To assist the Clinical Trials and Research Pharmacist in all aspects of clinical trials and ensure compliance with current national legislation, the International Conference of Harmonisation Good Clinical Practice (ICH GCP) guidance and the Research Governance Framework (2005) in the conduct of clinical research.
Undertake technical duties in the preparation of manufactured pharmaceuticals within the Pharmacy Production Services to ensure all research products are prepared to a high standard as set out in study specific documents, standard operating procedures and appropriate guidelines.
For further information, please contact:
Mike Marner
Pharmacy Trial Manager
[email protected]
01752 432280
- To prepare in the clean room environment aseptically manufactured high risk pharmaceuticals including cytotoxic drugs, monoclonal antibodies, antibiotics and other intravenous additives.
- To maintain, in conjunction with the Pharmacy Clinical Trials team, a high standard of service to patients, wards, departments, investigators, research nurses and pharmaceutical companies.
- To work with other members of the pharmacy and research team to ensure that the rights, safety and well-being of trial participants are protected.
- To support the pharmacy clinical trial team by contribution to dispensing clinical trials material in accordance with study specific dispensing procedures.
- To support the pharmacy clinical trial team by contribution to monitoring visit, administrative support, record keeping, archiving and maintenance of study specific documentation.
***Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.***
We are a people business – where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment manager for this post who will put you in touch with the recruitment team. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
PRIMARY DUTIES & AREAS OF RESPONSIBILITY
1. To prepare and prioritise cancer chemotherapy and medicines for injection including GMO class 1 and 2, using laminar airflow cabinets or isolator technology, providing all necessary in-process checks, within the clean room environment under the guidance of good manufacturing practice.
2. To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local trust policy and departmental procedures.
3. To work unsupervised if necessary in the preparation of cancer chemotherapy.
4. To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice legislation and guidelines.
5. To prepare all types of product documentation, with all types of calculations and the production of labels using the Prisym 2000 label software.
6. To assemble the raw materials and consumables required to prepare each individual product, ensuring total segregation of each preparation using a box or tray segregation system as defined in the standard operating procedure.
7. To assist with Clinical Trial stock control to include the production and checking of routine stock checks, ensuring stock rotation and expiry date checks are completed and investigating stock discrepancies.
8. To complete, maintain and file all relevant documents, records and reports.
9. To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out.
10. To co-operate and participate in any training and development in production services, attending such study days and courses as necessary for service development.
11. To complete any environmental monitoring or operator validation tests requested by the quality assurance manager as appropriate to Clinical Trials.
12. To provide effective communication with the R&D department, the research team, multidisciplinary team and various UK organisations and pharmaceutical companies.
13. To undertake general dispensary duties, in accordance with standard operating procedures and the legal framework for the supply of medicines:
Labelling - generate accurate medication labels
Dispensing - accurately dispense inpatient, outpatient and discharge prescriptions, including clinical trials, cytotoxic drugs and controlled drugs.
Issue drugs - to healthcare professionals referring for advice when necessary.
14. In collaboration with the pharmacy clinical trials team to ensure accurate record keeping of drug accountability of all clinical trials (both written and computer records). Reporting any exceptions of deficiencies to the pharmacy clinical trials support manager.
15. To contribute to the efficient stock control of all clinical trial products by undertaking regular stock checks to ensure sufficient (IMP/trial-specific) “in date” stock for current and new patients.
16. To record clinical trial drugs returned by the patients on appropriate drug accountability records and dispose of them according to the trial.
17. To assist in the ‘close-down’ and archiving of completed clinical trials.
18. Organise trial monitor visits ensuring that both the pharmacy site files are drug returns are prepared in advance.
19. To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member.
20. To use the pharmacy computer and related technologies according to the needs of the department.
21. To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs.
22. To ensure that all trials are run in accordance with GCP, Good Manufacturing Practice and Good Dispensing Practice guidelines/department procedures and reporting any deviations to the pharmacy clinical trials support manager.
23. To monitor appropriate storage of all clinical trial products ensuring storage condition records and accurate expiry records for all clinical trial products are kept up to date and archived for future reference according to GCP, GMP Guidelines.
24. To ensure that pharmacy trial store and equipment is kept in a clean and usable workable condition.
25. To attend GCP training/sessions as appropriate and to work to GCP at all times.
26. To participate in the appraisal process and to undertake appropriate mandatory training.
27. To assist with training of the ATO and other pharmacy staff as required in dispensing clinical trials.
28. To participate in audit projects to review clinical trial processes.
29. To contribute and assist with advice to pharmacy staff about clinical trials.
30. To participate in the departmental training programme including NVQ Level II.
31. To be able to adhere to Standard Operational Procedures and policies without supervision
32. To participate and maintain a record of continuing personal and professional development.
