Specialist Pharmacist Clinical Trials Specialist

2 months ago

Plymouth, Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time
About the Role

We are seeking a highly skilled and motivated pharmacist to join our Clinical Trials team at University Hospitals Plymouth NHS Trust. As a Specialist Pharmacist Clinical Trials, you will play a key role in ensuring the safe and effective management of clinical trials within our trust.

Key Responsibilities
  1. Assist in the coordination of pharmaceutical input into the setting-up, design, and running of clinical trials at the UHPNT, working closely with pharmacy, nursing, and medical staff and the R&D department.
  2. Act as the deputy to the lead pharmacist for the provision of Investigational Medicinal Products (IMPs) for all active clinical trials.
  3. Support the critical review of clinical trial protocols on their impact on pharmacy, packaging, labeling, and documentation, incorporating further comments from appropriate specialist clinical and production services pharmacists where required.
  4. Assist the Pharmacy Clinical Trials Team in producing and checking costings for clinical trials where necessary.
  5. Ensure the accurate screening, dispensing, checking, and counseling of patients regarding their medication as required in accordance with the particular study protocol.
  6. Supervise the initial check and preparation of IMPs and Non-IMPs for all active clinical trials, undertaking the final check for these products made under section 37 exemption of the Medicines for Human Use (Clinical Trials) Regulation 2004.
  7. Support the pharmacy investigations into study issues and incidents involving IMPs, ensuring appropriate documentation and completion of any actions.
  8. Maintain a good working relationship with sponsors, monitors, the R&D department, auditors, and regulatory authorities.
  9. Ensure the confidentiality and security of information and data about study subjects and clinical trial studies are maintained and respected.
  10. Undertake and maintain a record of personal Continuing Professional Development (CPD).
  11. Ensure medicines are prescribed and administered in line with local and national policies, and within the legal framework.
  12. Provide day-to-day supervision and support to the pharmacy clinical trials staff and rotational pharmacists working in the Pharmacy Clinical Trials.
  13. 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.
  14. 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.
  15. Ensure that safe and effective systems of work are followed within the unit in compliance with the COSHH (1988) Regulations.
  16. Undertake audits and engage with Quality Improvement and practice research projects.
Requirements
  • Master's Degree (or equivalent) in Pharmacy.
  • Current registration with the General Pharmaceutical Council.
  • Non-medical prescriber (or must be willing to undertake this when requested).
  • Post Graduate Certificate in Clinical Pharmacy or Equivalent.
  • Working towards a Post graduate Diploma in Clinical Pharmacy or equivalent, PTQA (must have certificate level).
Desirable
  • Master's degree in oncology/haematology, or Pharmaceutical Technology and Quality Assurance.
  • Management training.
  • ICH GCP training.
  • Member of the United Kingdom Clinical Pharmacy Association (UKCPA)/Royal Pharmaceutical Society (RPS)/British Oncology Pharmacy Association (BOPA).

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