Job summary
The post-holder will be a member of the NUH R&I department. The post holder will be responsible for a portfolio of research projects sponsored by NUH. The post holder will be responsible for this portfolio of studies throughout the different stages of the sponsorship management process: feasibility, risk assessment, confirmation of capacity, ethical & governance review and study set up, monitoring compliance to Good Clinical Practice (GCP), audit and inspection and finally study closure.The post holder will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams with a focus on NUH sponsored studies.The post holder will also participate in preparing for external audits and MHRA inspections.
Main duties of the job
The post of SRGF is central to our commitment to deliver research studies of the highest quality to time and targeto The post holder will contribute to the preparation and review of R&I policies.o The post holder will contribute to the preparation, review and writing of standard operating procedures and other study related documents.o The post holder will establish and maintain effective working relationships with all relevant organisations and individuals, including key service support departments within the Trust, East Midlands CRN, other UKCRN research networks, other providers of NHS services within the LCRN, local Higher Education Institutions, Industry, and NHS commissioners.o The post-holder will maintain a strong and current working knowledge of developments regarding clinical research management, regulation and governance, NHS structures and services and inform and guide R&I staff accordingly.o The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.o The post holder will be involved in the implementation of assigned Corrective Action Preventative Actions (CAPA) plan(s), within their respective areas.The post holder will work with study teams as a representative of NUH acting as the research study sponsor and will oversee the application process for appropriate study approvals.More specifically, the post holder will support the Head of Research Governance, Quality and Integrity
About us
NUH sponsors and hosts a comprehensive portfolio of research projects. NUH works in close partnership with the East Midlands Clinical Research Network (CRN) to provide a timely, proportionate and pragmatic research approvals service for both portfolio and non-portfolio studies conducted within NUH. The Trust has established robust pharmacovigilance and quality assurance systems in order to ensure patient safety and data quality during the conduct of clinical trials.The post-holder will be a member of the NUH R&I department. The post holder will be responsible for a portfolio of research projects sponsored by NUH. The post holder will be responsible for this portfolio of studies throughout the different stages of the sponsorship management process: feasibility, risk assessment, confirmation of capacity, ethical & governance review and study set up, monitoring compliance to Good Clinical Practice (GCP), audit and inspection and finally study closure.The post holder will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams with a focus on NUH sponsored studies.
Job description
Job responsibilities
SPONSORSHIP APPLICATIONS AND APPROVALS Act as the sponsor point of contact within NUH and for outside organisations. Work closely with the Divisional R&I teams to ensure that the required sponsorship research milestones are identified and costed for during the grant application process. Review medical device Technical Files to ensure all regulatory essential requirements are met. Review sponsorship requests in accordance with NUH policy, with the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP) and appropriate Clinical Trials/medical device Regulations. Engage with other teams within R&I, NUH and other organisations to ensure the feasibility of the study. Perform study feasibilities, risk assessments and complete Schedule of Events for NUH sponsored studies. Support research teams to assess capacity and capability to deliver the proposed NUH sponsored study at NUH. Liaise with the R&I Research Contracts team to ensure the legal requirements of the study are met and that appropriate contracts and insurance are in place prior to research commencing at any site. Ensure all study vendors are reviewed in accordance with Vendor Management process. Work with study teams to develop documentation required for the study and support the researcher during the submission to the relevant approval bodies via IRAS. Support and facilitate queries from relevant approval bodies. Ensure sponsorship data is captured in Documas. Effectively disseminate information on research governance procedures to all staff, independent contractors, researchers, service users, carers and members of the public. Work within Trust-wide policies and procedures relating to Research and Research management where appropriate, working to ensure that documents are prepared to a high standard and delivered on time.STUDY SPONSORSHIP MANAGEMENT Work with R&I finance to ensure all research study budgets, costs and funding sources are appopriately managed and a clear audit trail maintained. Support research-related financial management in NUH. This includes working with the R&IDivisional Team to maintain appropriate financial systems to support research and R&I income where required. Maintain sponsor files and Trial Master Files (electronic and hard copy) in accordance with GCP essential requirements. Support the research teams in identifying and resolving barriers for the delivery of NUH sponsored research projects and escalating issues as appropriate. Support the management