Job summary
This post is intended to manage a multi-centre feasibility trial examining the use of cognitive analytic therapy (CAT) for young people (aged 13-17) who self-harm, on behalf of the chief investigator. The trial manager will oversee the day-to-day delivery the RELATE-YP (Relational Approach to Working with Young People who Self-Harm) trial. The Post holder will sit as part of the Research Department and the Study team and will be required to Project Manage and deliver this study, under the direction of the Chief Investigator This is a multi-site study and will require collaborative working with all 3 sites across the country to ensure the study is delivered to time and target in line with contractually agreedarrangements with the NIHR and the study partners.
Main duties of the job
The trial manager would lead on the qualitative process evaluation, including the data analysis, write up and publication of this work.The post holder will be expected to work independently according to an agreed plan and under supervision within the Trust's R&D framework and the Principal Investigators for the study.The post holder will communicate with a variety of stakeholders and have advanced organisational skills to prioritise and effectively manage their workload.
About us
We are proud to provide high quality mental health and learning disability services, both inpatient and in the community across five boroughs of Greater Manchester - Bury, Oldham, Rochdale, Stockport and Tameside and Glossop.
Our vision is for a happier and more hopeful life for everyone in our communities and our staff work hard to deliver the very best care for the people who use our services. We're really proud of our#PennineCarePeopleand do everything we can to make sure we're a great place to work.
All individuals regardless of race, age, disability, ethnicity, nationality, gender, gender reassignment, sexual orientation, religion or belief, marriage and civil partnership are encouraged to apply for this post. We would also encourage applications from individuals with a lived experience of mental illness, either individually or as a carer.
If you come and work for us we will offer a range of benefits and opportunities, including:
- Generous annual leave entitlement for Agenda for Change and Medical and Dental staff.
- Flexible working opportunities to support your work/life balance
- Access to Continued Professional Development
- Involvement in improvement and research activities
- Health and Wellbeing activities and access to an excellent staff wellbeing service
- Access to staff discounts across retail, leisure and travel
Job description
Job responsibilities
Monitoring study progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems. Work with the Chief Investigator to ensure that the Study is meeting its targets, isproducing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time. Act as the point of contact for the Study across all external and internal agencies. Planning and organising the complex programme across all three national sites managing the various components of the study including site set up, participant recruitment, data gathering and site close down To liaise with relevant funding bodies, research support network (e.g. NIHR Research Design Service) and R&D departments of partner organisations - including principal investigators, finance, study delivery teams and others Planning and supporting the meetings and work of the various groups and bodies associated with the Study. To support the Chief investigator and other team members with relevant research/administrative activities as required Negotiating contracts and collaboration agreements in conjunction with PCFT senior research coordinator and equivalents at other sites Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit processes. This will include drafting reports for funders, ethics committees andothers Ensure the inclusion of consumer group representatives at the appropriate levels and times. This will be done in partnership with the service user research associate and service user groups across PCFT To work effectively under time-pressure in order to meet tight deadlines and project milestones To provide advice or demonstrate own research activities or workplace routines To organise their own day-to-day tasks and activities; the post holder must be able to take significant responsibility for planning and implementation of specific elements of the research activities conducted within the project. To be aware of national developments, attend national events and undertake any necessary and relevant training to keep up to date with research developments and related issues as required. Comply with data management and quality assurance according to regulatory guidelines (ICH GCP and Data Protection Act 1998). To comply with departmental policies concerning security, safety and patient confidentiality and to ensure that procedures are carried out with safe systems of work and current legislation. Ensure timely reporting of serious adverse events in line with the UK Policy Framework for Health and social care research Ensure decisions of the trial management committee are implemented in a timely manner Overseeing the tracking of participants through the trial and managing the scheduling of assessments. Overseeing randomisation procedures. Promoting the RELATE-YP trial to staff and service users within the Trust and identifying and approaching potential participants. Undertaking non-clinical baseline research assessments with young people taking part in the trial
Job description
Job responsibilities
