Senior Ato Clinical Trials and Production Services

4 months ago

Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time

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. 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. 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.

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. To record clinical trial drugs returned by the patients on appropriate drug accountability records and dispose of them according to the trial. To assist in the close-down and archiving of completed clinical trials. Organise trial monitor visits ensuring that both the pharmacy site files are drug returns are prepared in advance.

To respond quickly and appropriately to all enquiries and queries, directing to most appropriate team member. To use the pharmacy computer and related technologies according to the needs of the department. To participate in the ordering and receipt of clinical trials products following trial protocols, study specific instructions and the departmental SOPs. 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.

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. To ensure that pharmacy trial store and equipment is kept in a clean and usable workable condition. To attend GCP training/sessions as appropriate and to work to GCP at all times. To participate in the appraisal process and to undertake appropriate mandatory training.

To assist with training of the ATO and other pharmacy staff as required in dispensing clinical trials. To participate in audit projects to review clinical trial processes. To contribute and assist with advice to pharmacy staff about clinical trials. To participate in the departmental training programme including NVQ Level II.

To be able to adhere to Standard Operational Procedures and policies without supervision To participate and maintain a record of continuing personal and professional development. For further details please see attached JD&PS.

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