Job summary
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
Main duties of the job
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.
About us
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.
Job description
Job responsibilities
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 SIVs 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 SOPs 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 SOPs 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
Job description
Job responsibilities
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 SIVs 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 SOPs 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 SOPs 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
Person Specification
Education and Qualifications
Essential
- NVQ Level 3 plus accredited underpinning knowledge (BTEC in Pharmaceutical Science or equivalent) or equivalent.
- Mandatory CPD to maintain fitness to practice.
Desirable
- HND or BSc degree in relevant subject area (covering basic molecular and cell biology), or equivalent vocational qualification and equivalent experience in QC laboratory management
- Current certified ICH-GCP training
- Accredited Checking Technician qualification or working towards.
Knowledge and Experience
Essential
- Knowledge of all regulations and legislation relevant to Clinical Trials.
- Experience of working in and day to day management of GLP Quality Control Laboratories
Skills and Competencies
Essential
- Ability to plan own workload
- Able to maintain the working environment to a high standard of cleanliness and tidiness
- Excellent record keeping, attention to detail
- Organisational skills - able to deliver agreed objectives within an agreed timeframe
- Communication skills - able to relate and communicate with all levels and with different professions, able to work with others and to follow instructions
- Good understanding of basic mathematics
- Ability to communicate effectively using clear written and spoken English
- Be able to make sound judgments on how to fulfil urgent orders, where there is a range of options.
- Be able to prioritise tasks on a day to day basis
- To be able to analyse a range of facts or situations and be able to compare a range of options.
- Be able to plan and organise straightforward activities, some ongoing.
- Work on their own and as a team
- To possess highly developed physical skills in relation to accuracy.
- To have basic keyboard and computer skills
- Be able to participate in frequent light physical effort for several short periods
- To be able to move laboratory goods
- Be able to concentrate for extended periods despite an unpredictable work pattern
- Self motivated - works to a high standard, sets themselves and helps others to set attainable goals; wants to improve, to be more effective and efficient; measure progress against target
- Be methodical in all laboratory work.
- Resilient and resourceful - able to cope under pressure
- Be flexible in responding to demands of the service
Person Specification
Education and Qualifications
Essential
- NVQ Level 3 plus accredited underpinning knowledge (BTEC in Pharmaceutical Science or equivalent) or equivalent.
- Mandatory CPD to maintain fitness to practice.
Desirable
- HND or BSc degree in relevant subject area (covering basic molecular and cell biology), or equivalent vocational qualification and equivalent experience in QC laboratory management
- Current certified ICH-GCP training
- Accredited Checking Technician qualification or working towards.
Knowledge and Experience
Essential
- Knowledge of all regulations and legislation relevant to Clinical Trials.
- Experience of working in and day to day management of GLP Quality Control Laboratories
Skills and Competencies
Essential
- Ability to plan own workload
- Able to maintain the working environment to a high standard of cleanliness and tidiness
- Excellent record keeping, attention to detail
- Organisational skills - able to deliver agreed objectives within an agreed timeframe
- Communication skills - able to relate and communicate with all levels and with different professions, able to work with others and to follow instructions
- Good understanding of basic mathematics
- Ability to communicate effectively using clear written and spoken English
- Be able to make sound judgments on how to fulfil urgent orders, where there is a range of options.
- Be able to prioritise tasks on a day to day basis
- To be able to analyse a range of facts or situations and be able to compare a range of options.
- Be able to plan and organise straightforward activities, some ongoing.
- Work on their own and as a team
- To possess highly developed physical skills in relation to accuracy.
- To have basic keyboard and computer skills
- Be able to participate in frequent light physical effort for several short periods
- To be able to move laboratory goods
- Be able to concentrate for extended periods despite an unpredictable work pattern
- Self motivated - works to a high standard, sets themselves and helps others to set attainable goals; wants to improve, to be more effective and efficient; measure progress against target
- Be methodical in all laboratory work.
- Resilient and resourceful - able to cope under pressure
- Be flexible in responding to demands of the service
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
