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Applications are invited for the above full-time post working in Bangor University’s Clinical Trials Unit, the North Wales Centre for Organised Trials in Health and Social Care, (NWORTH).

Applications will also be considered to carry out this role on a part-time or job share basis.

This is an excellent opportunity to join a fast-paced innovative trials unit. The successful candidate will be responsible for the set-up, co-ordination and completion of trials within the unit, including the TOGETHER Trial, (A Randomised Controlled Trial Evaluating the Effectiveness and Cost Effectiveness of “Strengthening Families, Strengthening Communities”, a Community Led Parenting Programme) and VRCOMM (Using Immersive Virtual Reality to Increase levels of Self-Compassion in Patients with Depression). Both are NIHR funded studies looking to evaluate the effectiveness of the developed interventions.

The post holder will be expected to co-ordinate, manage and oversee trials to ensure their continued successful delivery and completion. The successful candidate should be able to demonstrate a good understanding of managing a research study in an academic/NHS setting and ideally have experience of being involved with clinical trials. Excellent communication and presentation skills, together with the ability to organise and motivate others are essential. The post holder will also support the QA and IT functions, where required.

The post-holder will need to be self-motivated, adaptable, a proactive problem-solver, and be able to work effectively in the context of change.

Excellent interpersonal skills are required, as is the ability to work to high standards across a variety of tasks with constant regard to scientific and regulatory requirements. They will demonstrate flair, enthusiasm, innovation and leadership when faced with challenges and will provide operational management in coordination and delivery of the project.

The post-holder will be accountable to the Clinical Trials Unit (CTU) Manager, and will report to and work closely with both the NWORTH CTU Manager and the Chief Investigator(s). Trials on NWORTH portfolio are often led from across the UK with sites around the UK, therefore the post-holder will be expected to travel regularly across all sites and attend key meetings with the Chief Investigators.

A suitable first degree / MSc / PhD or clinical doctorate in a relevant scientific or clinical discipline and/or equivalent experience is essential.

The successful candidate will be expected to commence as soon as possible and the post is available for a period of 12 months. The post may be extended for a further period as the NWORTH portfolio of trials develops.

This role will be located on campus at Bangor. Through our Dynamic Working framework, there will also be the option to spend some time working remotely (although remaining in the UK) to support work life balance, which will be discussed further with candidates at interview.

Prospective applicants are encouraged to contact the following for informal discussions regarding the position: Kirstie Pye, CTU Manager, 01248 382224, [email protected]

Committed To Equal Opportunities

Overview

Bangor University

Bangor is situated in the beautiful area of North West Wales between the mountains of Snowdonia and the famous Menai Straits. It offers unparalleled access to a wide range of outdoor pursuits including, climbing, walking, kayaking and sailing.

With rail and dual carriageway access along the coasts to Liverpool and Manchester and a fast rail route to London, Bangor University’s location enables its staff and students to work and study in unrivalled natural surroundings, whilst still having access to the major conurbations.

Founded in 1884 and dedicated to academic excellence, in the recent Research Exercise Framework, it out-performed expectations in Healthcare Sciences, Psychology and Sports and Exercise Science. Three-quarters of Bangor’s research was classed as either world-leading or internationally excellent, ahead of the average for all UK Universities.

It has over 9,000 students, 26 academic schools and over 550 research-active staff.

College of Human Sciences

The College of Human Sciences is one of three colleges at Bangor University. The College, through the University, is formally linked to the Betsi Cadwaladr University Health Board enabling an integrated approach to developing research, training, medical and healthcare education that serves the needs of North Wales and beyond.

The School of Medical and Health Sciences

The School of Medical and Health Sciences is the University’s main focus for activities that support the healthcare professional workforce.

Our Mission is as follows:

The School mobilises its expertise and experience to generate new solutions to health challenges by engaging with health care research, scholarship, teaching and learning that is of the highest possible standard, quality and value to service users, students, practitioners and stakeholders.

Recognising our bilingual heritage in North Wales, we pay special attention to maintaining language and cultural competence relevant to local, national and international partners.

The Mission statement emphasises our commitment to work in partnership with NHS services and staff, other service providers, patients and the public to create the best possible impact on healthcare and health. Our portfolio supports workforce development, service improvement and research across North Wales, supported by our Bangor and Wrexham campuses.

