Faculty of Medicine and Health
School of Medicine
Leeds Institute of Cancer and Pathology (LICAP)
Section of Oncology and Clinical Research
Based at St James’s University Hospital
Clinical Trials Administrator
Due to internal promotion within the University we have an exciting and challenging career
opportunity for an excellent candidate with significant experience of working in a clinical
research setting. You will be familiar with the research governance framework for health
research, be motivated and enthusiastic, able to work independently and confidently, as well
as part of a team, provide leadership and expertise to more junior colleagues and support
clinicians in the high quality, robust conduct and clinical governance of clinical trials and
research studies within the Cancer Research UK Leeds Clinical Centre. The ability to work
under pressure, to deadlines and with close attention to detail is necessary.
We are a large and well established, mixed skills based, clinical research delivery team that
works collaboratively with oncologists, scientists and other health professionals and NHS
service support departments within Leeds Teaching Hospitals NHS Trust in the delivery of
180-200 clinical trials and research projects each year.
The University of Leeds is committed to providing equal opportunities for all and offers
a range of family friendly policies (http://hr.leeds.ac.uk/homepage/4/policies). The
University is a charter member of Athena SWAN and holds the Bronze award. The
School of Medicine gained the Bronze award in 2013. We are committed to being an
inclusive medical school that values all staff, and we are happy to consider job share
applications and requests for flexible working arrangements from our employees.
University Grade 6 (£25,513 – £30,434) depending on qualifications and experience
Informal enquiries regarding the post should be directed to Debbie Beirne, email:
d.a.beirne@leeds.ac.uk
If you have any specific enquiries about your online application please contact Colette
Cornelly, email: c.l.cornelly@leeds.ac.uk or Sharon Collins, email: s.collins@leeds.ac.uk
Job Ref: MHCAP1034
Closing Date: 11 November 2015
Background
The Oncology Clinical Trials department is located on the St James University Hospital
campus (Bexley Wing) and sits within the Cancer Research UK Leeds Centre, and more
broadly within the Faculty of Medicine and Health, School of Medicine, Leeds |Institute of
Cancer and Pathology (LICAP)
The department supports clinical trials and translational research studies across a broad
spectrum of solid tumours. We participate in approximately 200 clinical trial and research
studies annually. The majority of these trials are multi-centre Phase II and Phase III
studies; however we have a growing portfolio of academic, translational research studies
arising from LICAP, with close working relationships, alongside key industry and charity
partnerships from which experimental medicine studies evolve
We are also a UK centre for translational research through a variety of designations
including the Experimental Cancer Medicine Centre (ECMC) network (CRUK/DOH) and
the National Institute for Health Research (NIHR) Leeds Clinical Research Facility . We
have a regional partnership with Yorkshire Cancer Research (YCR).
The primary focus for this post therefore is to support and underpin the administrative
delivery of this early, translational research work arising from academic outputs and
industry collaborations, communicating effectively and driving efficient processes to meet
our stated goals. The department is committed to developing and facilitating locally derived
research, which involves recruiting patients from the regional cancer units into predominantly
Phase I and Phase II trials co-ordinated from the cancer centre and delivered through a
specific early phase clinical research clinic.
The post holder will liaise closely with the University's Clinical Trials and Research Unit
(Leeds CTRU). Other working relationships will include the national Clinical Research
Network (CRN) and the joint Research and Innovation office of Leeds Teaching |Hospitals
NHS Trust and the University of Leeds.
Purpose of Post
To provide efficient clinical trial administration and supportive management for predominantly,
but not exclusively, experimental medicine trials conducted by the oncology clinical trials
department.
Main Duties and Responsibilities
Research delivery and governance:
1. Proactively engage and liaise with research staff, including senior consultant
colleagues engaged in research, research nurses and administrative personnel
locally and in other units within the UK participating in clinical trials as relevant, in
support of the administration of research studies undertaken in this centre.
2. Provide robust clinical trial co-ordination and Principal Investigator (PI) support for
a small number of multi-centre academic studies for which Leeds is the Lead
centre.
3. Ensure that all trial functions are undertaken in accordance with national regulatory
frameworks and legislation.
4. Maintain own knowledge of current guidance and legislation underpinning clinical
research delivery, understanding all the systems and processes necessary for
attaining regulatory approval in the UK.
5. Act as a knowledgeable resource to staff locally and at other centres in the UK
where appropriate in the course of collaborative partnership working.
6. Participate in relevant internal audit projects within the cancer centre, and present
findings at designated meetings as appropriate.
7. Support the preparation process for external audit or inspections and facilitate
these visits in a professional manner in conjunction with senior colleagues.
Participate in the review of these audits and any remedial actions required.
8. Take responsibility for timely reporting of Serious Adverse Events (SAE) and
Suspected Unexpected Serious Adverse Reactions (SUSARS) to the appropriate
regulatory authorities and trial participants, in liaison with the Principal Investigator
and the Senior Clinical Trial Administrator for early phase studies.
9. Participate in departmental meetings, recording accurate minutes if so assigned
and circulating to relevant members of staff.
10. Plan the administrative management of the specific research projects under your
remit including the establishment and maintenance of office systems. Compile and
maintain a master set of source documents (Master Site File for each specific
project.
11. Respond promptly to telephone and email queries from trials centres, patients,
clinicians and health professionals regarding specific trials.
12. Work with the PI and research nurses to ensure accurate feasibility information is
derived for potential collaborative partners, based on sound data and prior trial
performance to maximise deliverability and financial stability.
13. Liaise with research staff to monitor trial recruitment and quality of activity Work
with the Principal Investigator for each trial to ensure he/she is informed and aware
of the status and any issues arising in the conduct of the trial.
