Clinical Research Officer

As a Clinical Research Officer you will have successful

experience of research delivery, have a high level of motivation and organisational

skills. You will be responsible for helping with the setup of studies,

screening caseloads from our electronic clinical system, contacting patients,

families, carers and also liaising with clinical teams. You will be required to

work in and around clinical teams and

also present complex study information.

This role requires supervision of Clinical Trials Assistants

and other less experienced members of the research team. On a daily basis

youll use EDGE, Microsoft Word, EXCEL, Outlook and other software packages. Training

will be provided for requesting information/data reports and engaging with our

comms team. Your experience of working with individuals with mental and

physical health challenges is crucial to our service provision. You will be

required to arrange appointments to see service users in their own homes,

clinics or other appropriate settings.

There is a requirement to attend and contribute to research

team meetings, university and other stakeholder meetings.

The role requires you to take bloods. Phlebotomy training

will be provided.

Your primary base will be at Fieldhead Hospital, Wakefield. However,

you will be required to travel Trustwide on a regular basis. Therefore a UK

drivers licence and access to a car for business use is essential.

The NHS constitution (2009) includes a pledge to the promotion and conduct of research to improve the current and future health and care of the population.

The Research and Development Department has the principle aim of increasing quality research activity which promotes a vibrant research culture within the Trust. This is achieved through delivering and facilitating high quality research, providing support and advice on research methodologies, supporting the generation of research income through external sources and fostering collaboration with other trusts, universities, research bodies and the National Institute for Health Research (NIHR).

The NIHR is funded through the Department of Health to improve the health and wealth of the nation through research. The NIHR Clinical Research Network (CRN) is the clinical research delivery arm of the NHS and there are 15 CRNs across England. The CRN: Yorkshire and Humber is hosted by Sheffield Teaching Hospital NHS Trust. The CRN is structured into 6 research divisions covering 30 clinical specialties. The post holder will work predominantly on studies within the mental health and dementia and neurodegenerative disorders (DeNDRoN) specialities.

A temporary Clinical Research Officer (1 WTE) is required to work with clinicians and other specialists to manage and coordinate studies included in the NIHR CRN portfolio, these predominately being observational studies and some clinical trials. Adhering to Trust policies and procedures and the research protocol and ensuring support, care and safety of those involved in the trials.

Their main areas of work will focus on:

1. Assessing feasibility of potential new CRN portfolio studies

2. Setting up new CRN portfolio studies

3. Ensuring the first participant is recruited into the study within specified timescales

4. Ensuring recruitment targets are achieved within specified timescales for each study

5. Increasing the number of research active staff

For a limited period, pending full implementation of Health Research Authority Approval, the post holder will also be required to coordinate aspects of Research Governance for some studies with support from the Research Administrator and supervised by the Research and Development Manager. This will include processing studies not currently eligible for HRA approval through the existing NHS Permission process, processing study amendments and providing advice on and support for Research Governance to local clinicians and researchers.

Travel across Trust sites and occasional out of hours working will be required.

Each study will be at a different stage of the research process and specific tasks undertaken by the Clinical Research Officer will vary according to the nature of each study and as detailed in the protocol. Key tasks for each stage are outlined in 1-5 below:

1. Feasibility and study set up

Link closely with Trust services to identify opportunities for new research

Assess the feasibility of new portfolio studies with the Principle Investigator and under the supervision of the Research & Development Manager, by reviewing the protocol, assessing any resource implications and seeking specialist advice where required.

Working with the Research & Development Manager and Principle Investigator calculate an achievable recruitment target for the study and set up timelines which will ensure the first patient can be recruited by target date.

Assist the Research & Development team in undertaking the costings for commercial research projects.

In collaboration with the Research & Development Manager and Principle Investigator develop an appropriate recruitment plan to address potential recruitment barriers and to ensure patient awareness and any education needs are met, seeking advice from service users and carers in the Research Involvement Group where appropriate.

Liaise with the Research & Development team, the Principle Investigator and the study team in order to assist with the completion of local site specific information forms and the localising of participant documents.

Organise project feasibility and site initiation meetings, staff training and co-ordinate any resource requirements, e.g. room bookings and equipment.

Circulate study information and deliver study presentations to promote the research locally.

2. Recruitment and screening

Meet regularly with the local Principal Investigator and other clinicians to identify eligible participants, increase study awareness, provide study information and updates, identify any areas of low recruitment and increase recruitment.

Screen potential study participants using, for example the study inclusion and exclusion criteria and Trust clinical system RiO.

Prepare invitation letters on behalf of clinicians.

Ensure study specific investigations and screening tools are undertaken as required by the protocol to establish eligibility and safety to enter the study.

Monitor participants condition throughout the study, including monitoring of any adverse events and ensure changes to treatment as required by the protocol.

Report and record (serious) adverse events that occur whilst the participant is in the clinical trial [study] to the trial coordinator/Principle Investigator and relevant local personnel/regulatory authorities within agreed timescales.

Obtain clinical specimens (including bloods) from participants, store and package them according to the research protocol and organise their safe and timely delivery to the appropriate laboratory.

Open and maintain an accurate record of each study within the Local Portfolio Management System (currently EDGE) and maintain an accurate local record of each participant screened and recruited into the study. Ensure the data on the NIHR CRN Open Data Platform (ODP) accurately reflects the local record by maintaining close communication with the study team and report any inconsistencies to the CRN team.

Make home visits or clinic visits in order to take informed consent and complete study specific data collection. Where patients lack capacity to consent, or there is doubt around capacity, ensure appropriate liaison with clinicians and compliance with appropriate legislation and guidance.

Respect participant confidentiality at all times and protect the confidentiality of any personal information.

3. Data collection and storage

4. Management of the study

For full details of the role please see the supporting documents attached.

All employees of the Trust are

strongly encouraged to have their up-to-date flu vaccination to protect staff

and patients.

We are aware that an increasing

number of applicants are using AI technology to generate responses on NHS Job

application forms. We strongly discourage this and will conduct a thorough

screening process before selecting candidates to progress to the next stage. If

you are using AI to enhance your application, please disclose this in your application form.

are a specialist NHS Foundation Trust that provides community, mental health

and learning disability services for the people of Barnsley, Calderdale,

Kirklees and Wakefield. We also provide low and medium secure services and are

the lead for the west Yorkshire secure provider collaborative.

Our mission is

to help people reach their potential and live well in their communities, we do this

by providing high-quality care in the right place at the right time. We employ

staff in both clinical and non-clinical services who work hard to make a

difference to the lives of service users, families and carers.

We encourage

and welcome applications from all protected characteristic groups, we value

diversity and want our workforce to be reflective of our communities.

Being

a foundation Trust means were accountable to our

members, who can have a say in how were run. Around 14,300 local people

(including staff) are members of our Trust.

Join

us and you will be one of over 4,500 staff committed to supporting and improving

the mental, physical and social needs of the thousands of people we meet and

help each year.

are committed

to safeguarding and promoting the welfare of children, young people and

vulnerable adults and expects all colleagues and volunteers to share this

commitment.

We do reserve to right to close vacancy before the advertised closing date if necessary, so please apply as soon as possible.

Physical Attributes

Experience

Qualifications

Essential: - Relevant first degree level standard of education 2.1 or above or equivalent expertise by experience.

Desirable: - Post graduate qualification in relevant subject.

Special Knowledge/Skills

Training

Desirable: - Good Clinical Practice.; - Phlebotomy.

Personal Attributes