We host a fully accredited Clinical Trials Unit, with research centres or clusters around health economics, primary care, evidence synthesis, improvement, service user perspectives, rehabilitation, and bilingual aspects of healthcare. We pay attention to demonstrating the links between our research and teaching activities, and in providing our students with excellent learning experiences that equip them with the ability to succeed in their professional careers.

North Wales Organisation for Randomised Trials in Health (NWORTH)

The North Wales Organisation for Randomised Trials in Health is a clinical trials unit (CTU) which has full UKCRC registration and is one of the elements within the Health and Care Research Wales Infrastructure. The CTU is part funded by the Welsh Government, with key members of the team funded by an infrastructure grant from Health and Care Research Wales.

The Project

The TOGETHER Project

TOGETHER will evaluate an established, universal, inclusive group-based programme for parents of children aged 3-18 years, organised by a charitable organisation, the race Equality Foundation that promotes race equality in the UK.

Across urban areas of England where ethnically and socially mixed communities live, the parenting programme will be offered to families who either decide themselves that they need help or families referred by professionals for help. In total 676 parents agreeing to take part in the study will be randomly allocated to either immediately starting the programme or having to wait for a 10-month period before starting it. All the parents agreeing to take part in the study will be interviewed by phone at the start, after the programme has been completed and then 6 months later.

A smaller number of parents and staff involved in delivering the programme will be interviewed about their views and experiences of it.

VR COMM Project

Excessive self-criticism is one of the most significant psychological processes thought to influence the susceptibility to and maintenance of depression. Self-compassion can provide balance to feelings of self-criticism through self-acceptance and self-soothing and thus, can be viewed as a natural modulator of self-criticism.

Virtual reality (VR) technology can be used to foster self-compassion and decrease self-criticism in both self-critical individuals recruited from community samples and in patients with depression. The intervention has been developed into a 4-session treatment for depression and will now be tested in a feasibility study leading onto a definitive effectiveness trial.

Main Duties and Responsibilities

Trial management

To ensure the overall efficient day-to-day co-ordination and management of the study.
Establish appropriate procedures to ensure adherence to trial protocols and administrative requirements; create and maintain all trial files, including the trial master file and investigator site files.
Ensure that all staff working on the trial are qualified and trained to fulfil the duties assigned to them and to maintain an up-to-date record of staff training and CVs.
Create and maintain trial master file (TMF), and oversight of site files and maintain an auditable record of these approvals and all other essential documents in the TMF.
Contribute to the development and delivery of training for the research team.
Ensure the inclusion of user engagement, involvement and representation at the appropriate levels and times.
Work with the Research Associate to monitor and report on the recruitment of trial participants, secure randomisation processes, and accrual, and ensure subsequent efficient and effective data management.
Monitor trial progress to ensure compliance with and adherence to the project plan, and identify, evaluate and rectify problems.
Act as the point of contact for all external and internal agencies.
Maintain an auditable record of the duties assigned to the CI and trial staff, qualifications they hold, and the training they receive, including training in the currently approved protocol, GCP and relevant legislation.
Develop and maintain the risk assessment in conjunction with the CI and relevant NWORTH staff.
Conduct activities within the trial monitoring plan.
Co-ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
Ensure excellent communication both within and outside the team; for example, provision of regular and ‘ad hoc’ information, both written and verbal, to study participants and key stakeholders, to include reports, updates, guidance notes, etc.
Liaise with and coordinate the Trials Steering Committee and Data Monitoring and Ethics Committee.
Work with the Chief Investigator and CTU Manager to ensure that the trial is meeting its targets and producing meaningful outputs; predict and plan for any changes that warrant requests to changes in protocol, funding or time.
Plan and support the meetings and work of the various groups and bodies associated with the trial.
Encourage decision making and advise the TMG in discussions about the intervention, the outcome measures, and practicalities of the project.
Liaise with all team members to encourage them in their responsibilities.
Liaise with the Trial Unit Statisticians, IT Team and Data Managers regarding data analysis and reports.
Implement quality assurance procedures designed to ensure and record that all study data are as accurate, complete and verifiable as the study resources permit.
Maintain an auditable record of all approvals and all other essential documents.

Quality Assurance Support

Assist with internal audits, including compiling checklists, conducting audits, and writing audit reports.
Assist with maintenance and review of Standard Operating Procedures (SOPs) and Work Instructions (WI).
Assist with archiving.

IT support

Undertake the development, testing, and validation of MACRO databases.
Provide IT support of NWORTH-managed systems to NWORTH CTU staff and supported research staff.