14. Work with department lead and the quality assurance manager to initiate,
develop and implement Standard Operating Procedures (SOPs) where
appropriate to the remit of this post to ensure we are robust and consistent in
our delivery of research processes and compliance.
15. Maintain departmental document management systems and processes, escalating
any concerns or suggestions for service improvement as appropriate to senior
colleagues.
16. General administrative duties arising from the clinical trials activity of the unit, as
appropriate to this post and delegated by senior manager.
Staff support and management:
1.
Take a lead as designated by senior manager to supervise, train and develop trial
administrative staff under your supervision, in line with departmentally agreed training
and competency assessment procedures.
2.
Support the senior management team in the day-to-day assessment of administrative
team workload and effective deployment of resources to maximize efficiency and quality
of outputs.
3. Ensure effective team working and act as a role model for more junior staff, presenting a
professional and collegiate approach and encouraging an open, honest and fair
management style to all staff in accordance with all University of Leeds policies and
procedures.
Relationships
The post holder will be responsible on a day-to-day basis to the Oncology Business
Development Manager and Nurse Consultant, through whom they will be accountable to the
CRUK Centre Director (Prof Alan Melcher) Director of the Leeds Institute of Cancer and
Pathology (Prof Tim Bishop) and also to the Dean of the Faculty of Medicine and Health.
Person Specification
Essential
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Educated to degree level or equivalent, or be able to demonstrate relevant
experience in a research or similar setting commensurate with
requirements for this post.
Relevant experience of Clinical Trials co-ordination and delivery
General administrative experience, preferably in a healthcare environment
Ability to work as a team in a busy, sometimes pressured working environment
Working knowledge of and experience in the effective use of Microsoft
Office software and database packages.
Effective communication and interpersonal skills
Effective organisational and prioritising skills
Ability to work autonomously
Proactive, attention to detail, flexible approach
Motivated, friendly personality
Flexibility to work across different sites if required
Commitment to own personal development
Familiarity with working to national regulatory frameworks and legislation
governing research conduct
Experience of REC and R&I procedures for gaining ethical study approval
Ability to arrange and participate in simple and complex meetings including
organisation of diaries, venue and refreshments
Ability to assume a significant and substantial amount of responsibility, meet internal
and external deadlines and to work under pressure and within defined timeframes
Willingness to be trained in the use of Trust and University administrative and study
finance costing systems as appropriate
Desirable
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Clinical research qualification
Familiarity with project management
Knowledge of data protection issues and legislation in the NHS
Experience of designing data collection forms
Effective presentation skills using IT packages
The Leeds Institute of Cancer and Pathology (LICAP)
Director: Professor Tim Bishop
http://medhealth.leeds.ac.uk/info/900/leeds_institute_of_cancer_and_pathology
The Leeds Institute of Cancer and Pathology addresses both laboratory based and clinical
research into cancer with a major focus on translational science. LICAP is one of the largest
cancer Institute’s in the country and has major financial support from the cancer charities. The
laboratories and clinical research are all based on the St James’s site with laboratory activities
being located in the Wellcome Trust Brenner Building and adjacent buildings while the clinical
work is based within Bexley Wing. The Institute consists of seven Sections: Epidemiology &
Biostatistics; Experimental Haematology; Experimental Oncology; Oncology & Clinical
Research (Clinical); Oncology & Clinical Research (Laboratory); Patient Centred Outcome
Research; and Pathology & Tumour Biology.
Cancer Research UK Leeds Centre
http://www.cancerresearchukcentre.leeds.ac.uk
The Leeds Cancer Research UK Centre is a partnership between the University of Leeds,
Leeds Teaching Hospitals NHS Trust and Cancer Research UK, which aims to harness the
scientific power of Leeds-based cancer researchers to deliver improvements in cancer care at
local, national and international level. It fosters excellence in basic and translational research
and offers services to all cancer researchers in Leeds, irrespective of their funding source.
Beyond research, the Centre is also keen to build stronger relationships with the local
community, with patients undergoing cancer treatment, their carers, cancer survivors and the
wider public.
Faculty Information
Faculty of Medicine and Health Information
With more than 6,000 students, 1,600 staff and annual research income of £60m, 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.
The School of Medicine
The School of Medicine at the University of Leeds is a major international centre for research
and education. Our ambition is to improve health and reduce health inequalities, locally and
globally, through excellent scientific research and the translation of that research into
healthcare practice, and through the education of future scientific and clinical leaders who will
advocate and practise an evidence-based approach. Our major strategic aims are to:
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Deliver outstanding research including basic discovery science through to applied
health research that makes a significant difference to health.
Produce exceptional graduates, clinicians, educators, doctoral and post-doctoral
fellows whose learning has been informed and inspired by our research excellence
and who will form the next generation of academic and clinical leaders.
Develop and support knowledge transfer activities that flow from our academic
activities.
Create and maintain an efficient and sustainable environment for research and
teaching within an organisational culture and management style that enacts and
supports the university’s core values of community, inclusiveness, integrity and
professionalism.
The School of Medicine is organised into seven Institutes. All are committed to high quality
research-led teaching, through their training of postgraduate research students, delivery of
postgraduate taught courses, and its leadership in undergraduate teaching. The School works
closely with the local NHS, having a number of jointly funded clinical posts to ensure this
relationship is effective and strong for both research and student education.
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 Leeds Institute of Oncology, 6th Floor, Bexley Wing, St James’s
University Hospital, Beckett Street, Leeds LS9 7TF. 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 disclosure@leeds.ac.uk 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.