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Clinical Trials Pharmacist

2 months ago

Winchester, Hampshire, United Kingdom Hampshire Hospitals NHS Foundation Trust Full time

Job Title: Advanced Pharmacist Clinical Trials

Job Summary:

We are seeking an experienced and skilled pharmacist to join our Pharmacy Clinical Trials Team as a Band 7 Clinical Trials Pharmacist. The successful candidate will be responsible for ensuring the smooth running of clinical trials delivered at Hampshire Hospitals NHS Foundation Trust.

Key Responsibilities:

  • Project management and meeting deadlines
  • Creating and maintaining bespoke pharmacy specific documentation for each trial
  • Reviewing sponsor documents and collaborating with sponsors, contract research organisations (CROs) and research teams
  • Participating in all aspects of Pharmacy Clinical Trial from setup to close down
  • Providing updates on pharmaceutical aspects of trials to ensure alignment with project goals
  • Co-ordinating and delivering Pharmacy support to Researchers at HHFT
  • Working with the dedicated Clinical Trial Team, to plan workload for Pharmacy Services for the Trust and ensure operational implementation
  • Ensuring that Pharmacy procedures relating to clinical trials involving (IMPs) are in accordance with existing regulations and with Research Governance Framework
  • Providing highly specialised professional expertise to Researchers in the development of clinical trial protocols involving medication and related substances and to provide advice & information regarding the application for Clinical Trial Authorisation certification from the MHRA
  • Supporting other members of the clinical trial pharmacy and R&D teams
  • Participating in any 7-day shift pattern as required by the service which may include weekend and Bank Holiday rotas

Customer Care for Patients and/or Service Users:

  • Supporting the achievement of quality standards within the services and the design processes to support them, including GCP and GMP where appropriate and clinical audit
  • Ensuring the clinical trials service is proactive in risk management, specifically using information from audits, inspections as well as incidents, complaints and risk assessments to learn and improve
  • Ensuring compliance with the Trust's complaints procedure
  • Deputising for the Lead Pharmacist at business unit level meetings
  • Working with the corporate Clinical Governance Team and Research Department to ensure robust systems and programmes are established within the services to monitor and deliver clinically effective high quality services
  • Commenting on policies and procedures to ensure that legal and ethical requirements of the clinical pharmacy service are fulfilled and writing prescribing guidelines and standard operating procedures
  • Supporting the organisational management of service improvement projects or initiatives for the service, development of project plans, and delivery of aims and objectives of each individual project
  • Providing leadership to and development of staff within the defined clinical areas to ensure that patients receive a positive care experience that meets the standards laid out in current and future national and professional guidance such as National Institute of Clinical Excellence (NICE) guidelines and clinical network recommendations
  • Working with the clinical staff to ensure staff are professionally developed in order to comply with Trust policies and procedures of practice
  • Monitoring and acting upon all reports of adverse events that are a result of patients entering clinical studies, ensuring necessary changes in practice, re-education of staff and sharing of the experience takes place within the investigating team and Trust to help prevent similar events from taking place
  • Working with the Patient Advocacy Liaison Service (PALS) to support patients and relatives in the speedy and satisfactory resolution of queries and complaints about the service
  • Investigating complaints and breaches and supporting the agreement, organisation and implementation of effective action plans to ensure the service has improved

Planning and Organisation:

  • Supporting delivery of the Clinical Trial Pharmacy Service to the Research Department
  • Working with the Research Department and Pharmacy Team, internal & external customers to ensure effective planning, scheduling, delivery and monitoring of service access, activity and quality targets

Budgetary and Resource Management:

  • Aware of and adhering to the trust's Standing Financial Instructions
  • Participating in the Local Delivery Plan process in identifying budgetary requirements to deliver required access, activity, finance and quality targets
  • Taking responsibility for identifying and minimising areas of financial risk within the services
  • Supporting the review of the skill mix, balance and deployment of all types of resource

Staff Management:

  • Ensuring development and training requirements identified through the appraisal process are fed into the Trust Training & Development Programme
  • Assessing services/facilities and ensuring that job roles are reviewed in light of any changes
  • Actively promoting diversity, including race diversity, both in the delivery of the sections and in the recruitment, management and development of staff within the directorate

Teaching, Training and Research Responsibilities:

  • Ensuring new staff receive a full induction, and those in training positions have the necessary training provided to ensure they achieve the competencies required for the qualification for which they are studying
  • Providing leadership to and development of staff within the area of Research to ensure that patients receive a positive care experience that meets the standards laid out in current and future national and professional guidance such as National Institute of Clinical Excellence (NICE) guidelines and clinical network recommendations
  • Motivating and inspiring other staff within Pharmacy
  • Developing strategies to meet the training needs of staff, ensuring managed staff undergo continuing training and evaluating the training provided
  • Providing training to Pharmacists, pre-registration pharmacy graduates, pharmacy technicians, summer students and other healthcare professionals with respect to the care of patients and medicines optimisation within clinical trials
  • Identifying own training needs
  • Maintaining a portfolio of practice of practice to fulfil the mandatory continuing professional development requirement of The General Pharmaceutical Council
  • Promoting a career in hospital pharmacy by participation in the summer student placement scheme

Research and Audit:

  • Collecting data for internal audits of the services to provide good quality assurance
  • Guiding and supporting others undertaking research
  • Undertaking and participating in practice research
  • Publishing and presenting research at every opportunity, within available resources