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Detailed job description and main responsibilities

Technical role:

To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic dispensing.

To provide specialist technical advice to service users as necessary e.g. suitability of diluents, volume of diluents, administration routes and stability data.

To partake in the rota where required, and perform specific tasks related to the preparation of an aseptic product such as completion of product worksheets, assembly of medicines and consumables, aseptic dispensing, packing prepared medicines for transport.

To perform pre and in-process checks of aseptically prepared products having undergone the appropriate accreditation.  

To ensure finished products are transported appropriately according to any physical and regulatory requirements.

To ensure clean room and isolator cleaning standards, and to participate in the clean room/isolator cleaning rota as required.

To be responsible for ensuring that expiry date and stock level checks are carried out.

To ensure maintenance of departmental records including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.

To work collaboratively with Pharmacy Purchasing and Distribution Unit (PPDU) and OUH procurement team to oversee purchasing and distribution for the CTASU.

To liaise with external and internal suppliers of stock, consumables, equipment etc.

To be responsible for the preparation of rotas for CTASU staff and collaborate with other operational managers to always ensure the most effective deployment of staff.

To identify and monitor the needs of service users and CTASU, and effectively plan and implement changes and improvements to the CTASU.

To support the development and commissioning of new equipment, processes or facilities through agreed SOPs and Change Control procedures.

Management:

To be responsible for the supervision and day to day management of staff within the CTASU.

To line manage technical CTASU staff.

To ensure all staff in the CTASU are appraised at least annually in line with OUH policy, and personal development plan and participate in Continuous Professional Development, including competency frameworks as appropriate.

To ensure staff maintain statutory and mandatory training to meet Trust requirements.

To work with the Lead Pharmacist for Education and Training and other senior staff to ensure individual training and educational needs of staff are identified and met through a programme of Continuous Professional Development; including the use of competency frameworks where appropriate.

Clinical Trials

To ensure all CTASU staff are in compliance with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP.

To ensure all members of the CTASU staff have appropriate ICH-GCP training.

To work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directive relating to Clinical Trials.

To communicate with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial.

To oversee the production, implementation and review of detailed written pharmacy guidance and SOP’s for each clinical trial in accordance regulatory standards and each trial’s protocol.

To ensure clinical trial protocols are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol.

To maintain clinical trial filing systems and drug accountability documentation for clinical trials.

To support the training of medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials.

To liaise with other centres for clinical research to ensure common standards of practice.

To assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.

Teaching and Training

To be an accredited Pre and In Process Checker

To support in the planning, writing and delivery of training programmes for staff in CTASU, ensuring that training folders are up to date and valid.

To support the Pre and In Process checking programme for pharmacy technicians in the CTASU, in liaison with the Pharmacy Education and Training Team.

To co-ordinate the training for rotational staff such as clinical trial team, cancer team, pre-registration technician and pre-registration pharmacists.

To work closely with the Pharmacy Education and Development team to ensure all CTASU staff are trained and competent and comply with mandatory training requirements.

To be aware of training and competency assessment of pre-registration pharmacists, diploma pharmacists, student pharmacy technicians and apprentices, and participate in their training and competency assessment as required.

To work with the technician training team to ensure all CTASU staff are released for mandatory training, and CTASU staff contribute as required to training and competency assessment of pharmacy staff as required.

General responsibilities

To maintain registration with General Pharmaceutical Council and uphold the professional standards

To ensure confidentiality is maintained at all times.

To use experience and clinical judgment to assist in problem solving and trouble-shooting.

To be professionally accountable for actions and advice.

To collect evidence to deal with complaints in accordance with the Trust’s complaints policy.

To be first point of contact for operational issues, queries and concerns.

To represent CTASU at departmental and Trust meetings.

To participate in week day service starting at 07:00, weekend, evening and bank holiday working according to rota.

Any other reasonable duties as requested by the Clinical Director of Pharmacy and Sterile Services or line manager.