Assistant Research Administrator
5 months ago
University Hospitals Plymouth NHS Trust is looking for people with a keen interest in data to join our busy Research & Development Team based at Derriford Hospital.
Research has been at the forefront of the Covid-19 pandemic and as a consequence we are looking to expand our data management team. Your duties would involve data management and general administrative work to support the work of our busy clinical delivery team.
Looking for a new challenge, a career in research and to be part of a growing team then this could be the opportunity you are looking for. You will be fully supported with training from our experienced research team.
The post holder will work as part of the clinical research team to support the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.
The post-holder will work with the research team to provide data management, administrative and clerical support for research study delivery across an extensive portfolio of clinical trials.
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure.
**Preference will be given to internal Trust staff, as well as ‘Priority’ and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.**
Assist the clinical research team in co-ordinating a portfolio of studies.
Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
With support, have an understanding of the study set up process including:
- Assist in completing Expression of interest / study selection documents
- Liaise with the study sponsor and research team to gather all relevant study information
- Prepare submissions for local research and development approval
- Coordinate site initiation meetings
- Set up the local site file and any relevant databases and documents for the study
**Take a leading role in on-going study coordination including**:
- Conduct regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements
- Maintain effective communication between the study sponsor and the clinical research team
- Support local implementation of study amendments
- Update quality systems to record study information and enrolled patients details
- Coordinate study monitoring visits
- Support the research team with data queries and reporting as required
- Consistently demonstrate the ability to work accurately
- Conducting investigator site file checklists when required
**Take a leading role in study close out procedures including**:
- Liaise with the sponsor for final monitoring visit
- Liaise with R&D regarding study close out and archiving
- Assist with data management according to study complexity and ensure that data is transcribed accurately where required
- Support internal audit and monitoring
- Support appropriate studies within PHNT/UHP
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