Faculty of Medicine and Health
Faculty of Medicine and Health Research Office
Quality Assurance (QA) Portfolio Monitor
Fixed term to 30 April 2018
The University of Leeds is a leader in the field of clinical trials and has an associated research portfolio.
We are looking for an enthusiastic individual to lead the internal monitoring / auditing aspect of the LTHT and University of Leeds portfolio of clinical trials and their associated quality assurance systems according to legislation and good clinical practice.
The post will be based at the Quality Assurance Clinical Trials Office, within the Research & Innovation Offices of Leeds Teaching Hospitals NHS Trust, providing a designated quality assurance function working across the University’s Faculty of Medicine and Health’s Research Office and Leeds Teaching Hospitals NHS Trust’s Department of Research and Innovation.
You will have experience of working in a quality-assured clinical research environment, including experience of Phase II / III trials, a degree in life science or a health-related subject is desirable.
You should also have a current working knowledge of applicable legal and ethical frameworks, in particular the Research Governance Framework for Health and Social Care, and Good Clinical Practice (GCP) issues relevant to the conduct and management of clinical research in the NHS.
Attention to detail, organisational, interpersonal and communication skills (including written and presentational skills) plus an understanding of key issues pertaining to clinical research are essential.
The University of Leeds is committed to providing equal opportunities for all. The university is a charter member of Athena SWAN and holds the Bronze award. We will be happy to consider job share applications and are committed to flexible working for all our employees.
University Grade 6 (£26,052 - £31,076 p.a.) depending on qualifications and experience
Informal enquiries regarding the post should be directed to Louise Brook, QA Manager tel: +44 (0)113 392 0150, email: .
If you have any specific enquiries about your online application please contact Joe Logan, tel: +44 (0)113 343 0481, e-mail: .
Interviews are expected to be held on 14 November 2016.
Job Ref: MHFAC1037 Closing Date: 3 November 2016
Background
This post is joint funded by the University of Leeds and the Leeds Teaching Hospital Trust to lead on the monitoring and audit aspects of compliance to The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004 No. 1031) including related amendments and the Commission Directive 2005/28/EC on Good Clinical Practice Directive, related to clinical trials across the two organisations.
The University of Leeds and Leeds Teaching Hospitals NHS Trust have established an integrated research management function for clinical research. For the purpose of research approval, a joint University/Trust research office has been established to approve clinical research conducted and/or led by medical and healthcare staff employed by the University of Leeds and the Leeds Teaching Hospitals NHS Trust. A key function of the joint University/Trust research office is the assessment of compliance of clinical research with the Research Governance Framework, the Medicines for Human Use (Clinical Trials) Regulations 2004 for new clinical trials and ongoing studies in Leeds.
The post holder will be based at the LTHT R & I office providing a designated quality assurance function across both organisations through the University’s Faculty of Medicine and Health’s Research Office, the NHS Trust’s Department of Research and Development liaising with the Clinical Trials Research Unit.
Purpose of the Post
To support the internal monitoring and auditing of clinical research within the University of Leeds and the Leeds Teaching Hospital NHS Trust reporting upon compliance. The Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU Clinical Trials Directive (2001/20/EC). The post will be split between internal monitoring of QA Sponsor files (approx. 60-80%) and on site monitoring within LTHT / Uol (20-40%).
Main Duties and Responsibilities
· Provide advice on issues associated with and requirements for The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006 No. 1928) and the Commission Directive 2005/28/EC on Good Clinical Practice to the Director of R&I, and Faculty Head of Research and Innovation Support (FMH) for the University of Leeds (UoL).
· Assist in developing an ongoing internal Good Clinical Practice monitoring programme of Clinical Trials Involving Medicinal Products (CTIMPs) in the UoL or LTHT, with particular focus on the management and monitoring of Sponsor oversight files.
· Provide advice to individual researchers on issues relating to protocol development, sponsorship acceptance, regulatory and GCP compliance and trial management of CTIMPs being sponsored by the UOL / LTHT; including assisting in the development and dissemination of training materials e.g. delivering GCP related training via local and national network study days.
· Work with academic staff, business managers, senior management teams and local clinical trial coordinators to improve the delivery of clinical research activity, including reviewing and advising on standard operating procedures (SOP) to ensure they meet the legislative framework and providing written and verbal post audit feedback to highlight areas of strength and weakness, sharing best practice across both organisations.
