Clinical Trials Specialist Pharmacist

4 days ago


Plymouth, Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time
Job Summary

We are seeking a highly motivated and experienced pharmacist to join our Clinical Trials team as a Specialist Pharmacist Clinical Trials. This is an exciting opportunity for a pharmacist to develop their skills and expertise in clinical trials, working closely with our dedicated team to deliver high-quality research studies.

Main Responsibilities
  • Assist in the coordination of pharmaceutical input into the setting-up, design, and running of clinical trials at University Hospitals Plymouth NHS Trust.
  • Act as the deputy to the lead pharmacist for the provision of Investigational Medicinal Products (IMPs) for all active clinical trials.
  • Support in the critical review of clinical trial protocols on their impact on pharmacy, packaging, labeling, and documentation.
  • Assist in the production and checking of costings for clinical trials.
  • Ensure appropriate use of IMPs within the pharmacy and support in the production and maintenance of dispensing procedures for all Clinical Trial Investigational Medicinal Products (CTIMPs).
  • Provide written instructions and training for pharmacy staff on how to dispense, label, check, handle IMPs, and perform code-breaks.
  • Liaise with the pharmacy clinical trials team to assess the impact of substantial amendments on local trial documentation.
  • Accurately screen, dispense, check prescriptions, and counsel patients regarding their medication as required in accordance with the particular study protocol.
  • Supervise the initial check and preparation of IMPs and Non-IMPs for all active clinical trials.
  • Support the pharmacy investigations into study issues and incidents involving IMPs, ensuring appropriate documentation and completion of any actions.
  • Maintain a good working relationship with sponsors, monitors, the R&D department, auditors, and regulatory authorities.
  • Ensure that the confidentiality and security of information and data about study subjects and clinical trial studies are maintained and respected.
  • Undertake and maintain a record of personal Continuing Professional Development (CPD).
  • Ensure medicines are prescribed and administered in line with local and national policies and within the legal framework.
  • Provide day-to-day supervision and support to the pharmacy clinical trials staff and rotational pharmacists working in the Pharmacy Clinical Trials.
  • Coordinate with the Clinical Trials Specialist Assistant Technical Officer the daily workload of injectable IMPs and NIMPs to the wards and departments taking clinical priority and the capacity plan for the unit into account.
  • Be on the Trust register for the release of intrathecal chemotherapy from the pharmacy department according to relevant Department of Health guidelines and local Trust policy.
  • Ensure that safe and effective systems of work are followed within the unit in compliance with the COSHH Regulations.
  • Undertake audits and engage with Quality Improvement and practice research projects.
Education and Training
  • Design and participate in training programmes for pharmacy, medical, and nursing staff, where necessary.
  • Technical supervision and mentoring of other members of ward-based staff, including pharmacists, technicians, pharmacy support assistants, and undergraduate students.
  • Provide competency-based assessment of junior pharmacists, trainee pharmacists, and pharmacy technicians and pharmacy support assistants using work-based assessment tools.
  • Train trainee pharmacists in aspects of technical and clinical pharmacy practice to meet the General Pharmaceutical Council's competency requirements, acting as an accredited educational supervisor if required.
Leadership and Management
  • Directly manage a band 6 pharmacist if required, including undertaking annual achievement reviews and monthly 1:1 meetings.
  • Assist the Advanced Specialist Pharmacists Clinical Trials in planning and implementing change management projects.
  • Assist the Advanced Specialist Pharmacists Clinical Trials in investigating any medicine/pharmaceutical-related incidents or complaints and devise ways of minimizing risk of future re-occurrence.
  • Assist the Advanced Specialist Pharmacists Clinical Trials in implementing national guidance, recommendations, and statutory requirements locally.
  • Assist in the development and maintenance of protocols and procedures in relation to pharmacy services and medicines management, including Patient Group Directions.
Research and Evaluation
  • Undertake and participate in internal and external audits and drug use evaluations within the remit of the pharmacy aseptic service and pharmacy clinical trials. Feedback audit results and implement audit action plans reporting to relevant service lines.
  • Participate in research and development, including clinical trials.
Core Pharmacy Functions
  • Participate as necessary in the on-call, weekends, Bank Holiday, and emergency duty/on-call rotas for Aseptic Services. Please note the intention to move to a 7-day service, when core duties will be distributed across a full week.
  • Clinical pharmacy services may develop to include a shift pattern or working.
  • Register and practice as a pharmacist Non-medical Prescriber (or must be willing to undertake the non-medical prescribing qualification when requested) as dictated by the needs of the service.
General Responsibilities
  • Contribute to the provision of pharmacy services across the department as appropriate.
  • Provide regular reports on and plans to develop the services provided as part of the business planning and clinical governance process.
  • Assist in the processing of high-cost drugs and homecare medicines within speciality.
  • Participate in the late duty, on-call, weekend, and bank holiday rotas.
  • Implement and contribute to Trust-wide administrative, personnel, and professional policies, where appropriate.
  • Assist other professions in maintaining current awareness in the clinical use of medicines.
  • Take responsibility for own learning and development by recognizing and taking advantage of all opportunities to learn, including full participation in appraisal system, and by maintaining a professional/personal portfolio of learning aligning with the Royal Pharmaceutical Society's Competency Framework.
  • Comply with the requirements of relevant legislation and guidelines on professional good conduct.
  • Undertake any other duties as requested by your line manager.


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