Job summary
Are you looking for a new challenge in an environment where no two days are the same? Do you want to make a difference to patient care? The Research and Development team at BCUHB are a friendly, established team who wish to recruit a research facilitator who is enthusiastic and committed to joining the team. Training will be offered to undertake the role, and there will be opportunities on offer.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
Main duties of the job
The post holder will implement systems to establish a culture where researchers are supported to perform good quality research with the dignity, rights, safety and well-being of participants being protected.
Manage, with the support of the Research Manager, the local confirmation process, providing support to Investigators in setting up appropriate research management systems that comply with the Research Governance Policy Framework at the outset of the research process.
Responsible for quality assurance and quality control processes through monitoring and auditing research activity, conducting performance reviews to ensure research practice meets the quality and standards set out in the UK Policy Framework for Health and Social Care Research. They will be a member of the Research team who provide support in all aspects of research initiatives for organisational wide staff. To supervise junior administrative staff in the Research Office, provide a comprehensive advice and support service to all staff within the organisation who are involved in undertaking research.
About us
If you relish a challenge, have a passion to help others or simply fancy a fresh start, then Betsi Cadwaladr University Health Board (BCUHB) North Wales, has all the right ingredients. The largest health organisation in Wales, providing a full range of primary, community, mental health, acute and elective hospital services for a population of around 700,000, across North Wales . Join our team and get the support you need, in line with our Organisational Values and 'Proud to Lead' competence framework.
Enjoy being part of working with engaged leadership at all levels, and be assured we are committed to promoting equality and diversity, and are proud to welcome applicants under the "Disability Confident Employer" scheme.
Please check your email account regularly. Successful applicants will receive all recruitment related correspondence via the email account registered on the application form.
Applications may be submitted in Welsh. Applications submitted in Welsh will not be treated less favourably than an application submitted in English.
Job description
Job responsibilities
Research management and project set up
- Provide and receive complex and sensitive research information. This requires judging a range of factors or situations and comparison of a range of options depending on the level of each research project, in order to meet the requirements of the Research Governance management and processes.
- Work closely with the Health Research Authority and Health and Care Research Wales in granting local confirmation for projects to commence. Assess individual submissions based on complex components (type of research, regulatory requirements) and decide, comparing a range of options, the appropriate course of action for approval.
- Be responsible for specific pre-delivery checks for each study registered.
- Work closely with Research Administrators and other research team members to adapt and improve the local research set up processes.
- Instigate the production of research passports for researchers who are not NHS employees and keep track of progress. Record all research passports and subsequently issued honorary research contracts or letters of access as appropriate, linking to the appropriate research master files.
- Provide support to Principal Investigators in setting up appropriate research management systems that comply with the UK Policy Framework for Health and Social Care Research at the outset of the research process.
- Lead on the input of local study specific information on Local Project management system. Ensure the quality of research database information.
Audit and monitoring
- Ensure that research projects are reviewed, audited and monitored on a timely basis and obtain the regulatory approvals as defined by policies, protocols and procedures. This requires working with a range of routine and non-routine procedures and practices to ensure that all regulatory approvals have been sought and obtained for each project active in BCUHB which are being managed from the Research office.
- Undertake appropriate auditing and monitoring activities as required as part of the Research Quality System to ensure the standards required for all research projects are carried out in line with their research proposal as agreed by approving body and are in line with Research Governance for Health and Social Care, for the duration of the life of each project.
- Audit active research projects within the Health Board in line with the requirements of the Health Board research monitoring/risk procedures. Ensure data resulting from research audits is entered onto the research management database and prepare reports summarising the findings. Follow up audit findings and ensure recommended actions are implemented.
- Promote the development and implementation of Health research Policies, Standard Operating Procedures and Guidelines within BCUHB against which research practice is assessed and monitored to ensure co-ordination of Research Governance with other initiatives of BCUHB and its partners.
- Support and give advice to researchers of varying levels of seniority both internal and external to the Health Board to fulfil Health Board Health research policies and standard operating procedures with regard to undertaking research.
- Co-ordinate, implement and maintain audit schedules/programmes, as managed by the Research Manager. This includes a rolling programme of audits of research management related systems and support departments to ensure compliance and effective handling of research related issues, and conduct comprehensive assessments of research practice, based on the standards developed and regulatory framework (EU/UK Law). Gathering, analysing, interpreting and presenting the data and information resulting from the audits.
- Plan and organise complex programmes of monitoring studies progress and final reports, record the data obtained from reports and disseminate information appropriately.
- Provide assistance, support and advice to BCUHB own account research projects (collate data, data input, assist with randomisation procedures, produce and revise documentation content, with guidance from Research manager for specific projects)
Archiving
Maintains oversight for the archiving of all documents relating to all Sponsored and Hosted studies within the Health Board.
Follows local Standard Operating Procedures for preparing, storing and accessing materials to be archived.
Administers the Iron Mountain Connect system, granting access to the site, retrieving boxes, return of boxes to iron mountain, paying invoices and monitoring spend on account, carrying out audits of the site as well as annual box audits. Arranging return and destruction of studies when required following the Health Board policy for disposal of confidential waste.
Training
- Identify training needs amongst Health board researchers.
- Provide general Research information advice and guidance to researchers from BCUHB and University, (including patient and public representatives, service users, Doctors in training and of all grades), on the research governance processes. Disseminate this information and update ensuring all new developments in Research are communicated and placed on the BCUHB website.
