Job Description and Person SpecificationLast updated: 1st June 2016

JOB DESCRIPTION

Post title: Research Programme Manager

Academic Unit/Service: Primary Care and Population Sciences (PCPS)

Faculty: Medicine

Career Pathway: Management, Specialist and Administrative (MSA)

Level: 5

*ERE category: n/a

Posts responsible to: Chief investigator leading research programme

Posts responsible for: Research assistants and administrative staff employed on research programme

Post base: Office-based but involving lone working at times (see job hazard analysis)

Job purpose

This post is funded through a National Institute for Health Research (NIHR) Programme Grant for Applied Research (PGfAR) led by the Chief Investigator Professor Tony Kendrick, entitled REviewing long term anti-Depressant Use by Careful monitoring in Everyday practice (the REDUCE programme). It is offered for one year in the first instance, with the aim of extending it to six years subject to satisfactory progress. It is a collaborative programme between the Universities of Southampton, Liverpool, York, Hull, and University College London, and staff at the Solent NHS Trust involved in the administration, monitoring, and hosting of the grant.The purpose of the post is to manage or co-manage the research and administrative staff employed on the programme; coordinate ethics and research governance applications; organise the recruitment and follow-up of participants and manage the recording of collected data; develop standard operating procedures and systems for managing the research; oversee the management of the grant budget;, and to be accountable for ensuring that the research programme is conducted to the highest possible standards, and meets the necessary deadlines.

Key accountabilities/primary responsibilities % Time

1. Manage the day-to-day running of the research programme in accordance with study protocols. Be accountable for ensuring the successful conduct of the research programme to the highest possible standards, and its completion on time and within the grant budget.

30 %

2. Directly supervise, or co-supervise with grant co-applicants as appropriate, the work of the research and administrative staff employed on the programme in Southampton, other Universities, and collaborating organisations.

25%

Key accountabilities/primary responsibilities % Time

3. Establish a working division of responsibilities with the staff employed on the grant and the academics and collaborating institutions contributing to the programme.

5 %

4. Co-ordinate and draft applications to the research sponsor, research ethics committees, R&D departments, and the HRA, when required. This will involve drafting/amending forms, participant invitation letters, information sheets, questionnaires, protocols and other documentation.

5 %

5. Manage monitoring procedures and make appropriate interventions to meet both internal and external requirements, including NHS ethics and research governance requirements for the conduct of the research.

5 %

6. Liaise with other key staff, including University and NHS human resources, finance, and IT staff, and colleagues in the collaborating Clinical Trials Unit, and Health Psychology group.

5 %

7. Co-ordinate the various aspects of the work of the research and administrative staff and ensure appropriate training of these staff, motivating them and dealing with any staff issues which arise.

5 %

8. Advise on recruiting participants and actively supervise the gathering of data and literature for the programme. Take responsibility for escalating trial specific issues to the sponsor and ethics committee when required, working with the chief investigator.

5 %

9. Attend the steering group meetings and, with the administrative staff, compile and follow-up action points.

5 %

10. Co-ordinate the preparation and publication of data, reports, performance metrics and information. Advise on writing the final report on the research programme, on preparing papers for publication, and on submitting posters and oral presentations for conferences.

5 %

11. Any other duties as allocated by the line manager following consultation with the post holder.

5 %

Internal and external relationships

Other members of the programme research team in Southampton, in PCPS, Health Psychology, and the CTU.Co-applicants from the Universities of York, Hull, Liverpool and UCL – Simon Gilbody, Una Macleod, Chris Dowrick, Glyn Lewis and Joanna Moncrieff, and staff in those universities employed on the grant. Patient and Public Involvement representatives, throughout the lifecycle of the programme.NHS Solent – liaise with Medical Director Dan Meron, R&D lead Sarah Williams and Finance Officer Julia Nobes. Clinical research networks and participating general practices relating to all collaborating centres.Members of the Programme Steering and Data Management and Ethics Committees, ensuring that travel arrangements and costs for committee members are appropriately managed. PCPS Academic Unit, Faculty of Medicine, and University HR, finance, and administrative staff.

Special Requirements

Requirement to travel to participating centres, meetings, and conferences throughout the UK and occasionally internationally.Flexible working hours on occasion, when necessary to meet deadlines.

