Adv Clinical Pharmacist - Clinical Trials

Job description

Job responsibilities

2. JOB PURPOSE

To lead, deliver, develop and evaluate highly specialised clinical pharmacy services to a clinical speciality within the Trust

3. JOB DIMENSIONS

Leads the highly specialised clinical pharmacy service to patients and the multidisciplinary team within a given clinical speciality. Ensures medicines are used appropriately, safely, and cost effectively in accordance with Trust policy, standard operating procedures and medicine legislation. The post holder is expected to determine how the outcomes are best achieved in specific circumstances.

Manage other pharmacists providing specialised clinical pharmacy service within own clinical speciality depending on size of area.

Works directly and regularly with consultants, senior nursing staff and managers within the clinical speciality. Monitors and interprets expenditure on medicines within own clinical speciality. Provides the Directorate with regular reports to assist in the safe use of medicines, the management of the drug budget and clinical governance issues. The report also includes risk management such as the recording of significant clinical interventions and near misses.

Supervise, along with other members of their multidisciplinary team, the development and implementation of treatment protocols, and guidelines for use of drugs within the clinical area.

Responsible for training pharmacists, and other health care professionals, on aspects of drug use within the clinical area.

Provides minimum of at least one 4 hour session of service cover in the dispensary or aseptic dispensary each week. Participates in evening, weekend and bank holiday rota and where appropriate, out of hours services.

To act as the Responsible Pharmacist in line with local procedures.

SPECIFIC DUTIES FOR CLINICAL TRIALS

Provide advice and information in relation to all medicines related aspects of R and I activities, including clinical trials, within the Trust to ensure compliance with national legislation and guidelines.

Review and improve current Medicines Management and Pharmacy Services CSU MMPS clinical trial set up processes to provide a service that meets the Trusts performance in initiation and delivery targets for NIHR portfolio clinical trials.

Provide support and advice to ACPs and rotational pharmacists in the review of new protocols. Liaise with aseptics, investigators, trial sponsors and Trust R&I regarding medicines management issues raised as part of the review.

Check and approve final versions of IMP (investigational medicinal product) management procedures for each trial. Perform the Pharmacy Green Light process for Clinical Trials

Ensure that current Pharmacy Clinical Trial Standard Operating Procedures (SOPs) are applicable and comply with Good Clinical Practice and the requirements of the UK Clinical Trial Regulations. Write, update or amend in conjunction with the Clinical Trials Management Team as necessary

Assist the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies and regulatory agencies.

Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies and procedures relating to clinical trials.

Line manage Band 7 pharmacists working within the Clinical Trials team.

Contribute to service development and quality improvement strategies in line with the Leeds Improvement Method.

Use local and national networking opportunities to promote the LTHT clinical trials service to a wider audience.

To provide cover for Trust R&I governance, education and prioritisation meetings and have close liaison with the clinical research teams.

SPECIFIC DUTIES FOR ASEPTIC SERVICES

To provide professional supervision and release of products in Aseptic and radiopharmacy dispensaries

To support the Aseptic Service Manager in the delivery, management and development of the pharmacy Aseptic Dispensing service across the Trust, ensuring that legislative and statutory controls are met and that the service supports high quality patient care through cost effective and responsive aseptic dispensing units

To be responsible for induction and training in matters related to Parenteral Therapy to both pharmacy staff and other health care professionals as required.

To provide pharmaceutical care to patients in defined clinical areas

Other

Provide a service commitment, typically a four hour session to a specific area within the pharmacy department e.g. dispensary, aseptics or medicines information

Perform other duties as directed by manager

Participate in the weekend service and where contracted, the emergency duty service

KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED

Masters qualification in Pharmacy (4 years) or equivalent qualification plus one year pre-registration experience

Registrant of the General Pharmaceutical Council (GPhC)

Postgraduate diploma in Clinical Pharmacy or equivalent experience or qualification

Non medical prescriber status is preferred.

Substantial post registration experience as a practising clinical pharmacist. Ability to demonstrate foundation level competencies in all 6 domains of the Advanced to Consultant Level Framework (ACLF)

Experience of dealing with highly complex clinical issues which require the pharmacist to analyse information from a range of sources, which may not be in agreement, to formulate a response. In such situations, it may be necessary to find a novel solution to an unusual clinical situation. The pharmacist will have developed negotiating and persuasive skills with other clinical team members, patients and relatives

Experience of dealing with a wide variety and grade of hospital staff (including senior medical and managerial staff) on a regular and ongoing basis

Specialist knowledge of clinical area/department which demonstrates ability to manage a caseload, preferably within the clinical speciality

Considerable experience in hospital pharmacy and aseptic dispensing/processing

Specialist knowledge of and training in Aseptic Dispensing and Quality Assurance

CORE BEHAVIOURS AND SKILLS

Leadership

Interpretation of financial information

Team player

Enthusiastic

Lateral thinker

Excellent communication - oral/written/listening

Good problem solver

Good time management skills

Adaptable

Able to use initiative

Highly developed negotiation and influencing skills

Meticulous attention to detail

The individual will organise their own work and potentially that of others in the specialist service on an on going basis e.g. training, audit, project work, attendance of meetings, own ward cover etc

Person Specification

Qualifications

Essential

• Post graduate diploma in clinical pharmacy

Desirable

• Good Clinical Practice Training

Skills & behaviours

Essential

• Team player
• Prioritisation and Time management
• Meticulous attention to detail
• Able to work under own initiative
• Excellent influencing and negotiating skills

Desirable

• Mentoring skills

Experience

Essential

• Knowledge and application of good clinical practice
• Knowledge and application of good manufacturing practice and quality assurance
• Foundation level competency in all Advanced Pharmacy Framework (APF) domains

Desirable

• Experience in radiopharmacy

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).

Employer details

Employer name

Leeds Teaching Hospitals

Address

Leeds General Infirmary

Great George Street

Leeds

LS1 3EX

Employer's website

https://www.leedsth.nhs.uk/ (Opens in a new tab)