Job summary
This is an exciting opportunity to join our established and experienced clinical research team at Calderdale & Huddersfield NHS Foundation Trust. Due to our success in clinical research and excellent reputation, we have recently become a 'spoke site' for the NIHR Commercial Research Delivery Centre in collaboration with Bradford and Mid Yorkshire NHS Trusts, to improve access to commercial research trials and new treatment options for our patients.
The research governance arrangements of the Trust will be a major function of this post and the post-holder will assist in the co-ordination and monitoring of all aspects of research support. This will include assisting in recording and reporting the Trust's performance in meeting local, regional and national performance targets as well as offering research guidance to new researchers.The post holder must recognise that research and development (R&D) is essential for the advancement of healthcare and understand that the Trust is committed to encouraging staff to pursue high quality, ethical and relevant research and to work within its bounds. The post holder should be passionate about research and show enthusiasm for its advancement.
Main duties of the job
o Carry out full and comprehensive Capacity and Capability Assessments for research studies that require it in a timely manner and prepare for local approval. This includes assessing that research staff are appropriately trained/qualified and that facilities are suitable for research.o Have a full understanding of the requirements for NIHR HRA, MHRA, NRES and research governance review procedures, including knowledge of NHS Support Funding, ICH-GCP and other related research management functions to support researchers.o Assess amendments to ongoing studies for any changes to the resources or facilities required and any effect upon compliance with legislation, policy or guidance and provide recommendations regarding continued study participation.o Provide appropriate RM&G advice and guidance to information requests coming into the research office from external researchers and research organisations.
About us
CHFT is an integrated Trust of 6,500+ colleagues providing hospital and community services to patients and communities across Calderdale and Kirklees. We are rated as 'Good' by the Care Quality Commission, are a top performing Trust for Elective Recovery, Emergency and Cancer Care and widely acknowledged as a national digital lead when it comes to caring for people across our local and regional systems.
Our people are at the core of everything we do, hence our commitment to One Culture of Care. Our focus is to care for and support each other in order to provide outstanding compassionate care to our patients. That is why we are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role.
Job description
Job responsibilities
Review and assess research study contracts, ensuring the Trusts legal position is not compromised. Liaise with research study sponsor or sponsor representatives regarding study costing using appropriate guidance eg AcoRD. Complete industry costing templates and ensure appropriate set up of financial arrangements between funder and Trust finance dept. Take responsibility for own judgements when reviewing research studies. Provide support to research committees and groups as required by the Research Manager.
Be able to interpret complex research protocols and its impact on service. Having the ability to explain these in laymans terms. Post holder will be required to maintain a good working knowledge of legislation as it relates to research, keeping abreast of any new governmental requirements. Pro-actively assist in facilitating potential opportunities for industry sponsored research. Attend conferences and workshops related to the post as requested.
Maintain the EDGE database and the Trusts own research projects database and ensure that the project records are kept up-to-date and accurate. Maintain comprehensive electronic and paper files as appropriate for individual research projects, ensuring that contractual, legal and policy requirements are complied with. Support the Research Manager in performing data integrity reviews and the provision of statistics and performance metrics on all aspects of research activity in the Trust. Assist in building databases for use within the department as required. Interrogate and produce performance reports using EDGE, local databases and national information systems e.g ODP and CPMS as requested. Ensure that Information held and produced for any party is in line with current legislation governing the use of information. (e.g. Freedom of Information Act, GDPR etc) Regular audit and correction of inaccurate information in accordance with Trust procedures.
Contribute to maintaining Standard Operating Procedures, guidance and procedures relating to the research department and the review of these when required by the Research Manager. Contribute to and update the R&D intranet and website pages as required. To assist with any tasks related to funding or grant applications when requested.
Assist in monitoring and audit of research studies and research office processes to ensure that research complies with regulatory standards, including ethically approved consent processes, and Clinical Trials Regulations where applicable. Assist in communicating effectively to ensure that all involved parties understand what is required. Assist in activity required to ensure Department is GCP compliant.
Maintain an efficient filing system of research, document repository and other electronic and paper files. Ensure local and national standards for the speedy processing of research applications are met, reporting potential exceptions to the Research Manager in a timely manner to ensure delays or problems can be overcome. Job is office based and will require post holder to sit at a desk and use a VDU for the majority of their day.
PLEASE READ JOB DESCRIPTION IN FULL.
Job description
Job responsibilities
Review and assess research study contracts, ensuring the Trusts legal position is not compromised. Liaise with research study sponsor or sponsor representatives regarding study costing using appropriate guidance eg AcoRD. Complete industry costing templates and ensure appropriate set up of financial arrangements between funder and Trust finance dept. Take responsibility for own judgements when reviewing research studies. Provide support to research committees and groups as required by the Research Manager.
Be able to interpret complex research protocols and its impact on service. Having the ability to explain these in laymans terms. Post holder will be required to maintain a good working knowledge of legislation as it relates to research, keeping abreast of any new governmental requirements. Pro-actively assist in facilitating potential opportunities for industry sponsored research. Attend conferences and workshops related to the post as requested.
