Job summary
The post-holder will work as part of the Quality Assurance (QA) Team across all sites within UHB as required but will be based at the R&D department in MIDRU at Birmingham Heartlands Hospital site or ITM at QEH.
The post holder will undertake audit and monitoring activity on both UHB hosted and sponsored trials as per the department audit and monitoring plan. They will be responsible for generating reports and interpreting findings in accordance in ICH-GCP (International Conference on Harmonisation Good Clinical Practice Guidelines) and all other applicable legislation including Medicines for Human Use (Clinical Trials) Regulations 2004 and the UK Policy Framework for Health and Social Care Research.
They will contribute to training development and delivery and the maintenance and development of internal quality assurance processes.
Main duties of the job
*Generation of audit and monitoring reports for circulation and discussion with the relevant Principal/Chief Investigators and research delivery teams.
*Ability to use Microsoft Office (Word, Outlook, Excel, and PowerPoint) daily to produce documents and reports pertaining to audit and monitoring activity.
*Responsible for the management and maintenance of a variety of databases.
*Monitor current systems to ensure regulatory compliance throughout the lifecycle of UHB hosted/sponsored studies, advising and building upon QA procedures to support study initiation, implementation, close down and archive.
*Ability to plan and manage own time and workload accordingly to balance often complex, competing demands.
*Analysis, interpretation and comparison of large amounts of complex research information provided both from local and national sources, providing summaries and highlighting trends / issues as required.
About us
We are recognised as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognise that we need incredible staff to do this.
Our commitment to our staff is to create the best place for them to work, and we are dedicated to:
Investing in the health and wellbeing of our staff, including a commitment of offering flexible working where we can;Offer our staff a wide variety of training and development opportunities, to support their personal and career development objectives.
UHB is committed to ensuring that our staff are treated fairly and feel that they belong, by creating a kind and inclusive environment. This is about equity of opportunity; removing all barriers, including discrimination and ensuring each individual member of staff reach their true potential, achieve their ambitions and thrive in their work. This is more than words. We are taking action. Our commitment to an inclusive culture is embedded at all levels of the organisation where every voice is heard, driven by our diverse and active staff networks, and at Board level by the Fairness Taskforce led by our CEO. We nurture a culture which empowers staff to challenge discriminatory behaviours and to enable people to bring their 'whole self' to a kinder, more connected and bold place to work.
University Hospitals Birmingham is a Smoke-Free premises hospital.
Job description
Job responsibilities
*Please Note : For a detailed job description for this vacancy, please see attached Job Description*
Job description
Job responsibilities
*Please Note : For a detailed job description for this vacancy, please see attached Job Description*
Person Specification
Qualifications
Essential
- *Educated to Degree level, preferably in a science subject or equivalent level of experience working in clinical research
- *Advanced knowledge and expertise (to post graduate level equivalent) pertaining to processes for gaining permission to conduct research by ethics committees, regulatory authorities and R&D departments (ideally in an NHS setting)
Experience
Essential
- *Up to date knowledge of relevant regulations/policies governing the conduct of clinical research e.g. The Medicines for Human Use (Clinical Trials)
- *Experience in planning/organising workload of self and others
- *Significant experience working in a clinical research environment (NHS Trust, University or Pharma)
- *A thorough understanding of clinical research regulations and good practice guidelines A thorough understanding of clinical research regulations and good practice guidelines
- *An understanding of the NHS research and development (R&D) funding systems and the overarching NHS R&D strategy and governance framework
- *Knowledge of the inspection and regulation environment in which the Trust operates
- *Sound knowledge of the research, Clinical information and corporate Governance agendas
- *Project planning experience
Desirable
- *Experience in undertaking, and/or co-ordinating and/or managing clinical research
- *Experience of planning and undertaking audit and monitoring in a clinical research setting
- *Experience of implementing new systems within a research environment
- *Experience of delivering training
Additional Criteria
Essential
- *Ability to communicate clearly, verbally and in written English
- *Ability to use electronic resources, such as databases
- *Excellent interpersonal communication skills with the ability to convey often complex information to a diverse audience
- *Ability to confidently lead junior members of the QA team
- *Strong personal motivational skills to ensure tasks are completed
- *Strong organisational skills and the ability to manage a busy, varied workload
- *Ability to analyse, interpret and compare data
- *Ability to contribute to a team approach and proven experience of working as part of a multi-disciplinary team
- *Ability to work across all Hospital sites within UHB
- *A flexible approach to working as part of a team across multiple hospital sites
- *Demonstrates innovative way of thinking, coming forward with new ideas to advance quality assurance processes
Person Specification
Qualifications
Essential
- *Educated to Degree level, preferably in a science subject or equivalent level of experience working in clinical research
- *Advanced knowledge and expertise (to post graduate level equivalent) pertaining to processes for gaining permission to conduct research by ethics committees, regulatory authorities and R&D departments (ideally in an NHS setting)
Experience
Essential
- *Up to date knowledge of relevant regulations/policies governing the conduct of clinical research e.g. The Medicines for Human Use (Clinical Trials)
- *Experience in planning/organising workload of self and others
- *Significant experience working in a clinical research environment (NHS Trust, University or Pharma)
- *A thorough understanding of clinical research regulations and good practice guidelines A thorough understanding of clinical research regulations and good practice guidelines
- *An understanding of the NHS research and development (R&D) funding systems and the overarching NHS R&D strategy and governance framework
- *Knowledge of the inspection and regulation environment in which the Trust operates
- *Sound knowledge of the research, Clinical information and corporate Governance agendas
- *Project planning experience
Desirable
- *Experience in undertaking, and/or co-ordinating and/or managing clinical research
- *Experience of planning and undertaking audit and monitoring in a clinical research setting
- *Experience of implementing new systems within a research environment
- *Experience of delivering training
Additional Criteria
Essential
- *Ability to communicate clearly, verbally and in written English
- *Ability to use electronic resources, such as databases
- *Excellent interpersonal communication skills with the ability to convey often complex information to a diverse audience
- *Ability to confidently lead junior members of the QA team
- *Strong personal motivational skills to ensure tasks are completed
- *Strong organisational skills and the ability to manage a busy, varied workload
- *Ability to analyse, interpret and compare data
- *Ability to contribute to a team approach and proven experience of working as part of a multi-disciplinary team
- *Ability to work across all Hospital sites within UHB
- *A flexible approach to working as part of a team across multiple hospital sites
- *Demonstrates innovative way of thinking, coming forward with new ideas to advance quality assurance processes
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.
