinical mentoring or pre-registration tutor
• Lead projects / audit in co-operation with others.
• Experience of audit and reporting.
• Experience of training and education.
• Fully understands context in which complex problems arise and can co-ordinate multidisciplinary solutions
• NHS management experience including experience of managing staff, workload and monitoring quality
• Shows that they deliver high quality patient care, appropriate to the needs and expectations of patients and their relatives
• Experience in the clinical speciality

Qualifications

Essential

• Masters Degree in Pharmacy plus successful completion of pre-registration training year ( or earlier equivalent. )
• Diploma/MSc in Clinical Pharmacy or equivalent
• Membership of the General Pharmaceutical Council.
• Evidence of CPD in line with GPhC requirements
• Prescribing Qualification

Additional

Essential

• Enthusiasm for the post & for pharmacy
• Professional credibility with all levels of staff
• Speak English to an appropriate standard relevant to their role, i.e. with confidence and accuracy, using correct sentence structures and vocabulary, and without hesitation.
• Evidence of CPD in line with GPhC requirements

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).