Job summary
The Bipolar At Risk Trial II (BART II) is an Efficacy and Mechanism Evaluation trial which has been awarded by the National Institute for Health Research (NIHR). The post holder will be working in a highly novel area of prevention with a team of leading experts in bipolar disorder including those with lived experience. The aim of BART II is to investigate Cognitive Behavioural Therapy for those considered "at risk" for bipolar disorder, and to help shape NHS services for this population group. Data from this study will inform service development.
An exciting opportunity has arisen to join the research team based in the Research Development Unit. We are seeking a full time Research Assistant/Nurse/AHP who will work on the BART II clinical research project. The post would suit individuals with experience of recruitment into clinical studies who are considering pursuing a career in research.
The Researcher will work under the supervision and reporting to the Research Delivery Manager in the RDU, as part of a team managing and delivering a range of clinical research projects including commercial research.
You should be enthusiastic, dynamic, have a willingness to learn new skills and a genuine interest in research, research development and evidenced based practice.
You will need specialist knowledge in mental health and an understanding of research methodologies. Clinical research skills and additional research training are desirable though training will be provided.
Main duties of the job
The post holder will work as part of the larger research team to develop and deliver recruitment targets and strategies to meet these ensuring that research safeguards are in place to protect the well-being of research participants and that research is conducted within ICH Good Clinical Practice Guidelines for Research. The post holder will be expected to work flexibly across SHSC in response to the needs of the research project.
Under supervision you will:
- assess the suitability of patients to take part in the BART II clinical trial
- provide patients taking part in the study with specialist information regarding their participation
- provide high standards and continuity of care for participants during the research study
- work as part of a team to co-ordinate and manage the research within expected timelines
- participate in the process of initial and on-going informed consent for the research participant prior to carrying out procedures and treatments as agreed within the protocols
- To complete research outcome measures with participants and collect data with close attention to detail and accuracy
- To upload source data in to study specific and national databases
- Liaise closely with the principal investigator/research team and other services involved in the delivery of research studies
About us
We are passionate about providing the very best care to the people we support, and we're looking for amazing people who share this passion to join us.
What is it that makes our Trust such a special place to work? Well, it's all about the people. Our staff, service users, carers and families all come from such diverse backgrounds and all have expertise and stories to share.
It's important that you feel supported in your role, that the people who you work with are as passionate as you are and that your health and wellbeing is taken care of
If you're interested in developing your career, you'll have access to a range of training and education opportunities, including apprenticeships, work experience and placements, as well as the chance to get involved in research.
We are all very proud of the difference we make to people's lives each and every day and if that's something that you'd like to be part of we'd love to have you with us.
Job description
Job responsibilities
Under supervision the research nurse/research assistant will take responsibility:
- To maintain a suitable environment to promote the well-being and safety of patients, participants and staff, identifying the need for further risk assessment where necessary.
- To assess the suitability of patients to take part in clinical trials.
- To provide patients taking part in clinical trials with specialist information regarding their participation, including risk.
- To provide high standards and continuity of care for participants during the research study, maintaining lines of communication with clinical staff.
- To act as a resource to patients, their families and staff from within the clinical area, and to act as an effective referral to other support agencies where necessary.
- To achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken.
- To work within SHSCs dedicated research teams.
- To organise and manage defined procedures, assist with interventional treatments and record the resulting information.
- To possess theoretical knowledge of the relevant disease process and to ensure that all theoretical and practical knowledge relating to disease process is developed and maintained.
Research
- As part of the role you will develop knowledge and skills to become a competent research practitioner through research training opportunities.
- To possess knowledge of Research Governance, GCP and current legislation relating to research.
- To demonstrate knowledge of the ethical principles for clinical research and its impact on current practice.
- To be able to outline the roles of the Health Research Authority and Research Ethics Committees (RECs).
- To demonstrate a working knowledge of research terminology, methodology and study design.
- To assist in the conduct of research to recognised standards and regulations as laid down by governing bodies of the UK and internationally.
- To ensure ethical and clinical safe practice.
- To work as part of a team to co-ordinate and manage research within expected timelines.
- To work within and contribute towards the development and review of Standard Operating Procedures (SOPs) for research.
