Clinical Trials Pharmacist

Job Title: Clinical Trials Pharmacist

This is an exciting opportunity for an enthusiastic and self-motivated pharmacist to join the Pharmacy Clinical Trials Team as a Band 7 Clinical Trials Pharmacist at Hampshire Hospitals NHS Foundation Trust.

About the Role

The post holder will be a member of both pharmacy clinical trials and R&D teams at Hampshire Hospital NHS Foundation trust. They will work with both teams to ensure the smooth running of clinical trials delivered at HHFT.

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

Requirements

• Support for the day to day management of the clinical trials service, monitoring key quality and performance indicators and service pressures, recommending and implementing actions to address them
• Maintaining or improving effective lines of communication between the Pharmacy and Research teams
• Senior Pharmacist, line managing designated pharmacy staff. Responsible for staff supervision, annual appraisal, managing attendance and performance, identifying and facilitating staff training needs
• Support the Business Unit through regular monthly reports and face to face interaction

Customer Care for Patients and/or Service Users

• To support the achievement of quality standards within the services and the design processes to support them, including GCP and GMP where appropriate and clinical audit
• To ensure 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
• To ensure compliance with the Trust's complaints procedure
• To deputise for the Lead Pharmacist at business unit level meetings
• Work 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
• As an advanced practitioner to comment on policies and procedures to ensure that legal and ethical requirements of the clinical pharmacy service are fulfilled and to write prescribing guidelines and standard operating procedures
• To support 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
• As clinical pharmacist, be responsible for 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
• Monitor and act 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
• Work 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
• In addition, work closely with the clinical staff, Research Department and the Divisional Management Team in the investigation of complaints and breaches and supporting the agreement, organisation and implementation of effective action plans to ensure the service has improved

Planning and Organisation

• To support delivery of the Clinical Trial Pharmacy Service to the Research Department
• To work 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. To identify reasons for deviations and support service development and implementation of potential solutions

Budgetary and Resource Management

• To be aware of and adhere to the trust's Standing Financial Instructions
• To participate in the Local Delivery Plan process in identifying budgetary requirements to deliver required access, activity, finance and quality targets
• To take responsibility for identifying and minimising areas of financial risk within the services
• To support the review of the skill mix, balance and deployment of all types of resource

Staff Management

• Ensure development and training requirements identified through the appraisal process are fed into the Trust Training & Development Programme
• Assess services/facilities and ensure that job roles are reviewed in light of any changes
• To actively promote 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

• To ensure 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
• As a clinical leader, be responsible for 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
• To motivate and inspire other staff within Pharmacy
• To develop strategies to meet the training needs of staff, ensure managed staff undergo continuing training and evaluate the training provided
• To provide 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
• To identify own training needs
• To maintain a portfolio of practice of practice to fulfil the mandatory continuing professional development requirement of The General Pharmaceutical Council
• To promote a career in hospital pharmacy by participation in the summer student placement scheme

Research and Audit

• To collect data for internal audits of the services to provide good quality assurance
• To guide and support others undertaking research
• To undertake and participate in practice research
• To publish and present research at every opportunity, within available resources

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