Clinical Trials Assistant

The post holder will assist the Research and Innovation (R&I) team with all aspects of administration and provide high quality and efficient support in accordance with the standards set out in the UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) regulations.
Pleas note this post isn't a clinical role but you will interact with patients on the phone or welcoming them to the research unit. It will be supporting the lead research nurses on assigned studies in a non-clinical admin role.
Main duties of the job The post holder will be part of the R&I team, providing administrative support across multiple clinical specialisms, under the supervision of the Clinical Research Nursing team. They will assist in archiving study documentation at the end of research studies in line with current Trust SOPs.
About us We hold a unique position in the Stockport community as the provider of healthcare and we are one of its largest employers.
We believe that the best organisations are those that reflect the communities they serve. We are therefore seeking to improve the diversity of our workforce to make it truly representative of our local population.
We actively encourage applications irrespective of race, age, disability, sex, gender reassignment, gender identity or expression, sexual orientation, religion or belief, marriage & civil partnership, or pregnancy or maternity. Recognising those communities that are underrepresented within our workforce, we would particularly welcome applications from you.
If you require support with your application please contact a member of the recruitment team, who can discuss alternative application methods.
We recognise that flexible working is important. We take requests for flexible working seriously, consider any request we receive and try to work with you, so we can explore if your request may fit with the needs of the service.
Benefits we offer to you:
Between 27-33 days of annual leave plus bank holidays
Salary sacrifice schemes for lease cars, home electronics and more, to make your salary go further
Cycle to work scheme
Salary finance - for loans, savings, budget planning and tips on managing debt
Stockport Credit Union- for local financial advice
Job responsibilities Main Duties and ResponsibilitiesResearch and Innovation Provide general administrative support to the Trusts R&I team as directed, including the use of computerised systems (i.e. spreadsheets, databases, Microsoft Office). Work closely with the R&I office, clinical colleagues, Clinical Research Network and other external parties to help raise the profile of R&I and support achievement of performance targets. Support with all aspects of administration through study feasibility, set-up, day-to-day delivery (i.e. participant screening, follow-up aligned with protocol requirements or where sponsor defines) and closure of clinical research studies under the supervision of the Clinical Research Nurse team, in conjunction with the R&I Office. Assist representatives from sponsor organisations, regulatory authorities and/ or the R&I Office with trial monitoring visits, audit and inspection as required. Attend relevant internal and external meetings/ training sessions to develop research knowledge. Maintain up-to-date knowledge and act in accordance with research standards (e.g. International Conference on Harmonisation Good Clinical Practice [ICH-GCP], research governance and EU Clinical Trials Directives), local policies/ procedures and study protocols.
Communications Demonstrate professional and appropriate behaviour when dealing with internal and external enquiries, in adherence with the Data Protection Act and information governance. This includes verbal and other communication methods as appropriate to the situation. Liaise with internal and external NHS staff regarding case notes, data collection, biological samples, mortality data and other general trial activities, which may be confidential in nature. Attend and contribute to clinical research team meetings, network events and sponsor-led meetings. Assist with preparation of reports and presentations for the R&I Department as required. Demonstrate flexibility, enthusiasm and motivation in daily practice.
The Trust is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults and expects all staff and volunteers to share this commitment and promote safeguarding by implementing the Trusts policies and procedures, acting promptly on concerns, communicating effectively and sharing information appropriately.
If successful this vacancy will require a Standard DBS check at a cost of £26.50. This cost will be deducted from your first Trust salary.
In addition to this it will be a condition of your employment that you will join the DBS update service and pay the annual subscription fee of £16.
Person Specification Education and Qualifications Good standard of education (minimum of GCSE or equivalent, including English and Maths) and NVQ level 3 or equivalent
Knowledge Awareness of clinical trials process
Awareness of data protection/ patient confidentiality
Understanding medical terminology
Knowledge of patient information systems
Awareness of Good Clinical Practice
Experience Experience of administrative work including data management
Experience of working within clinical research/ trials administration
Experience of working within a healthcare system
Skills and Abilities Good organisational and workload management skills including ability to work to changing deadlines
Good interpersonal skills
Good oral and written communication skills
Ability to work unsupervised or as part of a team
IT literate: Good understanding and demonstrated use of Microsoft Office suite and web-based systems
Work Related Circumstances Some flexibility in working hours to meet service need
Ability to travel independently between hospital sites or to attend research related meetings (as required)
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.

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