- To attend Investigator Meetings where applicable
- To support actively the process of gaining ethics approval for research studies.
- To understand the requirements of the study protocol and to adhere to them.
- To work in conjunction with the site investigator and more senior colleagues in identifying, screening and recruiting research participants.
- To pay meticulous attention to detail when preparing patient documentation, completing accurate records of patient care, maintaining source data and case report forms (CRF)in a clearly trackable system, to ensure data validity.
- Upload data to the RDU Local Performance Monitoring System (EDGE)
- To report potential Serious Adverse Events (SAEs) to a senior member of the research nurse team to establish need for escalation.
- To provide ongoing support, advice and information to patients/volunteers with regard to their participation in clinical research.
- To participate in the process of initial and ongoing informed consent of the trial participant prior to carrying out procedures and treatments as agreed within the trial protocol.
- To co-ordinate participant visits.
Communication
- To liaise closely with the Principal Investigator/Research Team, and clinical services
- To liaise with the clinical trial personnel from the research sponsors regarding ethical, organisational, managerial, monitoring and financial aspects of the trial.
- To facilitate communication between the research sponsor and clinical services involved in the research.
- To communicate effectively with research participants on aspects of a clinical research.
Education
- To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness and to actively maintain a Personal Development Portfolio (PDP).
- To identify own professional development needs through active participation in the Trust Personal Development Review (PDR) process.
- To act as a resource to directorate staff regarding individual research projects and the research submission pathway.
Management
- To manage under supervision the organisation of own workload within clinical trial requirements.
- To conduct trial-related activities that contributes to the overall co-ordination of the individual research projects.
- To ensure that policies and procedures of the Trust are adhered to, to work within the NMC professional code of conduct for nurses, midwives and health visitors, and to work within own scope of practice.
- To undertake the practical organisation and management of trial participants and the administration of information.
- To ensure that updates and amendments are reported in a timely fashion.
Job description
Job responsibilities
Under supervision the research nurse/research assistant will take responsibility:
- To maintain a suitable environment to promote the well-being and safety of patients, participants and staff, identifying the need for further risk assessment where necessary.
- To assess the suitability of patients to take part in clinical trials.
- To provide patients taking part in clinical trials with specialist information regarding their participation, including risk.
- To provide high standards and continuity of care for participants during the research study, maintaining lines of communication with clinical staff.
- To act as a resource to patients, their families and staff from within the clinical area, and to act as an effective referral to other support agencies where necessary.
- To achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken.
- To work within SHSCs dedicated research teams.
- To organise and manage defined procedures, assist with interventional treatments and record the resulting information.
- To possess theoretical knowledge of the relevant disease process and to ensure that all theoretical and practical knowledge relating to disease process is developed and maintained.
Research
- As part of the role you will develop knowledge and skills to become a competent research practitioner through research training opportunities.
- To possess knowledge of Research Governance, GCP and current legislation relating to research.
- To demonstrate knowledge of the ethical principles for clinical research and its impact on current practice.
- To be able to outline the roles of the Health Research Authority and Research Ethics Committees (RECs).
- To demonstrate a working knowledge of research terminology, methodology and study design.
- To assist in the conduct of research to recognised standards and regulations as laid down by governing bodies of the UK and internationally.
- To ensure ethical and clinical safe practice.
- To work as part of a team to co-ordinate and manage research within expected timelines.
- To work within and contribute towards the development and review of Standard Operating Procedures (SOPs) for research.
- To attend Investigator Meetings where applicable
- To support actively the process of gaining ethics approval for research studies.
- To understand the requirements of the study protocol and to adhere to them.
- To work in conjunction with the site investigator and more senior colleagues in identifying, screening and recruiting research participants.
- To pay meticulous attention to detail when preparing patient documentation, completing accurate records of patient care, maintaining source data and case report forms (CRF)in a clearly trackable system, to ensure data validity.
- Upload data to the RDU Local Performance Monitoring System (EDGE)
- To report potential Serious Adverse Events (SAEs) to a senior member of the research nurse team to establish need for escalation.