and set-up of multi-site studies (where appropriate) by working with the CI and their team and liaising with other site investigators. Co-ordinate and facilitate Site Initiation visits for NUH sponsored research. Ensure all queries and issues are addressed prior to issuing C&C/greenlight. Prepare and implement a risk based and robust monitoring plan for studies sponsored by NUH. Act as a clinical trials monitor, by conducting ongoing monitoring visits for NUH sponsored studies according to their monitoring plan, where applicable. Support and facilitate the close out of monitoring queries. Facilitate GCP and R&I SOP training. Ensure training records for research teams are up to date. Act as R&I pharmacovigilance facilitator for CTIMPs by ensuring:o SAE reports are processed and sent to medical monitor, all follow- up reports are processed and reviewed by the medical monitor. All SAEs are reconciled on a regular basis. If required, ensure SUSARs are reported to the MHRA within the timelines. Support the study team in preparing amendments, ensure all study amendments are reviewed and classified correctly i.e. minor or substantial. Support the submission of amendments to the relevant approval body. And address queries from the relevant approval bodies. Review and approve all protocol deviations, violations and breaches. Report violations and breaches to the relevant approval bodies. Support the research team to investigate root causes and implementation of corrective and preventative actions. Prepare internal systems deviations reports and support the implementation of corrective and preventative actions Ensure all clinical research databases are up to date e.g. ClinicalTrials.gov or Eudract. Attend all relevant Trial Management Group/Trial Steering Committees. Support the Head of Research Governance, Quality and Integrity in preparing sponsor research metrics. Support research teams in the preparation of APRs and DSURs and ensure that they are submitted to the regulatory authorities within the timelines Support the preparation of end of study reports and ensure that they are submitted to the regulatory authorities within the timelines. Support research teams during study close out Ensure all Investigator Site Files and Trial Master Files are archived according to requirements in conjunction with the QA manager/archivist. Work with the R&I Divisional Team to maintain up-to-date records of performance data and escalate any performance issues to senior R&I management.
Job description
Job responsibilities
SPONSORSHIP APPLICATIONS AND APPROVALS Act as the sponsor point of contact within NUH and for outside organisations. Work closely with the Divisional R&I teams to ensure that the required sponsorship research milestones are identified and costed for during the grant application process. Review medical device Technical Files to ensure all regulatory essential requirements are met. Review sponsorship requests in accordance with NUH policy, with the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP) and appropriate Clinical Trials/medical device Regulations. Engage with other teams within R&I, NUH and other organisations to ensure the feasibility of the study. Perform study feasibilities, risk assessments and complete Schedule of Events for NUH sponsored studies. Support research teams to assess capacity and capability to deliver the proposed NUH sponsored study at NUH. Liaise with the R&I Research Contracts team to ensure the legal requirements of the study are met and that appropriate contracts and insurance are in place prior to research commencing at any site. Ensure all study vendors are reviewed in accordance with Vendor Management process. Work with study teams to develop documentation required for the study and support the researcher during the submission to the relevant approval bodies via IRAS. Support and facilitate queries from relevant approval bodies. Ensure sponsorship data is captured in Documas. Effectively disseminate information on research governance procedures to all staff, independent contractors, researchers, service users, carers and members of the public. Work within Trust-wide policies and procedures relating to Research and Research management where appropriate, working to ensure that documents are prepared to a high standard and delivered on time.STUDY SPONSORSHIP MANAGEMENT Work with R&I finance to ensure all research study budgets, costs and funding sources are appopriately managed and a clear audit trail maintained. Support research-related financial management in NUH. This includes working with the R&IDivisional Team to maintain appropriate financial systems to support research and R&I income where required. Maintain sponsor files and Trial Master Files (electronic and hard copy) in accordance with GCP essential requirements. Support the research teams in identifying and resolving barriers for the delivery of NUH sponsored research projects and escalating issues as appropriate. Support the management and set-up of multi-site studies (where appropriate) by working with the CI and their team and liaising with other site investigators. Co-ordinate and facilitate Site Initiation visits for NUH sponsored research. Ensure all queries and issues are addressed prior to issuing C&C/greenlight. Prepare and implement a risk based and robust monitoring plan for studies sponsored by NUH. Act as a clinical trials monitor, by conducting ongoing monitoring visits for NUH sponsored studies according to their monitoring plan, where applicable. Support and facilitate the close out of monitoring queries. Facilitate GCP and R&I SOP training. Ensure training records for research teams are up to date. Act as R&I pharmacovigilance