REDUCE Programme Manager

PERSON SPECIFICATION

Criteria Essential Desirable How to be assessed

Qualifications, knowledge and experience

A good first degree in a relevant subject area, or equivalent experience.Skill level equivalent to achievement of a professional qualification or postgraduate degree.Experience of working on a multicentre clinical trial in a UK primary care setting.Proven experience of managing a large research project and its budget.Competence with Microsoft Word, Excel, PowerPoint, and databases for managing research activity.Awareness of ethical and legal requirements for medical research.

A higher research degree (MSc/MRes/PhD).

Experience of managing a multi-centre clinical trial in a UK primary care setting.

Knowledge and experience of the NIHR, UKCRN, primary care organisations, and non-commercial trial funders.

Trained in Good Clinical Practice for research.

Application/interview

Planning and organising

Able to plan and manage a major research programme.Able to develop, implement and monitor standard operating procedures.

Application/interview

Problem solving and initiative

Able to apply originality in modifying existing approaches to solve problems and meet deadlines.

Interview

Management and teamwork

Proven people management skills.Able to manage team dynamics, ensuring any potential for conflict is managed effectively.Able to formulate development plans for research and administrative staff to meet current and future needs.

PRINCE2 or similar project management qualification.

Application/interview

Communicating and influencing

Effective verbal and written communication skills.Able to persuade and influence in order to foster and maintain relationships.Able to resolve tensions and difficulties as they arise.Proven ability to write reports and regulatory documents.

Ability to make presentations in meetings and at conferences.Record of publications in peer-reviewed journals.

Application/interview

Other skills and behaviours

Experience of using an accountancy system.

Application/interview

Special requirements

Standard Disclosure and Barring Service (DBS) clearance for working with vulnerable adults.

Application/interview

REDUCE Programme Manager

Ability to travel to research sites and meeting venues across the country.

REDUCE Programme Manager

JOB HAZARD ANALYSIS

Is this an office-based post?

☐ Yes If this post is an office-based job with routine office hazards (eg: use of VDU), no further information needs to be supplied. Do not complete the section below.

☒ No If this post is not office-based or has some hazards other than routine office (eg: more than use of VDU) please complete the analysis below.Hiring managers are asked to complete this section as accurately as possible to ensure the safety of the post-holder.

## - HR will send a full PEHQ to all applicants for this position. Please note, if full health clearance is required for a role, this will apply to all individuals, including existing members of staff.

ENVIRONMENTAL EXPOSURESOccasionally (<30% of time)

Frequently(30-60% of time)

Constantly(> 60% of time)

Outside work Extremes of temperature (eg: fridge/ furnace)## Potential for exposure to body fluids## Noise (greater than 80 dba - 8 hrs twa)## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes, biohazards). Specify below:Frequent hand washingIonising radiation EQUIPMENT/TOOLS/MACHINES USED## Food handling ## Driving university vehicles(eg: car/van/LGV/PCV) ## Use of latex gloves (prohibited unless specific clinical necessity)## Vibrating tools (eg: strimmers, hammer drill, lawnmowers) PHYSICAL ABILITIESLoad manual handlingRepetitive crouching/kneeling/stoopingRepetitive pulling/pushingRepetitive liftingStanding for prolonged periodsRepetitive climbing (ie: steps, stools, ladders, stairs)Fine motor grips (eg: pipetting)Gross motor gripsRepetitive reaching below shoulder heightRepetitive reaching at shoulder heightRepetitive reaching above shoulder heightPSYCHOSOCIAL ISSUESFace to face contact with public √Lone working √## Shift work/night work/on call duties

REDUCE Programme Manager

FURTHER PARTICULARS

REviewing long term anti-Depressant Use by Careful monitoring in Everyday practice (the REDUCE programme)

