Job summary
This post is part of the Clinical Research Division (CRD) Quality Assurance (QA) team. The post holder will conduct auditing and monitoring of CRD studies, support the Research Nurses, Research Governance manager and and Research Facilitators in implementing any corrective actions, collate QA metrics and support the maintenance of the CRD & CRF dashboard. Manage the CRD/CRF SOPS via the iPassport system . Support training of CRD staff. The post holder will have the ability to comply with ICH GCP guidelines for clinical research as well as Alder Hey guidelines and policies.
The post holder will be familiar with Clinical Research and auditing processes and be willing to undergo further training as required
Main duties of the job
Education to a minimum of 5 GCSE standard or equivalent
Previous data collection or clinical audit experience
Experience of working with MS Office (Word, Excel, Access, Outlook, PowerPoint etc.)
Practical experience of email, internet and data input.
Experience of having worked within and/or supported work in a regulated environment such as research
Good working knowledge of quality assurance process
Good working knowledge of the use of information systems to manage data confidentially in the NHS.
Organised
Excellent verbal and written communication skills.
Good time management.
Attention to detail
Ability to communicate effectively on many levels.
Able to use keyboard and accurately prepare paperwork.
Able to work in a team .
Able to motivate oneself and work independently, but seek advice when necessary.
About us
As one of Europe's biggest and busiest children's hospitals, at Alder Hey Children's NHS Foundation Trust, we treat everything from common illnesses to highly complex and specialist conditions.In addition to our main hospital site, we offer paediatric services at a number of community sites and hold local clinics across Merseyside, Cumbria, Shropshire, Wales and the Isle of Man. We also provide specialist inpatient care for children with complex mental health needs in our recently relocated and newly opened state of the art facility.
Alder Hey has a thriving research portfolio and leads research into children's medicines, infection, inflammation and oncology. We are becoming recognised as one of the world's leaders in children's healthcare and research. We contribute to public health, lead cutting-edge research and teach the next generation of children's specialists. Alongside this is ourInnovation Hub, a dedicated space where clinicians and industries can come together to create new products and technologies.
We know that a children's hospital is different and that our job is more than just treating an illness. To us, every child is an individual. As well as giving them the very best care, we set out to make them feel happy, safe and confident as they play, learn and grow. At Alder Hey we are here to look after a child and their family and that includes mums, dads, brothers and sisters.
Job description
Job responsibilities
. To undertake audits in line with the CRD rolling audit program.
To undertake monitoring of studies and trial documentation. To liaise with CRD research delivery staff and the wider trust, e.g. laboratory managers & Consultants, to ensure appropriate QA processes are implemented and adhered to.
2. To liaise with Research Governance Manager to review critical and major findings resulting from internal/external inspections and to produce and implement CAPA reports
3. To assist with the review and closure of CAPA reports
4. To provide oral and written reports on activities to the Research Governance manager in line with overall responsibilities.
5. To undertake relevant training. To perform any other duties required by Research Governance Manager
Communication and Relationships
Analytical and Judgemental skills
Planning and Organisational skills
Please see JD attached for full Job Description
Physical Dexterity
Keyboard skills
Physical requirement for prolonged periods of concentration when cross referencing information and data
Frequent need to carry cumbersome trial files from clinical areas and within the offices
Policy and Service Development
Requirement to keep up to date with policy developments pertaining to QA and support implementation where necessary e.g. ICH GCP
To provide information regarding the performance of the CRF/CRD vs QA metrics across the portfolio
Education and Training
To act as a QA resource for CRD/CRF staff and others involved in research studies within the trust
To maintain an awareness of current advances in QA clinical research
To continue professional development and attend training and meetings as required. Attend regular updates and feedback to multi-disciplinary team on developments in regulatory guidelines pertaining to QA for clinical research
Attend annual UKCRF conference if required
Research and Development
As a member of the multi-disciplinary team there will be involvement in the entire process of supporting clinical trials and other research studies.
Other
To understand and adhere to local Trust policies and procedures
The post holder has responsibility for safety as outlined in the hospitals policy and Health and Safety Work Act 1974
To maintain confidentiality at all times
Job description
Job responsibilities
. To undertake audits in line with the CRD rolling audit program.
To undertake monitoring of studies and trial documentation. To liaise with CRD research delivery staff and the wider trust, e.g. laboratory managers & Consultants, to ensure appropriate QA processes are implemented and adhered to.
2. To liaise with Research Governance Manager to review critical and major findings resulting from internal/external inspections and to produce and implement CAPA reports
3. To assist with the review and closure of CAPA reports
4. To provide oral and written reports on activities to the Research Governance manager in line with overall responsibilities.
5. To undertake relevant training. To perform any other duties required by Research Governance Manager
Communication and Relationships
Analytical and Judgemental skills
Planning and Organisational skills
Please see JD attached for full Job Description
Physical Dexterity
Keyboard skills
Physical requirement for prolonged periods of concentration when cross referencing information and data
Frequent need to carry cumbersome trial files from clinical areas and within the offices
Policy and Service Development
Requirement to keep up to date with policy developments pertaining to QA and support implementation where necessary e.g. ICH GCP
To provide information regarding the performance of the CRF/CRD vs QA metrics across the portfolio
Education and Training
To act as a QA resource for CRD/CRF staff and others involved in research studies within the trust
To maintain an awareness of current advances in QA clinical research
To continue professional development and attend training and meetings as required. Attend regular updates and feedback to multi-disciplinary team on developments in regulatory guidelines pertaining to QA for clinical research
Attend annual UKCRF conference if required
Research and Development
As a member of the multi-disciplinary team there will be involvement in the entire process of supporting clinical trials and other research studies.
Other
To understand and adhere to local Trust policies and procedures
The post holder has responsibility for safety as outlined in the hospitals policy and Health and Safety Work Act 1974
To maintain confidentiality at all times
Person Specification
essential
Essential
- minimum 5 GCSEs standard or equivalent
- Previous data collection or audit experience
Desirable
- GCP
- Previous quality assurance experience
- Previous clinical research experience
Person Specification
essential
Essential
- minimum 5 GCSEs standard or equivalent
- Previous data collection or audit experience
Desirable
- GCP
- Previous quality assurance experience
- Previous clinical research experience
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).
Employer details
Employer name
Alder Hey Children's NHS Foundation Trust
Address
Alder Hey Childrens Hospital NHS FT
IITP Eaton Road, Liverpool,
Liverpool
L12 2AP
Employer's website
https://alderhey.nhs.uk/ (Opens in a new tab)
