Clinical Trials Pharmacy Technician

Job description Job responsibilities 1. Working with the Lead Pharmacist of Clinical Trials and Quality Assurance, to provide a comprehensive Clinical Trials service which: a. Ensures that all processes and documentation are completed in line with UK legislation (The Medicines for Human Use (Clinical Trials) Regulations 2004) and associated amendments. b. Ensures that Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidance is followed when dispensing and managing Clinical Trials that involve Investigational Medicinal Products (IMPs). c. Ensures that safe dispensing practices are applied and adhered to at all times when dispensing and preparing Investigational Medicinal Products (IMPs). d. Provides a Clinical Trial prescription screening service and final checking to ensure that the service is efficient, effective and safe in accordance with the particular study protocol. e. Ensures that the safety, quality and professionalism of the service is maintained and complies with the required standards at all times. f. Manages and resolves any clinical or dispensing queries relating to Clinical Trials prescriptions and Clinical Trial Protocols / Pharmacy SOPs relating to protocols. g. Works with other Principal / Lead Pharmacists to engage them in the Clinical Trials Service and ensure resilience within the service. 2. To contribute to the provision of Pharmacy Clinical Trials service with individual clinical service lines, Research and Development (R&D) department and across the Trust: a. To attend the R&D meetings. b. To attend site selection, as necessary, as well as initiation and set up meetings for individual trials. 3. To oversee and support the pharmacy team in Clinical Trial set-up and provide continued support for the running and maintenance of current trial activity. This will include the generation and revision (following protocol amendments) of local study specific protocol summaries. 4. To provide pharmaceutical Clinical Trial support and advice to R&D staff (including clinical research nurses and consultants) conducting all CTIMP studies, commercial and non-commercial, to enable good IMP management and patient safety. 5. To work with the Pharmacy Clinical Trials team in the identification, development, review, and revision of new standard operating procedures SOPs which cover the Clinical Trials activities within that department. 6. To evaluate the Pharmacy Clinical Trials service in conjunction with the Lead Pharmacist for Clinical Trials and contribute to service improvements within the Pharmacy department to promote the role of Pharmacy in the overall conduct of Clinical Trials across the Trust. 7. Prepare documentation for the pharmacy site file including dispensing guidelines, worksheets, ensuring conformity with requirements of protocol. 8. Ensure ongoing monitoring of pharmacy site files is undertaken, ensuring accurate completion of records. 9. Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to. 10. Ensure effective systems and procedures are utilised to cover all stages of the drug accountability process: order, receipt, storage, issue, returns and disposal/destruction. 11. To order and receive clinical trial supplies as necessary and ensure appropriate records are kept. 12. Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to. 13. To maintain an orderly and suitable inventory of all pharmacy clinical trials in the appropriate storage area. 14. To manage the security and maintenance of all clinical trial drugs. 15. To arrange for the disposal or return of stock at the end of a trial, or when drugs pass their expiry dates as per procedure. 16. Ensure correct procedure for quarantine is followed and documented for all drugs affected. 17. Upon trial termination, ensure pharmacy close-out and archiving is carried out in line with regulatory and contractual requirements. 18. Participate in regular audits and reviews of clinical trials, clinical trial standards and processes in particular relating to clinical trial practice and activity. Other 1. Maintain knowledge of current regulatory guidelines and regulations pertaining to requirements for this post. 2. To ensure confidentiality is maintained at all times. 3. To be responsible for delivery against agreed deadlines. 4. To be able to respond quickly to variations and problems as they arise. 5. To participate in the education and training of the pharmacy team, other healthcare professionals and patients as appropriate. 6. To undertake other duties as reasonably requested by the Head of Pharmacy (LDH) or the Director for Research and Development. 7. To carry out the professional responsibilities of a pharmacy technician in accordance with the General Pharmaceutical Council. 8. To participate fully in the individual performance review and objective setting process of the Trust.