Job responsibilities
Background
This is a unique and exciting opportunity for an individual experienced in research to join the Research & Innovation (R&I) research delivery workforce at University Hospitals of Leicester NHS Trust.
University Hospitals of Leicester hosts the NIHR Leicester Biomedical Research Centre and the NIHR Clinical Research Facilities including the Hope Clinical Trials Facility, a centre of excellence in oncology and haematology research and the Clinical Renal Research Unit, a leading centre in national recruitment of patients in clinical trials.
All research facilities are designed to deliver clinical effectiveness, safety and a positive patient/volunteer experience in a consistent way.
JOB SUMMARY
The Research Support Officer (RSO) will work as part of the core Research and Innovation management team.
The Research Support Officer will be responsible for supporting researchers and clinical teams in the local set-up of clinical trials and all other research trials and will coordinate the process of Capacity and Capability assessment in order to receive R&I Authorisation.
Keeping abreast of legislation, the post-holder will also be responsible for implementing national best practice research management processes within the Trust. They will be responsible for ensuring that local integration of systems and processes are achieved so that individuals can benefit fully from this in a streamlined manner.
The Research Support Officer will be responsible for identifying and addressing Trust specific feasibility issues and ensuring that studies are reviewed, set up and submitted for R&I Authorisation in a timely manner.
The post-holder will be the day to day point of contact for investigators and external Sponsors and will be responsible for providing advice and support where necessary.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
INFORMATION MANAGEMENT
Ensure databases are completed accurately and maintained appropriately.
To work autonomously
Is organised and able to manage and prioritise own workload in order to meet specific deadlines.
Budget: Not applicable for role.Staff: Not applicable for role.Policy: Trust wide policies to be implemented.Communications: Good communication skills will be paramount to this position with the involvement of working across clinical business units to include physicians, MDT, research scientists, patients and carers.
KEY WORKING RELATIONSHIPS
- Key personnel within R&I such as the R&I Head of QA and Compliance, the Deputy Chief Operating Officer and the Chief Operating Officer
- Key personnel in CMGs, support services, other R&I teams such as R&I Finance, R&I Communications
- Academic Institutions
- Commercial organisations
- National regulatory authorities such as the Health Research Authority
- Other partners and collaborators such as the Clinical Research Network, Clinical Trials Units, Specialty Groups, NHS R&D Forum, NIHR, non-commercial research funders.
WORKING RELATIONSHIPSTo develop and maintain a good working relationship with multi-professional teams within the speciality.
Be responsibility for ensuring effective communication between all service providers within the speciality.Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality.
KEY RESULT AREAS
Research Management & Governance Work closely with colleagues in the Research Team to support implementation of research management processes within the Trust. Maintain a standard of conduct in accordance with trust policies Be accountable for actions and aware of limitations. Conduct financial reviews of clinical trials to ensure that they are adequately resourced. Contribute to the implementation of quality systems providing assurance to researchers that processes operate in accordance with the law, national and best practice. Support the Research Manager in providing assurances and evidence that research management processes are compliant with Governance Frameworks, relevant legislation including but not limited to the EU Directive, HRA, , REC, MHRA, ARSAC , Human Tissue Act, GTAC, CAG,MCA and the Department of Health. Provide specialist expert regulatory and governance advice and support by actively promoting the research management and governance process to deliver a smooth operation to researchers in all aspects of preparing study documentation for NHS authorisation, including but not limited to IRAS, the application process, ethics application process, finance and contracts, NHS indemnity, and highlighting where necessary requirements for Research Passports and Honorary Research Contracts. Assist researchers with applications that do not require NHS Ethics opinion or are exempt from HRA review, to ensure a smooth and streamlined approach to obtaining NHS Trust authorisation. Ensure that all projects have the necessary checks in place: e.g. HRA Approval, REC FIFO letter, MHRA, CAG, G-TAC, CMG approval, financial approval, relevant support services approvals etc. and that the required documentation is provided for review. Ensure all research applications/amendments are reviewed as appropriate in accordance with tight national deadlines, maintaining the Trusts reputation for expediency. Determine impact on Capacity and Capability and adopt a proactive approach in identifying and rectifying issues at an early stage, communicating with points of contact for individual research studies then facilitating best outcome. Signpost and highlight as appropriate when contracts are required to the Research Contracts Manager in order to ensure that all relevant contracts are in place prior to approval of a new research study or amendment at the Trust. Support the Research Manager to ensure that all research studies are and continue to be properly resourced and conducted according to applicable regulations
Information Management
-Compile and maintain the trust adopted EDGE database so that the status of studies from pre-approval to completion can be followed.
-Undertake quality assurance procedures to ensure that the data held on database systems has been checked for accuracy and completeness.
-Produce reports, as requested, to support monitoring and performance management requirements.
Communication & Relationship Skills
-Build strong working relationships with staff both internal and external who have a responsibility for R&I to ensure that they are able to comply with operating guidelines with regard to delivering research studies (portfolio and non- portfolio).
-To network at national level, with a specific focus on building new relationships with commercial business partners to support the generation of new commercial business opportunities.
-To act as the main communication between management, trials offices, R&I, partner staff (internal and external), ensuring that the latest information is disseminated accurately and quickly as directed.
-To maintain and develop communication between Principal Investigators and key researchers and be the conduit for sharing research information to inform initiatives and decisions.
-As part of the review process, communicate directly with researchers, dealing with telephone or email queries and provide one to one advice or initiate meetings, referring to agreed guidelines if necessary and using own initiative to action responses when appropriate.
-Communicate directly with staff and agencies such as Ethics committees, Universities, commercial companies, NIHR organisations, as part of review processes and to raise overall awareness.
Training & Education
-To identify areas / assessment of need for the team as a whole as well as individuals within that team.
-To develop the role of the RSO through a personal development and training programme.
-To identify needs of training relating to R&I policies and procedures across the research team, assisting management in identifying appropriate individuals to deliver training as required.
GENERAL
This job description indicates the main functions and responsibilities of the post. It is not intended to be a complete list. You may be required to undertake other duties from time to time as we may reasonably require.
You will be required to maintain compliance with all statutory and mandatory training requirements.
The link to the Trusts policies and procedures is:
https://secure.library.leicestershospitals.nhs.uk/PAGL/SitePages/Home.aspx