facilitator for CTIMPs by ensuring:o SAE reports are processed and sent to medical monitor, all follow- up reports are processed and reviewed by the medical monitor. All SAEs are reconciled on a regular basis. If required, ensure SUSARs are reported to the MHRA within the timelines. Support the study team in preparing amendments, ensure all study amendments are reviewed and classified correctly i.e. minor or substantial. Support the submission of amendments to the relevant approval body. And address queries from the relevant approval bodies. Review and approve all protocol deviations, violations and breaches. Report violations and breaches to the relevant approval bodies. Support the research team to investigate root causes and implementation of corrective and preventative actions. Prepare internal systems deviations reports and support the implementation of corrective and preventative actions Ensure all clinical research databases are up to date e.g. ClinicalTrials.gov or Eudract. Attend all relevant Trial Management Group/Trial Steering Committees. Support the Head of Research Governance, Quality and Integrity in preparing sponsor research metrics. Support research teams in the preparation of APRs and DSURs and ensure that they are submitted to the regulatory authorities within the timelines Support the preparation of end of study reports and ensure that they are submitted to the regulatory authorities within the timelines. Support research teams during study close out Ensure all Investigator Site Files and Trial Master Files are archived according to requirements in conjunction with the QA manager/archivist. Work with the R&I Divisional Team to maintain up-to-date records of performance data and escalate any performance issues to senior R&I management.
Person Specification
Training and Qualifications
Essential
- Educated to degree level or equivalent
- Evidence of Continuous Personal Development
- Specialist Knowledge acquired through experience
Desirable
- Up to date ICH-GCP training
Experience
Essential
- Experience of working in a research/clinical environment
- Experience of data management working with databases and using reporting tools
- Experience of producing and delivering presentations to a high standard
- Experience of training others in form of power point presentations
- Specialist knowledge of the regulatory framework around research
Desirable
- Experience of delivering training to researchers
- Project Management experience
Communication and Relationship Skills
Essential
- An understanding of the importance of maintaining security and confidentiality of information
- Ability to communicate complex information orally and in writing to a range of audiences
- Ability to deliver feedback in a positive, constructive manner
- Ability to deal with challenging behaviour from researchers in a calm, diplomatic and professional manner
- Ability to build excellent working relationships and gain the respect and confidence of others
- Excellent team player
Desirable
- An understanding of audits and inspections of research studies
- Experience in conducting monitoring procedures for research studies
- Financial/contractual management
Analytical and Judgment Skills
Essential
- Ability to read, digest and interpret complex documents
- Ability to accurately interpret and present complex data in appropriate formats
- Ability to process specialist and complex information
- Ability to learn new information, procedures and processes in a limited time period
- Good problem solving skills with the ability to make well informed decisions on a continuous basis
Commitment to Trust Values and Behaviours
Essential
- oMust be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards
Person Specification
Training and Qualifications
Essential
- Educated to degree level or equivalent
- Evidence of Continuous Personal Development
- Specialist Knowledge acquired through experience
Desirable
- Up to date ICH-GCP training
Experience
Essential
- Experience of working in a research/clinical environment
- Experience of data management working with databases and using reporting tools
- Experience of producing and delivering presentations to a high standard
- Experience of training others in form of power point presentations
- Specialist knowledge of the regulatory framework around research
Desirable
- Experience of delivering training to researchers
- Project Management experience
Communication and Relationship Skills
Essential
- An understanding of the importance of maintaining security and confidentiality of information
- Ability to communicate complex information orally and in writing to a range of audiences
- Ability to deliver feedback in a positive, constructive manner
- Ability to deal with challenging behaviour from researchers in a calm, diplomatic and professional manner
- Ability to build excellent working relationships and gain the respect and confidence of others
- Excellent team player
Desirable
- An understanding of audits and inspections of research studies
- Experience in conducting monitoring procedures for research studies
- Financial/contractual management
Analytical and Judgment Skills
Essential
- Ability to read, digest and interpret complex documents
- Ability to accurately interpret and present complex data in appropriate formats
- Ability to process specialist and complex information
- Ability to learn new information, procedures and processes in a limited time period
- Good problem solving skills with the ability to make well informed decisions on a continuous basis
Commitment to Trust Values and Behaviours
Essential
- oMust be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards
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).