· Assist in updating of the database for recording of information relating to CTIMPs and of the QA monitoring processes.
· Independently audit historical Sponsor files to ensure documentation is maintained to an “inspection ready standard” at all times, investigating issues of non-compliance and initiating triggered monitoring visits (where applicable) in order to demonstrate a full auditable trail of trial documentation.
· Liaise with research teams to obtain missing correspondence and documentation, working with the QA Portfolio Coordinator to ensure required timelines for reporting e.g. DSURs and end of trial notification deadlines are met.
· Assist in the performance of Good Clinical Practice monitoring visits and audits and writing of audit reports.
· Advise the QA manager and the relevant senior management teams across the Faculty and the LTHT on the set up and monitoring of clinical research across the two organisations. They would be expected to act as an expert in the field making independent decisions and recognising areas of risk within a trial both at set up and monitoring.
· Maintain an up-to-date understanding and working knowledge of MRC GCP guidelines, ICH GCP guidelines, Research Governance Framework, Data Protection Act (1998) and the Medicines for Human Use (Clinical Trials) Regulations 2004
· Maintain an up-to-date understanding of changing legislation associated with GCP and quality assurance in clinical research.
· Act as a resource to external collaborators on GCP guidelines, Research Governance, Data Protection Act (1998) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
· Deliver an internal monitoring service to the Faculty of Medicine and LTHT, setting up the monitoring timetable based on their own risk assessment and be responsible for ensuring the monitoring service is 'fit for purpose' measured against internal and external standards (e.g. MHRA - Medicines and Healthcare products Regulatory Agency)
· The job description provides a framework for the role of Portfolio Coordinator in the QA office and should not be regarded as a definitive list of duties and responsibilities, which will develop and change over time through natural progression.
Relationships
The post-holder will be responsible to the Quality Assurance Manager and accountable to the Faculty Head of Research Support. They will work closely with members of the Leeds Cluster, the Faculty of Medicine and Health Research office, central Research Support and Trust R&I staff.
University Values
All staff are expected to operate in line with the university’s values and standards, which work as an integral part of our strategy and set out the principles of how we work together. More information about the university’s strategy and values is available at http://www.leeds.ac.uk/comms/strategy/
Person Specification
Essential
· Educated to degree level in a scientific subject (or equivalent qualification / experience) or experience of working in a quality assured clinical research environment
· Experience of Research Governance
· Understanding of key implications of Medicines for Human Use (Clinical Trials) Regulations 2004 on Clinical Trials
· Current working knowledge of Data Protection Act (1998), GCP, Research Governance and ethical frameworks
· Effective team working skills
· Evidence of effective negotiation and facilitation skills
· Effective interpersonal and communication skills (including written and presentational)
· Evidence of effective organisational skills
· Attention to detail
· Experience in report writing
· Ability to demonstrate initiative and flexibility
· Understanding of key issues pertaining to clinical research
Desirable
· Experience of dealing with academics and health-care professionals at all levels
· Experience in audit
· A degree in a life science or health-related subject
Faculty Information
With more than 6,000 students, 1,600 staff and annual research income of £50m, the Faculty of Medicine and Health at Leeds is bigger than some universities. Leeds has one of the largest medical and bioscience research bases in the UK, and is an acknowledged world leader in cancer, cardiovascular, psychiatric, genetic, musculo-skeletal and health services research. Treatments developed in Leeds are transforming the lives of people around the world living with conditions such as HIV, TB, diabetes and malaria.
Terms and Conditions
Details of the terms and conditions of employment for all staff at the university, including information on pensions and benefits, are available on the Human Resources web pages accessible via the links on the right hand side, or at http://hr.leeds.ac.uk/policies
Disclosure and Barring Service checks
A Disclosure and Barring Service (DBS) Check is not required for this position. However, applicants who have unspent convictions must indicate this in the ‘other personal details’ section of the application form and send details to the Recruitment Officer
Disabled Applicants
The post is located in the Quality Assurance Clinical Trials Office, within the Research and development Offices of the Leeds Teaching Hospitals NHS Trust. Disabled applicants wishing to review access to the building are invited to contact the department direct. Additional information may be sought from the Recruitment Officer, email or tel + 44 (0)113 343 1723.
Disabled applicants are not obliged to inform employers of their disability but will still be covered by the Equality Act once their disability becomes known.
Further information for applicants with disabilities, impairments or health conditions is available in the applicant guidance.