Background: Antidepressant prescriptions have risen steadily, due to GPs prescribing longer courses, and the average length of treatment is now >2yrs. Some people need long-term antidepressants to prevent relapse, but surveys suggest 30-50% have no indication for long-term use. However stopping is not easy, due to withdrawal symptoms including anxiety and mood changes which feel similar to the reason why treatment was started in the first place. Patients on long-term treatment are often given repeat prescriptions and reviewed only infrequently. When GPs are prompted to review patients and advise withdrawal where appropriate, only 7% successfully withdraw. Practitioners need guidance to provide support for withdrawal, and patients need 24hr support.Aim: To identify feasible, safe, effective, and cost-effective ways of helping patients taking long-term antidepressants withdraw from treatment when appropriate.Objectives:1. Conduct a systematic review of interventions used to help patients successfully withdraw from antidepressant treatment.2. Identify factors promoting or inhibiting treatment withdrawal, through interviews with patients, and focus groups with practitioners.3. Develop an internet-supported CBT-based intervention to support treatment withdrawal, through co-design and co-production with practitioners and patients.4. Determine the effectiveness of the intervention through a randomised controlled trial, and estimate cost-effectiveness from a health/social service perspective.5. Build a translational framework addressing how the intervention should be delivered, including overcoming practitioner and patient related barriers, to facilitate implementation.Research plan:Five work streams (WS)WS1. Systematic review of interventions facilitating antidepressant withdrawal (months 1-9).Papers will be identified through comprehensive searches (Medline/Embase/DARE/CINAHL/ PsycINFO). Selection for inclusion, based on a priori criteria, will be by two independent researchers. A thematic synthesis will be performed, and if appropriate data will be combined through meta-analysis.WS2. Intervention planning (months 1-12).This will draw on our PPI and team's expertise, informed by theoretical modelling based on identified literature, and insights gained from CBT-based internet programmes for anxiety and depression. Planning will also be informed by 15-20 qualitative patient interviews, and focus groups with 15-20 practitioners. Thematic analysis will be used, checking agreement between analysts, and discussing emerging themes with the whole team.WS3. Co-production of internet-supported withdrawal intervention (months 10-24).Internet-supported advice for patients on dealing with withdrawal symptoms and when to seek help will be delivered using LifeGuide software developed in Southampton. Clinical support will be provided by a primary care mental health worker (PCMHW) by telephone. Other interventions identified in WS1-2, e.g. buddying, may be added. The website will be iteratively developed, through qualitative interviews with 15-20 patients, and 15-20 practitioners. Once a prototype is created, qualitative research with another 15-20 patients will explore whether it is acceptable, interesting, persuasive, and feasible. Think-aloud interviews will be employed, and thematic analysis used to identify improvements, iteratively.WS4. Feasibility RCT, to assess acceptability, recruitment, and outcome measures (months 22-36).We will recruit 20 patients per arm, from 14 practices over 3 months, and follow them up for 6 months. We will assess recruitment; attrition; choice of outcome questionnaires; and adherence (automatically recorded by LifeGuide). We will explore burden of treatment, need for mental health worker telephone support, and technical support. A qualitative process evaluation will be conducted through interviewing 15-20 patients and 15-20 practitioners.WS5. Fully powered RCT to demonstrate effectiveness, and cost-effectiveness (months 37-72).Inclusion criteria: having received treatment for >1 year for a first episode or >2 years for a recurrent episode; no longer depressed; not at significant risk of relapse. Cluster randomising practices (stratifying by size, location, and deprivation) to avoid contamination between arms arising from practitioner training. Baseline measures: socio-demographics; internet experience; work status; comorbidities; symptoms (PHQ-9/GAD-7); QoL (EQ-5D-5L and SF-12); NHS/SS resource use over previous 3 months.

REDUCE Programme Manager

Patients in both arms will have treatment reviewed by their GP/NP, with appointments for follow-up. Intervention arm practitioners will be trained in supporting withdrawal, and patients helped to engage with the web-based support package.Follow-up will be by post, with telephone back-up, blind to allocation, at 3, 6, 9 and 12m. Primary outcome: depression at 6m, powered to demonstrate non-inferiority (<2 point difference on the PHQ-9 questionnaire). Sample size (90% power, one-sided alpha 2.5%, 1.036 cluster design effect, 20% non-compliance/loss to follow up): 402 patients randomised from 134 practices. Secondary outcomes: antidepressant discontinuation; quality of life; mental wellbeing; withdrawal symptoms; side-effects; satisfaction; adherence.ITT (and PP) analyses will use logistic/linear regression, controlling for baseline values, stratification variables, practice, and appropriate confounders. Patterns of missing data will be explored, with imputation if appropriate, and CACE analyses conducted. Process evaluation: quantitative assessment of effects of baseline patient characteristics and psychological factors; qualitative interviews to understand patients’ perspectives and influences on trial outcomes.Projected outputs & dissemination: Translational framework on implementing internet-supported intervention to support antidepressant withdrawal, disseminated through patient groups. Publications: systematic reviews; Markov modelling; patient numbers; intervention development; feasibility study; trial results; cost-effectiveness; implementation framework.Benefits to patients/the NHS: Reductions in inappropriate treatment of patients, costs of drugs, and monitoring.

