Senior Pharmacy Technician Clinical Trials
NHS Jobs London
Key Result Areas & Performance: Clinical Trials 1. To co-ordinate and maintain the Lewisham and Greenwich Trust Clinical Trials service in accordance with Good Clinical Practice (GCP) and departmental procedures, and ensure a high quality service is provided to patients and staff.
2. To support the Lead Clinical Trials Pharmacist in streamlining Pharmacy Clinical Trial Service across both sites at the Trust and ensure compliance to The Medicines for Human Use (Clinical Trials) Regulations/ EU Clinical Trials Directive and subsequent amendments.
3. To communicate regularly with the Research and Development (R&D) team when organising trials in set-up and delivery and ensuring compliance to local research governance. 4. To facilitate the delivery of an efficient and effective Pharmacy service for Clinical Trial patients and ensure pharmacy staff are trained specifically for each trial in accordance to GCP.
5. To dispense (or check where appropriate) clinical trials involving an IMP following procedures and recording accountability for these as necessary. 6. To manage the temperature monitoring of all IMPs in Pharmacy or other areas as appropriate by recording daily fridge and ambient temperatures 7.
To collate data for workload figures and income generation for hosting of commercial and non-commercial trials to support the Trust R&D activity. 8. To deputise for the Lead Clinical Trials Pharmacist as necessary. 9. To manage queries which arise with clinical trials in the Trust involving an IMP.
10. To facilitate the setup of all clinical trials and those in operation, working closely with the Lead Clinical Trials Pharmacist, Research Teams (Principal Investigators, Research Nurses and Sponsors), R&D and Pharmacy staff. 11. To prepare, maintain and update Standard Operating Procedures for Clinical Trials and provide comprehensive training to ensure a co-ordinated approach for the smooth running of clinical trials from a pharmacy perspective.
12. To ensure that all essential pharmacy trial documentation is maintained in accordance with the protocol and local guidelines. 13. To ensure effective stock control and maintain accurate and up to date storage and expiry records for clinical trial products and archive for future reference.
14. To facilitate stock rotation to prevent wastage 15. To be responsible for the closing of clinical trials and maintaining trial folders for archive records. 16. To provide GCP training, attend Site Initiation Visits, facilitate Monitoring Visits and be a Pharmacy representative as a point of contact for all clinical trials enquiries.
17. To report suspected or confirmed Investigational Medicinal Products (IMPs) related adverse incidents appropriately and amend local protocol if necessary. 18. To safeguard subjects, healthcare professionals and the Trust by ensuring that IMPs are appropriate for use and are procured, handled, and stored correctly.
19. To ensure that all clinical trials activities are accurately documented, and invoices for Pharmacy are processed according to local procedure. 20. To identify areas of potential cost savings relating to clinical trials service provision and work with the Lead Clinical Trials Pharmacist to action suitably.
21. To undertake audits as necessary to improve and develop the clinical trial services. 22. To liaise with external trial monitors and coordinators to ensure the smooth running of trials locally, to organise and facilitate set up meetings and monitoring visits in Pharmacy.
23. To support and address the clinical trials information and training needs of dispensary staff or other relevant individuals when planning a new clinical trial. 24. To liaise with pharmacy staff responsible for the operational aspects of clinical trials to ensure that all clinical trials activities are carried out to the highest practicable standards of GCP and Good Manufacturing Practice (GMP).
Staff Management & Training 1. To line manage staff, including: a. Providing detailed induction to new staff members in compliance with local and Trust requirements b. Regular appraisal of performance and objective setting c. To arrange and document regular 1-2-1 meetings with staff d.
To undertake return to work meetings with staff after periods of absence e. To performance manage staff where appropriate including managing sickness absence, capability issues, conduct and resolving grievance issues in line with Trust policies f.
Ensuring that all human resource policies, procedures and standards are understood and maintained g. Ensure all relevant paperwork regarding the above is up to date 2. To participate in recruitment and selection of staff. 3. To undertake health and safety risk assessments for the member of staff they manage.
4. To undertake training of pharmacy, medical and nursing staff and other members of the healthcare team as appropriate for clinical trials and to specifically ensure that all Pharmacy staff receives GCP training commensurate with their roles and responsibilities in relation to trials.