- To provide ongoing support, advice and information to patients/volunteers with regard to their participation in clinical research.
- To participate in the process of initial and ongoing informed consent of the trial participant prior to carrying out procedures and treatments as agreed within the trial protocol.
- To co-ordinate participant visits.
Communication
- To liaise closely with the Principal Investigator/Research Team, and clinical services
- To liaise with the clinical trial personnel from the research sponsors regarding ethical, organisational, managerial, monitoring and financial aspects of the trial.
- To facilitate communication between the research sponsor and clinical services involved in the research.
- To communicate effectively with research participants on aspects of a clinical research.
Education
- To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness and to actively maintain a Personal Development Portfolio (PDP).
- To identify own professional development needs through active participation in the Trust Personal Development Review (PDR) process.
- To act as a resource to directorate staff regarding individual research projects and the research submission pathway.
Management
- To manage under supervision the organisation of own workload within clinical trial requirements.
- To conduct trial-related activities that contributes to the overall co-ordination of the individual research projects.
- To ensure that policies and procedures of the Trust are adhered to, to work within the NMC professional code of conduct for nurses, midwives and health visitors, and to work within own scope of practice.
- To undertake the practical organisation and management of trial participants and the administration of information.
- To ensure that updates and amendments are reported in a timely fashion.
Person Specification
Knowledge and Skills
Essential
- Specialist mental health knowledge and experience of working within a mental health setting
- Understanding of the national and local health and social care environment
- Experience of communicating complex information with service users and carers
- Understanding of basic research skills and methodologies
Desirable
- Knowledge and understanding of the mental health research agenda
- Understanding of GCP, HRA and ethical considerations
- Understanding of NHS Research Management and Governance and NHS Ethics processes
Training and Qualifications
Essential
- RGN/RN Mental Health with current valid registration with the NMC (for Research Nurse only)
- Degree (or equivalent qualification) in a subject relevant to mental health research or mental health professional qualification
- Clinical Registration
Desirable
- Good Clinical Practice
- Evidence of additional research training skills
Experience
Essential
- Experience of working independently and being part of a dispersed team
- Experience in working with Mental health service users and carers
Desirable
- Experience of working in a clinical research environment
- Experience of successful participation in research projects
Other
Essential
- Ability to manage own workload
- Demonstrated ability to organise time and workload across projects and to work flexibly where the pattern of work is unpredictable
- Good communication skills, both verbal and written, including ability to use Microsoft applications including Word, Excel and Powerpoint.
- Ability to work on own initiative.
- Advanced organisational skills.
- Excellent inter-disciplinary/ interagency communication skills.
- Adaptable and self-motivated.
- Excellent interpersonal skills.
- Proactive, self-directed learner.
- Proven administrative skills.
Person Specification
Knowledge and Skills
Essential
- Specialist mental health knowledge and experience of working within a mental health setting
- Understanding of the national and local health and social care environment
- Experience of communicating complex information with service users and carers
- Understanding of basic research skills and methodologies
Desirable
- Knowledge and understanding of the mental health research agenda
- Understanding of GCP, HRA and ethical considerations
- Understanding of NHS Research Management and Governance and NHS Ethics processes
Training and Qualifications
Essential
- RGN/RN Mental Health with current valid registration with the NMC (for Research Nurse only)
- Degree (or equivalent qualification) in a subject relevant to mental health research or mental health professional qualification
- Clinical Registration
Desirable
- Good Clinical Practice
- Evidence of additional research training skills
Experience
Essential
- Experience of working independently and being part of a dispersed team
- Experience in working with Mental health service users and carers
Desirable
- Experience of working in a clinical research environment
- Experience of successful participation in research projects
Other
Essential
- Ability to manage own workload
- Demonstrated ability to organise time and workload across projects and to work flexibly where the pattern of work is unpredictable
- Good communication skills, both verbal and written, including ability to use Microsoft applications including Word, Excel and Powerpoint.
- Ability to work on own initiative.
- Advanced organisational skills.
- Excellent inter-disciplinary/ interagency communication skills.
- Adaptable and self-motivated.
- Excellent interpersonal skills.
- Proactive, self-directed learner.
- Proven administrative skills.
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