Co-applicants: University of Southampton: Michael Moore, Geraldine Leydon, Paul Little, Carl May, Gareth Griffiths, Lily Yao, Adam Geraghty, Beth Stuart. University of Liverpool: Chris Dowrick. University of York: Simon Gilbody. University of Hull: Una Macleod. University College London: Glyn Lewis, Joanna Moncrieff. Patient and public co-applicant: Sue Collinson. Solent NHS Trust: Daniel Meron.

Supported by: Solent NHS Trust: Sarah Williams, Julia Nobes. Southampton Clinical Trials Unit: Senior Trials Manager, Statistician. Health Psychology group, University of Southampton: LifeGuide Research Fellows, Research Assistant, Software Programmer, and Dr J Joseph.

Organisational chart of responsibilities:

REDUCE Programme Manager

Chief Investigator (Prof Tony Kendrick)

Liaise with co-applicants and other colleagues listed above

Programme Manager

Co-manage research and administrative staff in Universities of Liverpool, Hull, UCL and York with co-

applicants Dowrick, Macleod, Lewis and Gilbody

Manage research and administrative staff in University of Southampton

Co-manage health economics staff in Southampton with co-applicant Yao

Liaise with Solent NHS Trust R&D and Finance

The UniversityThe University of Southampton is a leading research-intensive University, a member of the Russell Group and one of the top 100 universities worldwide. We deliver an excellent educational experience and world-leading research, and we are known for successfully commercialising that research through enterprise. This is an exciting time to join the University of Southampton. We have an aspirational University Strategy (see www.southampton.ac.uk/strategy), setting out our ambitions over the next five years. The strategy involves achieving a top 10 place in the UK for research, through investing in the highest quality staff and facilities. We are also transforming the education offered to undergraduate and postgraduate students, providing greater flexibility and modular courses, with a strong international focus.

The Faculty of MedicineThe Faculty of Medicine seeks to build upon strong foundations of basic research and clinical translation. Working with colleagues across the University and in the local NHS we have strengthened our position as a renowned centre for translational research, leading innovative learning and discovery for better health across the lifecourse. Key to the success of the Faculty of Medicine is the delivery of high-quality undergraduate and postgraduate education and research, building on our strong partnerships with University Hospital Southampton NHS Foundation Trust, Solent NHS Trust, Southern Health NHS Foundation Trust, and general practices across Wessex.

Medical EducationWe offer a range of undergraduate programmes: the BM4 programme, a graduate-entry four-year programme which accepts 40 students per year; and the BM5and BMedSc programme which accepts 200 students per year including approximately 30 students from a BM6 programme aimed at widening access to a medical career. Science teaching in the first three years of the BM programmes is delivered in the South Block of Southampton General Hospital as well as the Life Sciences Building on Highfield Campus. Clinical teaching takes place at Southampton General Hospital and the adjoining Princess Anne Hospital, the Royal South Hants Hospital, and in NHS Trusts and general practices throughout Hampshire, Dorset, West Sussex and Wiltshire. In addition to the undergraduate BM programmes the School provides two Masters Degree programmes in Public Health Nutrition and Allergy.

ResearchThe Faculty of Medicine has a clear research strategy to investigate the biomedical basis of common human diseases and to translate this into clinical practice. The Faculty’s research is delivered through four Academic Units:• Cancer Sciences• Clinical and Experimental Sciences• Human Development and Health• Primary Care and Population SciencesAll research is organised and managed by these Academic Units, each of which has clear evidence of international excellence. Each carries a significant degree of devolved responsibility for its research budgets and grants, space, equipment and personnel. Working in close partnership with University Hospital Southampton NHS Foundation Trust, translational research is delivered through the Southampton Centre for Biomedical Research, bringing together the Wellcome Trust Clinical Research Facility, the Clinical Trials Unit, NIHR Biomedical Research Centre in Nutrition & Lifestyle, NIHR Biomedical Research Unit in Respiratory Medicine, shadow Biomedical Research Units in Cardiovascular, and Bone and Joint Disease, and the Cancer Research UK, Experimental Cancer Medicine Centre.