2. To support the Lead Clinical Trials Pharmacist in streamlining Pharmacy Clinical Trial Service across both sites at the Trust and ensure compliance to The Medicines for Human Use (Clinical Trials) Regulations/ EU Clinical Trials Directive and subsequent amendments.
3. To communicate regularly with the Research and Development (R&D) team when organising trials in set-up and delivery and ensuring compliance to local research governance. 4. To facilitate the delivery of an efficient and effective Pharmacy service for Clinical Trial patients and ensure pharmacy staff are trained specifically for each trial in accordance to GCP.
5. To dispense (or check where appropriate) clinical trials involving an IMP following procedures and recording accountability for these as necessary. 6. To manage the temperature monitoring of all IMPs in Pharmacy or other areas as appropriate by recording daily fridge and ambient temperatures 7.
To collate data for workload figures and income generation for hosting of commercial and non-commercial trials to support the Trust R&D activity. 8. To deputise for the Lead Clinical Trials Pharmacist as necessary. 9. To manage queries which arise with clinical trials in the Trust involving an IMP.
10. To facilitate the setup of all clinical trials and those in operation, working closely with the Lead Clinical Trials Pharmacist, Research Teams (Principal Investigators, Research Nurses and Sponsors), R&D and Pharmacy staff. 11. To prepare, maintain and update Standard Operating Procedures for Clinical Trials and provide comprehensive training to ensure a co-ordinated approach for the smooth running of clinical trials from a pharmacy perspective.
12. To ensure that all essential pharmacy trial documentation is maintained in accordance with the protocol and local guidelines. 13. To ensure effective stock control and maintain accurate and up to date storage and expiry records for clinical trial products and archive for future reference.
14. To facilitate stock rotation to prevent wastage 15. To be responsible for the closing of clinical trials and maintaining trial folders for archive records. 16. To provide GCP training, attend Site Initiation Visits, facilitate Monitoring Visits and be a Pharmacy representative as a point of contact for all clinical trials enquiries.
17. To report suspected or confirmed Investigational Medicinal Products (IMPs) related adverse incidents appropriately and amend local protocol if necessary. 18. To safeguard subjects, healthcare professionals and the Trust by ensuring that IMPs are appropriate for use and are procured, handled, and stored correctly.
19. To ensure that all clinical trials activities are accurately documented, and invoices for Pharmacy are processed according to local procedure. 20. To identify areas of potential cost savings relating to clinical trials service provision and work with the Lead Clinical Trials Pharmacist to action suitably.
21. To undertake audits as necessary to improve and develop the clinical trial services. 22. To liaise with external trial monitors and coordinators to ensure the smooth running of trials locally, to organise and facilitate set up meetings and monitoring visits in Pharmacy.
23. To support and address the clinical trials information and training needs of dispensary staff or other relevant individuals when planning a new clinical trial. 24. To liaise with pharmacy staff responsible for the operational aspects of clinical trials to ensure that all clinical trials activities are carried out to the highest practicable standards of GCP and Good Manufacturing Practice (GMP).
Staff Management & Training 1. To line manage staff, including: a. Providing detailed induction to new staff members in compliance with local and Trust requirements b. Regular appraisal of performance and objective setting c. To arrange and document regular 1-2-1 meetings with staff d.
To undertake return to work meetings with staff after periods of absence e. To performance manage staff where appropriate including managing sickness absence, capability issues, conduct and resolving grievance issues in line with Trust policies f.
Ensuring that all human resource policies, procedures and standards are understood and maintained g. Ensure all relevant paperwork regarding the above is up to date 2. To participate in recruitment and selection of staff. 3. To undertake health and safety risk assessments for the member of staff they manage.
4. To undertake training of pharmacy, medical and nursing staff and other members of the healthcare team as appropriate for clinical trials and to specifically ensure that all Pharmacy staff receives GCP training commensurate with their roles and responsibilities in relation to trials.
5. To identify own training needs, and actively seek opportunities to meet these, internal and external. To supervise and train Foundation Pharmacy Technicians, Pharmacy Technician and Assistants by being a Practice Supervisor or working towards this accreditation
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