The Mid Yorkshire Teaching NHS Trust

Clinical Trials Assistant

Information:

This job is now closed

Job summary

Are you looking for a rewarding career in Research?

We are delighted to be offering a full time/part time post, to suitable candidates wishing to start or develop their skills and practice in Clinical Research. We have a team of around 54 staff including Research Nurses, AHPs research governance and Research Administrative staff, working together to ensure that research is considered as part of patient care options for all eligible patients and ensure that research opportunities are available to our patients.

Working in Clinical Research, you will join an enthusiastic, driven, and caring research team, to help provide support to our research team, for new and existing studies. Our team participates in research within many different specialities across the Trust. There are always opportunities to gain knowledge and experience within a number of these specialities. Clinical research experience is not essential for the role, full research training will be given; we have an excellent induction and ongoing education programme.

Main duties of the job

The post holder will assist with the delivery of direct and indirect clinical and research care in support of research studies within the acute care team which covers a number of areas including emergency and critical care and surgical specialities. The post holder will assist with the general administrative requirements associated with study set up, running and closing of a clinical trial including data collection, data entry maintenance of essential documents. All work undertaken in the Department, is in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP) to ensure provision of high-quality care.

The post holder will carry out assigned clinical duties under direct and indirect supervision of senior nursing staff other relevant professional practitioners to provide, through Divisional policies, a safe environment for the treatment of research subjects, and the protection of staff.

About us

We provide care and support to over a million people in Wakefield and Kirklees in their homes, community settings and across our three hospital sites at Pontefract, Dewsbury and Pinderfields (Wakefield).

Always striving for excellence, we are at the forefront of innovation and research, and we invest in teaching and the development of our workforce.

We live by our values of caring, improving, being respectful and maintaining high standards. We listen and learn because we aim to make Mid Yorkshire the best place to work and receive care.

We value diversity and welcome talent and enthusiasm irrespective of age, disability, neurodivergence, sex, gender identity and gender expression, race or ethnicity, religion or belief, sexual orientation, or other personal circumstances including providing unpaid carers support to someone with a health and care need. As ethnic minority groups, members of the LGBTQ+ community, and people with a disability/neurodivergence are currently under-represented across the organisation, we encourage applications from members of these groups. We have policies and procedures to ensure all applicants are treated fairly and consistently.

We are proud of our staff networks - who offer valuable guidance and feedback from those with lived experience.

We have a clear vision and you could be part of this! If you share our values and you want to make a difference to the lives of our patients and their families and carers, we would love to hear from you.

Details

Date posted

20 October 2023

Pay scheme

Agenda for change

Band

Band 3

Salary

£22,816 to £24,336 a year pay is pro-rated for part time positions

Contract

Permanent

Working pattern

Full-time, Part-time

Reference number

C9377-CORP0326

Job locations

Pinderfields Hospital

Aberford Road

Wakefield

West Yorkshire

WF1 4DG


Job description

Job responsibilities

  • To assist in the identification of patient eligibility for studies/trials.
  • Liaise with other appropriate health care professionals
  • To assist with the co-ordination of the patients journey through the clinical trial protocol e.g., requisition and organisation of any necessary investigations.
  • To use resources effectively by prioritising daily caseload to maximise the benefit to patients
  • To undertake clinical duties and non-clinical duties as directed by a qualified health care professional
  • To undertake frequent therapeutic handling and moving of patients with aids (as needed) and equipment utilising moderate physical effort within clinical and non-clinical settings. This may involve bending, kneeling or frequent repetitive activities often in confined spaces
  • To ensure that all members of the multidisciplinary team are aware of the current trials portfolio
  • To provide feedback to Clinical teams on issues relating to recruitment, protocol amendments and trial results
  • The post holder will demonstrate the ability to manage their own administrative caseload, working as part of the team
  • In conjunction with all members of the clinical trials team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service. To assist the research teams in the formulation of documentation in preparation for ethical submission and R&D submission
  • To assist the research team in setting up new studies/trials, ensuring site files are maintained in accordance with ICH GCP
  • To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols
  • To ensure that all quality-of-life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments
  • To ensure that all trial data is submitted to the study sponsor within the specified time constraints
  • To manage and respond to any data queries received.
  • To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs
  • To report monthly accrual data on all patients recruited into studies highlighting local activities that might impact on achievement of targets
  • To ensure all accrual data is inputted onto the recruitment database/electronic systems
  • To be responsible for monitoring and ordering specific trial equipment and stationary
  • To assist in the planning and organising study feasibility meetings and site initiation meetings, involving internal and external teams
  • To take minutes and maintain documentation during trial management meetings or other related meetings
  • To assist in the writing of standard operating procedures
  • To clearly communicate timely, accurate and relevant information regarding patient care with patients, their families and carers, other professionals and services, to ensure seamless, quality care and to empower patients to become partners in their care
  • To maintain standards in organising health information, to safeguard the confidentiality of patient information, be aware and comply with policies, practices and legislation that affect the practice of the Nursing Service. Also, to ensure accurate record keeping, file management and profiling data
  • To maintain standards in ongoing health information, both electronic and paper based, ensuring safe keeping and confidentiality accurate record keeping of relevant data and profiling
  • To participate and contribute to the development of partnership working; to positively influence the development of services, through maintaining an awareness of multi-disciplinary agencies within the community. To ensure effective seamless patient care across partner organisations
  • To monitor and maintain health and security of self and patients in the working area. To identify and report changes that may increase risk to staff, patients and carers
  • To maintain job competencies through continuous professional development and attendance on relevant courses
  • To participate in Appraisal process in accordance with the Knowledge and Skills Framework
  • To undertake all mandatory / essential training as required by the Organisation
  • To adhere to Organisational Policies, procedures and protocols to promote the highest quality of care within the patient experience
  • To travel independently between sites