REDUCE Programme Manager

 Primary Care and Population Sciences (PCPS) Academic UnitPCPS is an academic group of over 70 staff with an increasingly unified management and research strategy led by Michael Moore, Professor of Primary Care Research. Our constituent Groups are:-• The Primary Care Research Group• The Public Health Group• The Medical Statistics Group• The Health Economics Assessment Team (HEAT) • The Qualitative Research Methods Group• The NIHR RDS (Research Design Service) South Central

Since 2008 the Primary Care Group (research-led by Professor Paul Little) has been a member of the NIHR School for Primary Care Research (SPCR). The Unit has attracted a wide range of funding, notably from NIHR (Programme Grants, Health Services Research, EME, Public Health Research, RfPB, Health Technology Assessment) as well as other research bodies e.g. MRC, Arthritis Research Council and Macmillan Trust. Several NIHR HTA and programme grants are already underway in addition to the REDUCE programme.Primary Care and Population Sciences has a thriving group of postdoctoral staff (clinical and non-clinical) and 20 postgraduate students. There is methodological expertise in qualitative methods, statistics, epidemiology, health psychology and health economics in the Unit.

Key clinical research topics for the PMC group currently include:• treatment decisions in the management of acute self-limiting illness (including antibiotic

prescribing strategies for common infections)• asthma and COPD• mental health• kidney disease• liver disease and alcohol use• early diagnosis and survivorship in cancer• patient communication, and • the use of complementary and alternative medicines, examining specific effects and non-specific

(placebo and contextual) effects.

The group employs a range of methodologies including: • randomised controlled trials to identify clinical benefit, cost-effectiveness and predictors of

response; • cohort studies using routinely collected data (from the Clinical Practice Research Datalink and

Hampshire Health Record databases) to identify outcomes in routine practice including uncommon complications;

• case-control studies to identify high risk groups; • validation studies to assess the diagnostic value of clinical decision rules and near patient tests; • qualitative studies of patient and practitioner decision-making including organisational factors

affecting the implementation of research evidence; and • observational and questionnaire studies of help-seeking behaviour, treatment decisions, and

adherence to treatment.The group collaborates with a range of non-medical research scientists in multi-disciplinary projects. Within the University of Southampton these include Professor Paul Roderick (Public Health), Professor Peter Smith, Professor Phillip Prescott, Dr Mark Mullee and Dr Ruth Pickering (Statistics); Professor James Raftery and Dr Lily Yao (Health Economics); Professor Lucy Yardley and Dr Felicity Bishop (Health Psychology); and Professors Alison Richardson, Mandy Fader, and Maria Stokes (Health Sciences). Sixteen PhD students are currently being co-supervised by members of the Department, which also hosts four post-doctoral fellowships.

REDUCE Programme Manager

We are therefore a very diverse and vibrant Academic Unit with a broad range of research disciplines. To find out more, please visit our website:-http://www.southampton.ac.uk/medicine/academic_units/academic_units/primary_care_population.page

Further informationFor further information regarding the appointment, please contact any of the following:Professor Tony Kendrick - ark1@soton.ac.uk Professor Michael Moore – mvm198@soton.ac.uk Associate Professor Geraldine Leydon – g.m.leydon@soton.ac.uk

Professor Tony Kendrick has carried out research into mental health problems in primary care for 25 years, the results of which have influenced NICE guidelines and performance indicators in the GP contract QOF for depression and schizophrenia. He is Chair of the NIHR GP Academic In-Practice Fellowships Panel and a member of the NICE Clinical Indicators Advisory Committee (since 2009). He chaired the NICE guideline development group on identification and care pathways for common mental health disorders and is a member of the NICE depression guideline development group.Professor Michael Moore is Head of PCPS and a part-time general practitioner in Salisbury. He is active in the local Integrated Clinical Research Network, he was the RCGP National Clinical Champion for Antibiotic Stewardship 2012-15, and is a member of the government advisory board for antimicrobial stewardship (ARHAI) His research interests include minor illness with a focus on antibiotic sparing strategies, obesity and chronic liver disease, as well as depression,. Associate Professor Geraldine Leydon is a medical sociologist with qualitative research expertise and special interests in communication in the consultation, cancer care and support, as well as mental health. She is content and linguistic editor for the Qualitative Sociology Review.

REDUCE Programme Manager