Pharmacy Clinical Trials

2 weeks ago

Oxford, United Kingdom Oxford University NHS Foundation Trust Full time

Core Role - Clinical Trials Set up trial specific study files and generate all necessary essential pharmacy documentation, in preparation for pharmacy sign off. Attend multidisciplinary team meetings with investigators to initiate, manage and close down trials hence ensuring pharmacy participation. Undertake a review of a clinical trial if an amendment is issued. Progress the amendment in accordance with SOPs to ready for Pharmacy Green Light approval.

Ability to manage own workload and plan activities to ensure trial set up and amendment timelines can be met. Work with colleagues in the Clinical Trials Team to assist in planning the workload for Set-up of new trials and amendments in accordance with R&D Monthly Lists. Ensure good communication with Investigators, Research Nurses, Trust Research & Development, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial. Provide appropriate teams with complex and detailed information regarding the pharmacy aspects of the trial, showing high levels of understanding of aspects of pharmacy processes.

Be able to discuss complex issues in a trial and resolve them by explanation and persuasive skills. Maintain personal expertise, skills and necessary knowledge of the regulations and requirements for Clinical Trials as developed through training and experience developed through degree level training. Using knowledge and skills developed through training, compare different options of how a trial could be run and set up and make a judgement on the best route to take. Seek advice and support appropriately from senior colleagues to facilitate timely set-up and plan when studies will be ready for review & Pharmacy Green Light approval.

Liaise with other centres for clinical research to ensure common standards of practice. Participate in implementing changes and improvements to the CTPT. Undertaken day-day supervision of junior staff and trainees in the management of IMPs and setting-up new clinical trials and can plan their workload as required. Support the training of medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials.

Maintain accurate & contemporaneous records, with version control of documents and filing in accordance with SOPs. Be responsible for preparing accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment. Be competent to: o Order, receipt, undertake stock acknowledgement, pack-down, label, undertake returns and destruction of clinical trial IMPs and other medicines. o Accurately maintain, close down and archive Clinical Trial pharmacy files to ensure compliance with regulatory requirements.
- Undertake expiry date and stock level checks are carried out and that stock levels are maintained. o Temperature monitor clinical trial stocks and manage an excursion. Assist with the preparation for monitoring meetings, audits and inspections and to represent the Clinical Trials Team to update the dispensary staff at meetings. Using knowledge and skills developed to propose changes and comment on changes to SOPs.

Develop knowledge and skills for the safe use of equipment in the department: Waysafe cabinet and take responsibility for its safe use by others. Safely handle hazardous materials: chemotherapy, genetically modified investigational medicinal products, other Advanced Therapy Medicinal Products (ATMPs), dry ice etc according to departmental and Trust SOPs. Clinical Trial Aseptic Unit (CTASU) (if required) 1. To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic and non-aseptic dispensing to undertake the safe and accurate completion of product worksheets and labels, assembly of components for dose preparation, preparation of a wide range of aseptic products.2.

Use high levels of precision and accuracy to manipulate components in a gloved isolator to prepare doses accurately and safely for patients.3. To participate in the clean room/isolator cleaning rota.4. To assist in environmental and physical monitoring of the CTASU.5. To be involved in the maintenance and accurate recording of departmental records and results including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.

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