Other Duties and Responsibilities

The list of main duties and responsibilities is not meant to be exhaustive, but merely an indication of the main areas of activity for the post. It may be amended or added to, at the discretion of the Director of NWORTH with other duties commensurate with the role function and grade following consultation with the post holder.

• Maintain the security of research data obtained and observe confidentiality at all times regarding participants and their involvement.

• Ensuring compliance with research and clinical governance guidelines, data protection and ethical requirements.

• The post holder will be expected to participate in performance review and developmental activities.

• The post holder will be expected to comply with the University’s equality policies and statements, Dignity at Work and Study Policy and the University’s Welsh Language Scheme.

• The post holder has a general and legal duty of care in relation to health, safety and wellbeing and must take all reasonable steps to ensure a safe and healthy working environment for him/her self and for other members of staff, students and visitors affected by his/her actions or inactions. The post holder is also required to comply with all applicable health and safety policies, procedures and risk assessments.

• The post holder must comply with relevant legal and financial policies and procedures and be aware of their responsibilities in terms of the legal requirements of their posts.

Person Specification

Qualifications/Training

Essential

A suitable first degree / MSc / PhD or clinical doctorate in a relevant scientific or clinical discipline and/or equivalent experience.
Training in Good Clinical Practice with an in-depth understanding and knowledge of regulatory requirements.

Experience

Essential

Strong scientific background with experience of working in the health services / social care / public health research field.
Experience of project delivery, project/research management.

Desirable

Experience of managing research projects in health or social care settings.
Previous experience of working as a clinical trials manager/co-ordinator.
Experience of applying for ethical approval for clinical research projects within the NHS .
Experience of managing NHS research governance requirements.
Experience of parenting programmes or research/evaluation of these.

Skills/Abilities

Essential

Good generic research skills.
Experience of writing for publication or contributing to funding applications.
Excellent organisational skills; able to manage own work and that of other team members, and meet project targets.
Excellent communication skills at a range of levels conveying information in academic and non-academic contexts.
Excellent IT skills, including use of the Microsoft Office package.
Able to make good relationships with colleagues and to work well as part of a team.
Excellent attention to detail.

Desirable

Experience of recruiting research participants, collecting data, administering standardised assessments, and managing complex data sets in health or social care settings.
Experience of writing procedures and reports.
Capability to publish research in peer-reviewed journals of international standard.
Capability to develop and manage research projects, and to disseminate results through presentation at relevant conferences and publication in relevant journals.
Experience of multidisciplinary working within an academic or NHS context.
Able to develop constructive relationships with research participants and carers, with staff in relevant statutory and voluntary agencies, and with members of user and carer groups.

Other

Essential

Able to travel to all the research sites located throughout England and to regularly attend meetings in other parts of the UK, (mainly London).
Able to demonstrate an understanding of the bilingual nature of the institution and the area.

General

The University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We strive to develop a workforce from all sections of the community regardless of sex, gender identity, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. We promote and facilitate the use of the Welsh language through our progressive Welsh Language Policy. We comply with the Welsh Language Standards and are committed to equality of opportunity. You are welcome to apply for any job in English or Welsh and all applications submitted will be treated equally.

We are a member of Advance HE's Athena SWAN Gender Equality charter and hold a Bronze award in recognition of our commitment to and progress towards gender equality within the University's policies, practices, and culture. We are proud to be a Disability Confident employer.

All members of staff have a duty to ensure their actions are in line with the overall environmental aims of the University and minimise their environmental impact.

All offers are made subject to proof of eligibility to work in the UK and receipt of satisfactory references.

All candidates must meet the requirements of UK ‘right to work’ requirements *** If you require Home Office permission to work in the UK, or need to switch your visa status in order to take this job we recommend you use the following link to information about the routes into employment and to check eligibility requirements: -visas">https://www.gov.uk/browse/visas-immigration/work-visas

Please note that we are unable to employ anyone who does not have the right to live and work in the UK legally. When applying for this post you will be required to explain the basis upon which you believe you will be able to live and work in the UK legally on the commencement date of the role should your application be successful.

Candidates should also note that they may be required to apply for an ATAS certificate (Academic Approval Technology Scheme) from the Counter-Proliferation and Arms Control Centre of the Foreign, Commonwealth and Development Office before being able to apply for a visa - -approval-scheme">https://www.gov.uk/guidance/academic-technology-approval-scheme

Please note that, in the event of applications being received from candidates on the University's Redeployment Register with a reasonable skills match to the post specification, these applicants will be given prior consideration.