Job description

Job responsibilities

  • To assist in the identification of patient eligibility for studies/trials.
  • Liaise with other appropriate health care professionals
  • To assist with the co-ordination of the patients journey through the clinical trial protocol e.g., requisition and organisation of any necessary investigations.
  • To use resources effectively by prioritising daily caseload to maximise the benefit to patients
  • To undertake clinical duties and non-clinical duties as directed by a qualified health care professional
  • To undertake frequent therapeutic handling and moving of patients with aids (as needed) and equipment utilising moderate physical effort within clinical and non-clinical settings. This may involve bending, kneeling or frequent repetitive activities often in confined spaces
  • To ensure that all members of the multidisciplinary team are aware of the current trials portfolio
  • To provide feedback to Clinical teams on issues relating to recruitment, protocol amendments and trial results
  • The post holder will demonstrate the ability to manage their own administrative caseload, working as part of the team
  • In conjunction with all members of the clinical trials team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service. To assist the research teams in the formulation of documentation in preparation for ethical submission and R&D submission
  • To assist the research team in setting up new studies/trials, ensuring site files are maintained in accordance with ICH GCP
  • To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols
  • To ensure that all quality-of-life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments
  • To ensure that all trial data is submitted to the study sponsor within the specified time constraints
  • To manage and respond to any data queries received.
  • To maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs
  • To report monthly accrual data on all patients recruited into studies highlighting local activities that might impact on achievement of targets
  • To ensure all accrual data is inputted onto the recruitment database/electronic systems
  • To be responsible for monitoring and ordering specific trial equipment and stationary
  • To assist in the planning and organising study feasibility meetings and site initiation meetings, involving internal and external teams
  • To take minutes and maintain documentation during trial management meetings or other related meetings
  • To assist in the writing of standard operating procedures
  • To clearly communicate timely, accurate and relevant information regarding patient care with patients, their families and carers, other professionals and services, to ensure seamless, quality care and to empower patients to become partners in their care
  • To maintain standards in organising health information, to safeguard the confidentiality of patient information, be aware and comply with policies, practices and legislation that affect the practice of the Nursing Service. Also, to ensure accurate record keeping, file management and profiling data
  • To maintain standards in ongoing health information, both electronic and paper based, ensuring safe keeping and confidentiality accurate record keeping of relevant data and profiling
  • To participate and contribute to the development of partnership working; to positively influence the development of services, through maintaining an awareness of multi-disciplinary agencies within the community. To ensure effective seamless patient care across partner organisations
  • To monitor and maintain health and security of self and patients in the working area. To identify and report changes that may increase risk to staff, patients and carers
  • To maintain job competencies through continuous professional development and attendance on relevant courses
  • To participate in Appraisal process in accordance with the Knowledge and Skills Framework
  • To undertake all mandatory / essential training as required by the Organisation
  • To adhere to Organisational Policies, procedures and protocols to promote the highest quality of care within the patient experience
  • To travel independently between sites

Person Specification

Experience

Essential

  • Evidence of previous administrative experience.
  • Ability to demonstrate accuracy, efficiency, and attention to detail in written documentation.
  • Ability to confidently communicate effectively within a multi-disciplinary setting.
  • Previous experience of working within a team.
  • Ability to use a variety of computer software systems.
  • Good interpersonal and communication skills.
  • Good time management skills including ability to work to set deadlines.
  • Ability to work flexibly, quickly and accurately.
  • Experience of working with patients requiring healthcare.

