This role is a band 4 to 5 progression post and once the criteria outlined in the various sections under band 5 are met, the post holder will move from band 4 to 5.
The post holder will work within the CRF QA Manager and CRF team and be responsible for the management and maintenance of samples processed within the clinical research facility, the maintenance of the Ultra-Low Temperature Freezers, and other storage systems. You will also be responsible for writing robust Standard Operating Procedures related to this area of practice.
You will work closely with the local Research and Innovation office and the King's Health Partners Clinical Trials office to ensure that samples for Clinical Trials, both commercial and non-commercial are managed and maintained within the framework of current ICHGCP guidance, MHRA and HTA legislation and Research Governance
* Be responsible for the management of samples received and stored at the CRF
* Be responsible for the maintenance of the storage facilities and ensure that temperatures are maintained within set limits.
* Respond to alarms when necessary during working hours to ensure storage facilities are maintained within set limits
* To be able to follow departmental SOPs and prepare samples accurately
* To be able to use computer systems correctly, enter data accurately from transcription sheets or request forms
* To assist in the training and supervision of staff working in the CRF as part of their induction.
The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
* Be responsible for the management of samples received and stored at the CRF
* Be responsible for the maintenance of the storage facilities and ensure that temperatures are maintained within set limits.
* Respond to alarms when necessary during working hours to ensure storage facilities are maintained within set limits
* To be able to follow departmental SOPs and prepare samples accurately
* To be able to use computer systems correctly, enter data accurately from transcription sheets or request forms
* To assist in the training and supervision of staff working in the CRF as part of their induction.
* To support the Quality Assurance Manager in the development of the CRF tracked Sample Storage Facility
* To attend and contribute to any meetings and SIV's in relation to Clinical Trials and sample management and to feedback and recommend any changes and/or improvements to the service as appropriate to the CRF Team Leader or Principal Investigator
* To be responsible for the implementation of SOP's and procedures specific to Clinical Trial Protocols that will have an impact within the CRF department
* To contribute to wider policies that have an impact within the CRF and across the Trust
* To assist in the regular review and update of SOP's and procedures as agreed with the QA Manager.
* To propose changes to working practices and Sample preparation techniques that will maximise the potential for efficiency and safety
* To be knowledgeable on the current framework of ICHGCP guidance, MHRA and HTA legislation and Research Governance.
* To ensure that both commercial and non-commercial are managed and maintained within the framework of current ICHGCP guidance, MHRA and HTA legislation and Research Governance.
* Actively participate in the development and management of PBMC preparation service