Senior Clinical Research Officer

As a Senior Clinical Research Officer you will have a wealth

of NHS research experience and good knowledge of the NIHRs function. You will

be responsible for supporting the operational research team with scoping new

studies, maintaining, expanding and delivering non-commercial and commercial

portfolio research.

As an experienced researcher you will be required to provide

regular supervision of Clinical Research Officers, Clinical Trials Assistants

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

youll use EDGE, Microsoft Word, EXCEL and Outlook. The role also requires an

excellent understanding of NHS clinical systems and the ability to navigate

these successfully; requesting information/data reports and engaging with our

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

challenges, families, carers and clinical teams and pharmacy is your

cornerstone to setting up and delivering successful studies.

Your ability to communicate with service users, clinical

staff and managers is also essential. There is a requirement attend and

contribute to clinical and research team meetings. In addition to setting up

and organising your own meeting schedules there will also be opportunity to

deputise meetings for the Operational Lead. The role also provides a good

opportunity to develop your leadership skills

and proficiency of the management of multiple tasks.

Your primary base will be at Fieldhead Hospital, Wakefield.

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.

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

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 host organisation for Yorkshire and Humber is Sheffield Teaching

Hospital NHS Trust. The CRN is structured into research divisions and the post

holder will work predominately on studies within the DeNDRoN, mental health

and neurology division.

A

temporary Senior Clinical Research Officer / Research Nurse (1 WTE) is required

to work with clinicians and other specialists to manage and coordinate studies

adopted onto the NIHR portfolio, these predominately being moderate to high risk Clinical Trials of

Investigational Medicinal Products or Medical Devices. 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 portfolio studies

2.

Setting up new portfolio studies

3.

Ensuring

the first patient is recruited into the study by the target date

4.

the target number of patients are recruited into the study within the

recruitment period.

5.

Increasing

the number of research active staff

6.

Management

of the clinical research officers

Travel

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

AREAS

1.

Process

Each study

will be at a different stage of the research process as detailed below. The key

tasks of each stage are outlined in A-E below:

a)

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 by

reviewing the protocol, assessing any resource implications and seeking

specialist advice where required.

Liaise with

the principal investigator and study team in order to ensure completion of

local site specific information forms and the localising of participant

documents.

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.

project feasibility and site initiation meetings, staff training and

co-ordinate any resource requirements,

e.g. room bookings and equipment.

Calculate an

achievable recruitment target for the study and set up

timelines

which will ensure the first patient can be recruited by target date.

Work with

Governance to undertake the costings for commercial research projects .

Circulate

study information and deliver study presentations to promote the research

locally.

b)

Recruitment

and screening

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.

Where

required and appropriate to do so, be responsible for the safe administration

of drugs during clinical trials.

Monitor

participants condition throughout the trial, including monitoring the expected

and unexpected side effects of drugs and other treatments administered during

clinical trials.

Keep

an accurate record of each participant screened and recruited into study

(accrual) and ensure this is correctly mapped onto the research database(s) and

communicated to the study accrual officer.

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

patient confidentiality at all times and protect the confidentiality of any

personal information.

c)

Data

collection and storage

Encourage

retention of participants throughout the study by providing ongoing

communication and support to participants and clinicians.

Complete

follow up visits either in participant homes or clinics.

Be

responsible, under the guidance of the Principal Investigator, for the

collection, anonymisation, storage, organisation and transfer of project data.

Ensure

the accuracy and completeness of data collected.

Collect

and despatch biological samples e.g. saliva or blood, that may be required for

the study, according to protocol (appropriate training can be provided).

Undertake

study specific and routine assessment e.g. vital signs, ECG, height/weight

measurements.

Administer

payments to participants, keeping accurate logs and receipts to support

accurate and timely invoicing.

and report any adverse events in accordance with the study protocol and ICH

personnel and regulatory authorities within agreed timescales.

Conduct

risk assessments as required by the study protocol/SOPs and in conjunction with

Trust reporting requirements. Ensure

prompt completion of any follow up actions, seeking guidance when required.

d)

Management

of the study

effective liaison with relevant staff, internal and external to ensure the

smooth running of the study in accordance with the latest approved protocol,

ICH-Good Clinical Practice and any study specific or R&D Standard Operating

Procedures.

Maintain

the study site file in accordance with ICH-Good Clinical Practice.

Review

the impact of any study amendments and liaise with study team to ensure the

amendment is implemented effectively.

Facilitate

and prepare for audit/monitoring visits that may be conducted by R&D staff,

study sponsor, contract research organisation or MHRA.

to ICH-Good Clinical Practice standards, the Research Governance Framework (DH

2005), national Regulatory requirements (Data Protection Act, Mental Capacity

Act, Human Tissue Act, EU Directives) and Trust policy.

effective liaison with teams within the Trust, including, Information

Governance, Medical Records, Clinical Governance, Practice Effectiveness,

Training and Development, Patient Safety and Risk and Mental Health Act Office.

Maintain accurate study costs and liaise

with finance to ensure timely and accurate invoices are raised and full study

costs are recovered.

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.

Qualifications

Desirable: - Post graduate qualification in research.

Personal Attributes

Physical Attributes

Special Knowledge/Skills

Desirable: - Knowledge of research approval process.; - Good Clinical Practice knowledge and relevant research related laws.

Experience

Essential: - Successful partnership working.; - Involvement in clinical research.

Training

Essential: - Evidence of continuous professional development.