Clinical Trials Monitor

Hull University Teaching Hospitals NHS Trust

Information:

This job is now closed

Job summary

The Research, Development and Innovation team are inviting applications for the post of Clinical Trials Monitor.

The post holder will implement and deliver a monitoring programme to ensure that all HUTH and NLaG Trust sponsored clinical trials - including those with investigational medicinal products (IMPs) are conducted according to UK legislative requirements, Good Clinical Practice and the UK Policy Framework for Health and Social Care Research.

The successful applicant will be highly motivated with a proactive approach to managing their own workload, with excellent communication andleadership skills and qualified to masters or higher degree level or equivalent experience. The post holder will have experience of clinical researchin the NHS. You should also have knowledge of GCP and current UK clinical trials legislation.

Main duties of the job

The post holder will be responsible for conducting GCP monitoring for HUTH and NLaG-sponsored trials and for some research studiessponsored by other non-commercial organisations being undertaken within the two organisations.

The post holder will support the risk assessment of trials to determine monitoring priorities as well as organising, preparing andconducting reporting and follow-up monitoring visits according to the GCP monitoring standard operating procedure.

You will be required toescalate issues of non-compliance to the QA and RDI Manager as appropriate following SOPs and monitoring visit report forms.

About us

The Humber Health Partnership is one of the largest acute and community Partnership arrangements in the NHS, seeing well over one million patients every year and managing a budget of over £1.3 billion.

Made up of two Trusts - Northern Lincolnshire and Goole NHS Foundation Trust (NLAG) and Hull University Teaching Hospitals NHS Trust (HUTH) - our Partnership has significant ambitions and is committed to delivering world-class hospital and community services for the 1.65 million people we serve.

Together we employ nearly 20,000 staff. Our five main hospital sites are Diana, Princess of Wales Hospital, Scunthorpe General Hospital and Goole and District Hospital, for NLAG and Hull Royal Infirmary and Castle Hill Hospital for HUTH.

As Teaching Hospitals working with the Hull York Medical School, we both lead and contribute to research in many areas - biomedical research, primary care, palliative medicine, cardiovascular and respiratory medicine, vascular surgery, cancer surgery and oncology.

We believe that by developing a diverse, inclusive, innovative, skilled and caring workforce, we can deliver excellent care to our patients and a great future for our employees, our Partnership and our community.

Date posted

19 September 2024

Pay scheme

Agenda for change

Band

Band 6

Salary

£37,338 to £44,962 a year per annum pro rata

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

356-24-6522371

Job locations

CHH

Office 12, Daisy Building

Hull

HU16 5JQ


Job description

Job responsibilities

The post holder will be responsible for conducting GCP monitoring for HUTH and NLaG-sponsored trials and for some research studiessponsored by other non-commercial organisations being undertaken within the two organisations.

See Job Description and Person Specification for further details.

Job description

Job responsibilities

The post holder will be responsible for conducting GCP monitoring for HUTH and NLaG-sponsored trials and for some research studiessponsored by other non-commercial organisations being undertaken within the two organisations.

See Job Description and Person Specification for further details.

Person Specification

Qualifications

Essential

  • A masters or higher degree or equivalent experience or training to master's level equivalent

Experience

Essential

  • More than 3 year's relevant experience in the NHS or appropriate external healthcare organisation.
  • At least 2 year's researchrelated experience.

Desirable

  • Project Management

Knowledge

Essential

  • In depth knowledge of The UK Policy Framework for Health and Social Care Research.
  • In depth knowledge of EU Directives 2001/20/EC & 2005/28/EC - The Medicines for Human Use (Clinical Trials) Regulations

Desirable

  • NHS Policies and organisational structures.

Personal Attributes

Essential

  • Able to understand and explain complex issues.
  • Able to communicate effectively at all levels.
Person Specification

Qualifications

Essential

  • A masters or higher degree or equivalent experience or training to master's level equivalent

Experience

Essential

  • More than 3 year's relevant experience in the NHS or appropriate external healthcare organisation.
  • At least 2 year's researchrelated experience.

Desirable

  • Project Management

Knowledge

Essential

  • In depth knowledge of The UK Policy Framework for Health and Social Care Research.
  • In depth knowledge of EU Directives 2001/20/EC & 2005/28/EC - The Medicines for Human Use (Clinical Trials) Regulations

Desirable

  • NHS Policies and organisational structures.

Personal Attributes

Essential

  • Able to understand and explain complex issues.
  • Able to communicate effectively at all levels.

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

Hull University Teaching Hospitals NHS Trust

Address

CHH

Office 12, Daisy Building

Hull

HU16 5JQ


Employer's website

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

Employer details

Employer name

Hull University Teaching Hospitals NHS Trust

Address

CHH

Office 12, Daisy Building

Hull

HU16 5JQ


Employer's website

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

For questions about the job, contact:

Quality Assurance Manager

Leanne Cox

leanne.cox@nhs.net

01482461903

Date posted

19 September 2024

Pay scheme

Agenda for change

Band

Band 6

Salary

£37,338 to £44,962 a year per annum pro rata

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

356-24-6522371

Job locations

CHH

Office 12, Daisy Building

Hull

HU16 5JQ


Supporting documents

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