- Produce presentations for training purposes for researchers of all grades.
Regularly provide Good Clinical Practice training and practical training and advice to researchers.
Job description
Job responsibilities
Research management and project set up
- Provide and receive complex and sensitive research information. This requires judging a range of factors or situations and comparison of a range of options depending on the level of each research project, in order to meet the requirements of the Research Governance management and processes.
- Work closely with the Health Research Authority and Health and Care Research Wales in granting local confirmation for projects to commence. Assess individual submissions based on complex components (type of research, regulatory requirements) and decide, comparing a range of options, the appropriate course of action for approval.
- Be responsible for specific pre-delivery checks for each study registered.
- Work closely with Research Administrators and other research team members to adapt and improve the local research set up processes.
- Instigate the production of research passports for researchers who are not NHS employees and keep track of progress. Record all research passports and subsequently issued honorary research contracts or letters of access as appropriate, linking to the appropriate research master files.
- Provide support to Principal Investigators in setting up appropriate research management systems that comply with the UK Policy Framework for Health and Social Care Research at the outset of the research process.
- Lead on the input of local study specific information on Local Project management system. Ensure the quality of research database information.
Audit and monitoring
- Ensure that research projects are reviewed, audited and monitored on a timely basis and obtain the regulatory approvals as defined by policies, protocols and procedures. This requires working with a range of routine and non-routine procedures and practices to ensure that all regulatory approvals have been sought and obtained for each project active in BCUHB which are being managed from the Research office.
- Undertake appropriate auditing and monitoring activities as required as part of the Research Quality System to ensure the standards required for all research projects are carried out in line with their research proposal as agreed by approving body and are in line with Research Governance for Health and Social Care, for the duration of the life of each project.
- Audit active research projects within the Health Board in line with the requirements of the Health Board research monitoring/risk procedures. Ensure data resulting from research audits is entered onto the research management database and prepare reports summarising the findings. Follow up audit findings and ensure recommended actions are implemented.
- Promote the development and implementation of Health research Policies, Standard Operating Procedures and Guidelines within BCUHB against which research practice is assessed and monitored to ensure co-ordination of Research Governance with other initiatives of BCUHB and its partners.
- Support and give advice to researchers of varying levels of seniority both internal and external to the Health Board to fulfil Health Board Health research policies and standard operating procedures with regard to undertaking research.
- Co-ordinate, implement and maintain audit schedules/programmes, as managed by the Research Manager. This includes a rolling programme of audits of research management related systems and support departments to ensure compliance and effective handling of research related issues, and conduct comprehensive assessments of research practice, based on the standards developed and regulatory framework (EU/UK Law). Gathering, analysing, interpreting and presenting the data and information resulting from the audits.
- Plan and organise complex programmes of monitoring studies progress and final reports, record the data obtained from reports and disseminate information appropriately.
- Provide assistance, support and advice to BCUHB own account research projects (collate data, data input, assist with randomisation procedures, produce and revise documentation content, with guidance from Research manager for specific projects)
Archiving
Maintains oversight for the archiving of all documents relating to all Sponsored and Hosted studies within the Health Board.
Follows local Standard Operating Procedures for preparing, storing and accessing materials to be archived.
Administers the Iron Mountain Connect system, granting access to the site, retrieving boxes, return of boxes to iron mountain, paying invoices and monitoring spend on account, carrying out audits of the site as well as annual box audits. Arranging return and destruction of studies when required following the Health Board policy for disposal of confidential waste.
Training
- Identify training needs amongst Health board researchers.
- Provide general Research information advice and guidance to researchers from BCUHB and University, (including patient and public representatives, service users, Doctors in training and of all grades), on the research governance processes. Disseminate this information and update ensuring all new developments in Research are communicated and placed on the BCUHB website.
- Produce presentations for training purposes for researchers of all grades.
Regularly provide Good Clinical Practice training and practical training and advice to researchers.
Person Specification
Qualifications
Essential
- Undergraduate degree (e.g. BSc) in social science, research or management or equivalent NHS experience. ?Knowledge of Research Governance and legislative framework for conducting clinical research studies, including Good Clinical Practice. ?Knowledge of current national systems and structures for the approval, management and understanding of monitoring of clinical research in the NHS. ?Understanding of clinical trial procedures- commercial and non-commercial. ?Research and/or research management skills
Experience
Essential
- Significant experience of working in Research Governance processes in the NHS ?Project management experience ?Proven experience of working as part of a team ?Experience of writing and implementing Standard Operating procedures
Experience
Desirable
- Report writing ?Evidence of multi-professional team working
Person Specification
Qualifications
Essential
- Undergraduate degree (e.g. BSc) in social science, research or management or equivalent NHS experience. ?Knowledge of Research Governance and legislative framework for conducting clinical research studies, including Good Clinical Practice. ?Knowledge of current national systems and structures for the approval, management and understanding of monitoring of clinical research in the NHS. ?Understanding of clinical trial procedures- commercial and non-commercial. ?Research and/or research management skills
Experience
Essential
- Significant experience of working in Research Governance processes in the NHS ?Project management experience ?Proven experience of working as part of a team ?Experience of writing and implementing Standard Operating procedures
Experience
Desirable
- Report writing ?Evidence of multi-professional team working
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).
