Job Description
The R&D department at SWLTG is looking to recruit an enthusiastic Research Assistant to work under the supervision of the R&D Governance and Clinical Trials Manager. The Research Assistant will be responsible for supporting an NIHR funded trial ‘Acceptant and Commitment Therapy (ACT) for the treatment of Functional Cognitive Disorder (FCD)’.
The successful candidate will assist the Trial Manager in delivering high quality administrative and study management, including day to day management, coordination and delivery of the trial. This is an excellent development opportunity for someone interested in trial management, to work as part of a dynamic, passionate team. Personal professional development through training, educational meetings and career guidance will also be available.
We are committed to get the very best out of our staff and support staff in their career aspirations. We have career pathways available, where you will be able to develop your skills and build on your experience to progress into other roles across different specialties. For this role, we offer career pathways in R&D Governance and Delivery. In addition, we offer ongoing training and development in all aspects of the research development and delivery pathway.
The post will be based in the R&D Office located at Springfield University Hospital, and the Clinical Research Unit (CRU) located at Barnes Hospital.
The Post holder will assist with the execution and coordination of single site National Institute of Health Research (NIHR) clinical research studies to the highest ethical, scientific and regulatory standards, and will ensure that the studies are managed in line with the research governance policies, requirements of the Sponsor and research funders, within the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP) guidelines, General Data Protection Principles (GDPR 2018), and local Standard Operating Procedures (SOPs). The Clinical Trials Manager will work closely with a multi-disciplinary team including Chief Investigators, Principal Investigators, research delivery staff, statisticians, and research and development staff at SWLSTG and external staff based at St George’s University London (SGUL)
Agile and flexible working:
As one of the few Trusts in London we are proud to offer flexible working as part of our new ways of working, and we are happy to talk flexible working at the interview stage. In this role you will be able to work Monday to Friday in the time frames from 8am to 6pm, giving you the very best of good work life balance.
We are Proud to Belong at South West London and St George’s Mental Health NHS Trust.
We have expert services, a rich history and a clear commitment to providing the best quality care for those with mental ill-health. The Care Quality Commission already rates our services as ‘good’ - we aspire to be ‘outstanding’.
This is a great time to join us. We are transforming the way we care for our communities to support our mission of Making Life Better Together. We have built two brand new mental health facilities at Springfield University Hospital, which are amongst the best in the world. More developments are planned across our sites and services.
We are inclusive and diverse and strive to be actively anti racist. We want to attract people from all backgrounds and experiences to enrich the work we do together. We are proud to co-produce and involve our local communities in all that we do.
We offer flexible working, career development and a variety of benefits to enable a positive, welcoming environment in which our people and their careers can thrive.
About our locations:
Springfield University Hospital, Tooting
Our largest, 19-ward site is in Springfield Village, created following our £150m investment into two new world class mental health facilities. A 32-acre public park, shops and cafes are coming soon. Close to shops, cafes and Tooting Bec on the Northern Line plus Earlsfield and Tooting rail stations and bus routes.
1. Trial Management Support
- Assist the Trial Manager when needed with the preparation of grant applications and development of protocols and study related materials required to conduct research e.g. Patient Information Sheets, Case Report Forms, Trial Master Site File and Site Files.
- Assist with the development and writing of trial specific procedures including development of Standard Operating Procedures (SOPs) relating to the management of the studies.
- Assist with the application for Health Research Authority (HRA) and Research Ethics Committee (REC) approvals and confirmation of Capacity and Capability within local Research and Development (R&D) Offices.
- Assist with the oversight and administration of Serious Adverse Events resolving queries, logging and reconciliation of events and notification of events to the relevant committees and authorities.
- Support with the submission and preparation of amendments and annual progress/safety reports to the Health Research Authority (HRA), Research Ethics Committees (RECs) and R&D departments.
- Assist with monitoring where required, writing monitoring reports, and ensuring monitoring actions completed by study delivery teams.
- To attend R&D conferences and support with presentation of papers related to study delivery as required.
1. Trial Coordination, Delivery, and Data Management
- Assist with the co-ordination and oversight of the initiation, day to day running and closure of one or more studies.
- Work closely with clinical study teams to ensure studies are conducted in line with the protocol and all applicable regulatory requirements.
- Contribute to the development of all study documentation, under the guidance of the CI, Trial Management Group, and Trial Manager.
- Assist with the development and/or review other essential clinical research documents including patient information sheets/letters, informed consent forms as well as regulatory paperwork ensuring compliance with relevant SOPs, legislative requirements and guidelines in accordance to SWLSTG Policies and Procedures and Good Clinical Practice.
- Assist with the development of essential study manuals, and trackers including communications tools for the trial , e.g. drafting website content and progress reports.
- Support the data management of various studies.
- Assist with data validation, producing reports and ensuring data is ready for analysis, in line with the study statisticians.
- Take part in site initiation visits.
- Assist with the set up and maintenance of Trial Master Files, and Investigator Site Files.
- Assist the Trial Manager, Chief Investigator and Statistician in writing the study related publication and final report.
- To provide administration of clinical research throughout the project life cycle, from study set-up, initiation through to closure and archiving.
- To assist delivery staff, where required, to ensure that trial protocols are adhered to by all members of the multi-disciplinary team, ensuring follow up appointments and tests required are ordered and arranged.
1. Administration
- Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
- Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
- To extract clinical information from case notes, to receive clinical and scientific information from research collaborators and to input data accurately into the online database and research files. This includes the appropriate handling and transmission of encrypted and personal data.
- Develop and maintain effective paper and electronic filing systems.
- Undertake clerical/secretarial tasks as required by the research team.
- Provide cross cover for other CRU research projects where required.
- Organise and book travel and accommodation if required associated with research studies within area of responsibility.
- Check and authorise patient expenses in connection with their clinical trial participation.
- Sourcing and ordering from appropriate research budgets and distribution of clinical supplies, stationery and equipment.
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