Monitoring study progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems. Work with the Chief Investigator to ensure that the Study is meeting its targets, isproducing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time. Act as the point of contact for the Study across all external and internal agencies. Planning and organising the complex programme across all three national sites managing the various components of the study including site set up, participant recruitment, data gathering and site close down To liaise with relevant funding bodies, research support network (e.g. NIHR Research Design Service) and R&D departments of partner organisations - including principal investigators, finance, study delivery teams and others Planning and supporting the meetings and work of the various groups and bodies associated with the Study. To support the Chief investigator and other team members with relevant research/administrative activities as required Negotiating contracts and collaboration agreements in conjunction with PCFT senior research coordinator and equivalents at other sites Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit processes. This will include drafting reports for funders, ethics committees andothers Ensure the inclusion of consumer group representatives at the appropriate levels and times. This will be done in partnership with the service user research associate and service user groups across PCFT To work effectively under time-pressure in order to meet tight deadlines and project milestones To provide advice or demonstrate own research activities or workplace routines To organise their own day-to-day tasks and activities; the post holder must be able to take significant responsibility for planning and implementation of specific elements of the research activities conducted within the project. To be aware of national developments, attend national events and undertake any necessary and relevant training to keep up to date with research developments and related issues as required. Comply with data management and quality assurance according to regulatory guidelines (ICH GCP and Data Protection Act 1998). To comply with departmental policies concerning security, safety and patient confidentiality and to ensure that procedures are carried out with safe systems of work and current legislation. Ensure timely reporting of serious adverse events in line with the UK Policy Framework for Health and social care research Ensure decisions of the trial management committee are implemented in a timely manner Overseeing the tracking of participants through the trial and managing the scheduling of assessments. Overseeing randomisation procedures. Promoting the RELATE-YP trial to staff and service users within the Trust and identifying and approaching potential participants. Undertaking non-clinical baseline research assessments with young people taking part in the trial
Person Specification
Education/Qualifications
Essential
- Relevant first degree or equivalent qualification
- Post graduate diploma in related subject, or equivalent experience
- Current Good Clinical Practice certificate (within last 2 years)
Experience
Essential
- Experience undertaking quantitative research
- Experience conducting qualitative research
- Experience of working within a clinical trial
- Demonstrable administration experience
Desirable
- Experience of research within young people's mental health settings
- Experience of management of randomised controlled trials
- Experience of working with higher education institutions
- Expertise of working with colleagues in NHS settings
Knowledge
Essential
- Understanding of risk management procedures within research
- Understanding of confidentiality and data protection within the NHS and/or other healthcare setting/clinical organisation
- Knowledge of research methodologies including trial methodologies
- Knowledge of research ethics and obtaining informed consent.
- Knowledge of the principles of GCP
- Knowledge of research methodologies
Desirable
- Knowledge of research and practice relating to self-harm
Skills
Essential
- Can demonstrate support for the values and beliefs of the Trust
- Able to participate in and contribute to multi-disciplinary team discussions
- Able to participate in and contribute to multi-disciplinary team discussions
- Strong communication and interpersonal skills
- Qualitative data collection and analysis skills
- Ability to manage challenging conversations with parents and young person's / children within context of research
- Ability to establish and maintain effective working relationships with colleagues and members of the Multidisciplinary Team
- IT Skills, including Microsoft Office
- Strong organisational and planning skills.
- Strong skills in administrating research assessments (interviews, questionnaires) with clinical populations
- Good skills with risk management
Desirable
- Skills in managing other research staff
- Skills in quantitative data analysis
Person Specification
Education/Qualifications
Essential
- Relevant first degree or equivalent qualification
- Post graduate diploma in related subject, or equivalent experience
- Current Good Clinical Practice certificate (within last 2 years)
Experience
Essential
- Experience undertaking quantitative research
- Experience conducting qualitative research
- Experience of working within a clinical trial
- Demonstrable administration experience
Desirable
- Experience of research within young people's mental health settings
- Experience of management of randomised controlled trials
- Experience of working with higher education institutions
- Expertise of working with colleagues in NHS settings
Knowledge
Essential
- Understanding of risk management procedures within research
- Understanding of confidentiality and data protection within the NHS and/or other healthcare setting/clinical organisation
- Knowledge of research methodologies including trial methodologies
- Knowledge of research ethics and obtaining informed consent.
- Knowledge of the principles of GCP
- Knowledge of research methodologies
Desirable
- Knowledge of research and practice relating to self-harm
Skills
Essential
- Can demonstrate support for the values and beliefs of the Trust
- Able to participate in and contribute to multi-disciplinary team discussions
- Able to participate in and contribute to multi-disciplinary team discussions
- Strong communication and interpersonal skills
- Qualitative data collection and analysis skills
- Ability to manage challenging conversations with parents and young person's / children within context of research
- Ability to establish and maintain effective working relationships with colleagues and members of the Multidisciplinary Team
- IT Skills, including Microsoft Office
- Strong organisational and planning skills.
- Strong skills in administrating research assessments (interviews, questionnaires) with clinical populations
- Good skills with risk management
Desirable
- Skills in managing other research staff
- Skills in quantitative data analysis
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).