Maintain the EDGE database and the Trusts own research projects database and ensure that the project records are kept up-to-date and accurate. Maintain comprehensive electronic and paper files as appropriate for individual research projects, ensuring that contractual, legal and policy requirements are complied with. Support the Research Manager in performing data integrity reviews and the provision of statistics and performance metrics on all aspects of research activity in the Trust. Assist in building databases for use within the department as required. Interrogate and produce performance reports using EDGE, local databases and national information systems e.g ODP and CPMS as requested. Ensure that Information held and produced for any party is in line with current legislation governing the use of information. (e.g. Freedom of Information Act, GDPR etc) Regular audit and correction of inaccurate information in accordance with Trust procedures.
Contribute to maintaining Standard Operating Procedures, guidance and procedures relating to the research department and the review of these when required by the Research Manager. Contribute to and update the R&D intranet and website pages as required. To assist with any tasks related to funding or grant applications when requested.
Assist in monitoring and audit of research studies and research office processes to ensure that research complies with regulatory standards, including ethically approved consent processes, and Clinical Trials Regulations where applicable. Assist in communicating effectively to ensure that all involved parties understand what is required. Assist in activity required to ensure Department is GCP compliant.
Maintain an efficient filing system of research, document repository and other electronic and paper files. Ensure local and national standards for the speedy processing of research applications are met, reporting potential exceptions to the Research Manager in a timely manner to ensure delays or problems can be overcome. Job is office based and will require post holder to sit at a desk and use a VDU for the majority of their day.
PLEASE READ JOB DESCRIPTION IN FULL.
Person Specification
Qualifications
Essential
- Health or science related degree or equivalent relevant experience
- Competent with IT packages, particularly MS Office applications and Web applications.
- Experience of data manipulation, data analysis and the presentation of results to researchers.
Desirable
- Database manipulation
- Ability to analyse and interpret research management information.
Knowledge
Essential
- Experience of working in a research environment (NHS, University or Industry)
- Project management experience
- Recent significant experience of working in a governance role in a complex or regulated organisation.
- Understanding of Information Governance and Confidentiality and ability to assess complex sets of documents against research governance requirements, with attention to cross referencing of details
- Ability to work under pressure balancing conflicting workloads and working to deadlines.
- Excellent organisational and planning skills and able to produce data charts and performance reports
- Confidence in presenting to multi-disciplinary audiences, be proactive and work methodically with attention to detail and analytical and problem-solving skills
Desirable
- Previous experience of EDGE and knowledge of NHS R&D Approval processes, experience of undertaking research monitoring and experience of leading projects
- Knowledge of indemnity issues in research. Knowledge of commercial organisations impacting on NHS research Knowledge of research costings and contracts Knowledge of legal, regulatory processes & frameworks for NHS research
- An understanding of the monitoring process for research in the NHS. An understanding of performance management GCP qualification
Communication
Essential
- Excellent communication skills (both verbal and written) and interpersonal skills including the ability to build working relationships with department colleagues.
- Ability to work independently with initiative and maintain confidentiality
- Ability to negotiate in a tactful and confident manner to achieve the desired results.
- Excellent teamwork and ability to support colleagues Enthusiastic, professional manner and respectful of others Flexible approach to work
- Ability to work in various locations throughout the network of services provided by Calderdale and Huddersfield NHS Foundation Trust.
Person Specification
Qualifications
Essential
- Health or science related degree or equivalent relevant experience
- Competent with IT packages, particularly MS Office applications and Web applications.
- Experience of data manipulation, data analysis and the presentation of results to researchers.
Desirable
- Database manipulation
- Ability to analyse and interpret research management information.
Knowledge
Essential
- Experience of working in a research environment (NHS, University or Industry)
- Project management experience
- Recent significant experience of working in a governance role in a complex or regulated organisation.
- Understanding of Information Governance and Confidentiality and ability to assess complex sets of documents against research governance requirements, with attention to cross referencing of details
- Ability to work under pressure balancing conflicting workloads and working to deadlines.
- Excellent organisational and planning skills and able to produce data charts and performance reports
- Confidence in presenting to multi-disciplinary audiences, be proactive and work methodically with attention to detail and analytical and problem-solving skills
Desirable
- Previous experience of EDGE and knowledge of NHS R&D Approval processes, experience of undertaking research monitoring and experience of leading projects
- Knowledge of indemnity issues in research. Knowledge of commercial organisations impacting on NHS research Knowledge of research costings and contracts Knowledge of legal, regulatory processes & frameworks for NHS research
- An understanding of the monitoring process for research in the NHS. An understanding of performance management GCP qualification
Communication
Essential
- Excellent communication skills (both verbal and written) and interpersonal skills including the ability to build working relationships with department colleagues.
- Ability to work independently with initiative and maintain confidentiality
- Ability to negotiate in a tactful and confident manner to achieve the desired results.
- Excellent teamwork and ability to support colleagues Enthusiastic, professional manner and respectful of others Flexible approach to work
- Ability to work in various locations throughout the network of services provided by Calderdale and Huddersfield NHS Foundation Trust.
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).
