R&d Project Amendments Officer

An exciting opportunity has arisen for a motivated, enthusiastic individual to join the Research & Development Directorate. We are looking to appoint a Project Amendments Officer to join a well-established team that are at the forefront of providing alternative treatment plans to the standard care pathway for patients. The post holder will play a vital part in ensuring co-ordinating the Amendments Service ensuring amendments to the research studies are processed in accordance with the identified timelines.

An awareness of the HRA (Health Research Authority) Assess, Arrange and Confirm (AAC) process and working knowledge of the Amendments Process would be advantageous.

The Post holder will provide comprehensive service support to the Researchers both internal and external to the Trust, Sponsors, R&D Senior Project Co-ordinator and R&D Management team through effective administration, co-ordination, and communication for research project amendments. They will be required to demonstrate a variety of administrative and adaptable skills through experience and have excellent interpersonal skills to effectively communicate with external collaborators, researchers, and multi-disciplinary staff across the Trust, whilst proactively promoting research within the Trust. They will work on their own initiative facilitating and undertaking R&D processes as part of the capacity and capability assessment for research amendments, seeking guidance from appropriately from Senior/Project coordinators as required for complex amendments. The post holder will be required to have a working knowledge and understanding of ICH GCP, the Research Governance Framework within the NHS, HRA processes and any other applicable European Directives.

The Royal Wolverhampton NHS Trust is one of the largest NHS trusts in the West Midlands providing primary, acute and community services and we are incredibly proud of the diversity of both our staff and the communities we serve. We are building a workforce that can help us to fulfil our values, improve quality of care for patients, and solve the health care problems of tomorrow. We’re passionate about the value that diversity of thinking and lived experience brings in enabling us to become a learning organisation and leader in delivering compassionate care for our patients.

We are delighted that we have been rated as “Good” by CQC. We have achieved numerous awards; The Nursing Times Best Diversity and Inclusion Practice and Best UK Employer of the Year for Nursing Staff in 2020.

The Trust is a supportive working environment committed to creating flexible working arrangements that suit your needs and as such will consider all requests from applicants who wish to work flexibly.
- To work on own initiative and manage own workload to ensure that R&D Directorate, Trust and regional KPIs and targets are achieved and met, and research amendments are processed through the R&D capacity and capability assessment process in a timely manner.
- Be responsible for keeping research project files and electronic systems consistent and up to date.
- Provide regular reports on amendment activity for the R&D managers as requested.
- To provide data to various internal and national databases through Microsoft and web-based programmes to generate pre-existing local reports (e.g. NIHR, HRA reporting requirements)
- Be responsible for overseeing completion of documentation and requesting further documents if necessary for R&D Project files related to the amendment.
- Undertake and record specific checks in line with national and local standards for confirmation of capability and capacity of research project amendments.
- To ensure research project amendments adhere to research governance requirements, including sponsorship issues, compliance with the Ethics process, data protection, information governance and the Human Tissue Act.
- Identify potential information governance concerns, using the risk assessment form, discussing the outcome with the sponsor where required and highlighting any issues with R&D Directorate Manager/Deputy Manager
- Extracting information from the project documentation regarding data protection, good clinical practice, consent issues, legal and ethical requirements, and any potential risks to the Trust for undertaking the research.
- Liaising with the PI and/ or research team in processing amendments.
- To inform the CI/PI where there are problems or delays in adhering to targets or issues that will impact on research project delivery.
- Review the research project documentation and obtain information on standard practice and/or extra requirements for the project amendment from the PI and/or research team if needed.

Liaise with Trust clinical and non-clinical departments to obtain NHS costs for staff, facilities, procedures, and other resources related to the proposed change to the research project/activity.
- Liaise with collaborators to obtain non-NHS costs for staff, facilities, pro