Desirable

  • Demonstrate knowledge and understanding of the standards contained in the research governance framework for health and social care, and ICH-GCP (Good Clinical Practice).
  • Experience of dealing with people in a health setting/environment.
  • Experience of working in a research setting.
  • Experience of working in a Health and Social Care setting.
  • Experience in the use of NHS Systems i.e E windip and EDGE etc.

Skills and Abilities

Essential

  • Able to communicate clearly and concisely over the phone and face to face with all grades of staff and members of the public.
  • Willingness to take on tasks.
  • Ability to acknowledge deficits in own knowledge.
  • Ability to work under pressure.

Personal Attributes

Essential

  • Demonstrate motivation and reliability.
  • Demonstrate ability to value others opinions.
  • Flexible with regard to work patterns and cross site working.

Qualifications

Essential

  • Educated to GCSE level in English, Maths and IT. Pass at grade C or above (or equivalent experience).
  • Willingness to undertake role specific competencies within 12 months.
  • Certificate of Good Clinical Practice training or willingness to complete within 3 months.

Desirable

  • Further education to A level in English, Maths and IT skills.

Knowledge and Awareness

Essential

  • Evidence of using ones own initiative.
  • Awareness of risks, identifying them and alerting appropriate personnel.
  • Knowledge of basic PC systems.
  • Ability to learn new skills and adapt existing knowledge.
  • Understanding of responsibility, accountability and confidentiality, relevant to the healthcare role.
  • To have a basic understanding of the NHS and the roles of nurses, therapists and social care professionals within a healthcare setting.
  • Ability to concentrate with accurate data collection and input to Case Report Files.
Person Specification

Experience

Essential

  • Evidence of previous administrative experience.
  • Ability to demonstrate accuracy, efficiency, and attention to detail in written documentation.
  • Ability to confidently communicate effectively within a multi-disciplinary setting.
  • Previous experience of working within a team.
  • Ability to use a variety of computer software systems.
  • Good interpersonal and communication skills.
  • Good time management skills including ability to work to set deadlines.
  • Ability to work flexibly, quickly and accurately.
  • Experience of working with patients requiring healthcare.

Desirable

  • Demonstrate knowledge and understanding of the standards contained in the research governance framework for health and social care, and ICH-GCP (Good Clinical Practice).
  • Experience of dealing with people in a health setting/environment.
  • Experience of working in a research setting.
  • Experience of working in a Health and Social Care setting.
  • Experience in the use of NHS Systems i.e E windip and EDGE etc.

Skills and Abilities

Essential

  • Able to communicate clearly and concisely over the phone and face to face with all grades of staff and members of the public.
  • Willingness to take on tasks.
  • Ability to acknowledge deficits in own knowledge.
  • Ability to work under pressure.

Personal Attributes

Essential

  • Demonstrate motivation and reliability.
  • Demonstrate ability to value others opinions.
  • Flexible with regard to work patterns and cross site working.

Qualifications

Essential

  • Educated to GCSE level in English, Maths and IT. Pass at grade C or above (or equivalent experience).
  • Willingness to undertake role specific competencies within 12 months.
  • Certificate of Good Clinical Practice training or willingness to complete within 3 months.

Desirable

  • Further education to A level in English, Maths and IT skills.

Knowledge and Awareness

Essential

  • Evidence of using ones own initiative.
  • Awareness of risks, identifying them and alerting appropriate personnel.
  • Knowledge of basic PC systems.
  • Ability to learn new skills and adapt existing knowledge.
  • Understanding of responsibility, accountability and confidentiality, relevant to the healthcare role.
  • To have a basic understanding of the NHS and the roles of nurses, therapists and social care professionals within a healthcare setting.
  • Ability to concentrate with accurate data collection and input to Case Report Files.

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Additional information

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

The Mid Yorkshire Teaching NHS Trust

Address

Pinderfields Hospital

Aberford Road

Wakefield

West Yorkshire

WF1 4DG


Employer's website

https://www.midyorks.nhs.uk/ (Opens in a new tab)


Employer details

Employer name

The Mid Yorkshire Teaching NHS Trust

Address

Pinderfields Hospital

Aberford Road

Wakefield

West Yorkshire

WF1 4DG


Employer's website

https://www.midyorks.nhs.uk/ (Opens in a new tab)


Employer contact details

For questions about the job, contact:

Senior Research Nurse

Alex Metcalfe

alexandra.metcalfe1@nhs.net

Details

Date posted

20 October 2023

Pay scheme

Agenda for change

Band

Band 3

Salary

£22,816 to £24,336 a year pay is pro-rated for part time positions

Contract

Permanent

Working pattern

Full-time, Part-time

Reference number

C9377-CORP0326

Job locations

Pinderfields Hospital

Aberford Road

Wakefield

West Yorkshire

WF1 4DG


Supporting documents

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