Clinical Trials Assistant (Band 4) - Research - The Royal Wolverhampton NHS Trust

The Clinical Trials Assistant (CTA) role is a vital function for the successful delivery of clinical trials. CTA\’s work directly with our R&D clinical team, comprising of clinical research practitioners, research nurses and senior research nurses – in addition to clinicians, AHP\’s and support services across the Trust.

The role involves:

• Aspects of patient care
• Clinical trial administration
• Data entry on numerous bespoke systems
• Data presentation
• Trial co-ordination
• This list is not exhaustive

This is a fluid role that will cover a varied portfolio, based on service needs. This may include:

• Cardiovascular
• Haematology
• Oncology
• Orthopaedics
• Paediatrics
• Renal
• Respiratory
• This list is not exhaustive

Main duties of the job

Whilst we embrace innovation and new ways of working, the use of AI tools in completing applications is monitored to ensure transparency and fairness.

You are permitted to use AI to assist with your application; however, you are required to declare its use. This allows us to understand how AI is being utilised and to maintain an equitable review process. Failure to disclose the use of AI tools may result in disqualification or further investigation into your application.

CTA\’s are a key contact for trial monitors for all active studies. They will assist in the set-up of clinical trials on site, liaising with the trial center and other relevant staff to organise the site initiation visit.

CTA\’s will provide high-quality administration in all aspects relating to the study, including:

• Assist in the preparation of documentation when submitting trial protocols and paperwork to various committees and regulatory agencies for review and approval (ethics and Research and Development etc)
• Request patient notes for screening purposes
• Identify patients suitable for entry into clinical trials by screening notes and attending Multi-Disciplinary Team meetings and clinics
• Forward trial data promptly to the trial co-ordinating centre and liaise with their personnel as necessary.
• Ensure that clinical trial databases and logs are maintained
• Plan, prepare and participate in monitoring visits and respond to trial data queries

Working for our organisation

The Royal Wolverhampton NHS Trust is one of the largest NHS trusts in the West Midlands providing primary, acute and community services and we are incredibly proud of the diversity of both our staff and the communities we serve. We are building a workforce that can help us to fulfil our values, improve the quality of care for patients, and solve the health care problems of tomorrow. We’re passionate about the value that diversity of thinking and lived experience brings in enabling us to become a learning organisation and leader in delivering compassionate care for our patients.

We are delighted that we have been rated as “Good” by CQC. We have achieved numerous awards; The Nursing Times Best Diversity and Inclusion Practice and Best UK Employer of the Year for Nursing Staff in 2020.

The Trust is a supportive working environment committed to creating flexible working arrangements that suit your needs and as such will consider all requests from applicants who wish to work flexibly.

Detailed job description and main responsibilities

To disseminate information to consultants regarding new trials identified on the on the National Research portal to enable optimal patient recruitment.

Assist in the preparation of documentation when submitting trial protocols and paperwork to various committees and regulatory agencies for review and approval (ethics and Research and Development etc).

Assist in the set-up of trials on site i.e. liaise with trial centre and other relevant staff to organise trial set-up visit.

Request patient notes for screening purposes.

Identify patients suitable for entry into clinical trials by screening notes and attending Multi-Disciplinary Team meetings and clinics.

Processing blood samples in accordance with specific study instructions/packaging of samples in line with biologic sample preparation guidelines.

Consenting patients into non-clinical questionnaire only.

Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required.

Liaise with Research nurse/radiographers/P.I’s to record, organise and ensure the timely administration of treatment and any necessary follow up investigations and visits.

Assist in reviewing and recording treatments, adverse events, toxicities and response to treatment. Organise the collection, storage and shipment of protocol specific samples. Explain, dispense and collect patient quality of life questionnaires and diaries. Liaise with designated Pharmacist to co-ordinate the availability and dispensing of trial drugs if required on instruction from RGN/P.I/ Radiographer.

In discussion with research nurse report adverse and serious adverse events to the relevant personnel and act as required.

In conjunction with senior research nurses maintain contact with and provide on-going information and support to the patient in a sensitive and professional manner. Refer to other specialists as required in order to provide optimal patient care.

Within a Clinical Trials Assistant capacity you would be expected to demonstrate an understanding of the implementation of Good Clinical Practice (GCP) whilst adhering to study protocols and SOP’s ensuring a safe environment for research participants. Liaise with trial centres and relevant departments in order to promote a good working environment and ensure the smooth running of clinical trials for patients.

Work at all times according to regulations described in local Standard Operating Procedures, Good Clinical Research Practice and European Directive.

Maintain adequate patient records and accurately document data collected in case report forms and nursing/medical notes.

Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary.

Ensure that clinical trial databases and logs are maintained.

Support mandatory research performance reporting to the NIHR. Collecting information from Trust project management systems and research teams in order to complete reporting templates. Submitting the above information, as stipulated by the NIHR and within strict timescales, under the direction of the R&D Directorate Manager.

Submission of the research performance information for publication on Trustnet, as per NIHR requirements.

Undertake duties as EDGE administrator for the R&D department. Responsible for checking data quality and responding to data queries, liaising with clinical and non-clinical colleagues and study sponsors to ensure complete and accurate study records are maintained on EDGE.

Support the training of staff in the use of EDGE, including the roll-out of updates to the EDGE project management system.

Confirm research recruitment activity for RWT sponsored studies in CPMS, checking with research delivery staff the number of screened/recruited/declined patients each month.

Confirm research recruitment activity with identified personnel at other sites undertaking RWT sponsored studies, ensuring information is accurate and up to date on CPMS.

Ensure the confidentiality of verbal, written and computerised information.

Will be required to complete necessary notes/research notes in preparation for patient visits.

Where appropriate assist research nurse in facilitation of research clinics.

Plan, prepare and participate in monitoring visits and respond to trial data queries.

Provide information to allow for invoice to be raised for payments where appropriate.

Attend local research meetings, induction and training programmes and any other relevant education and training days/programmes as appropriate.

To assist in demonstrating the value of research and innovation activity as part of the R&D and CRN marketing initiatives.

Provide support to other colleagues as required.

Person specification

Qualifications

• Educated to a minimum of diploma standard or equivalent

Experience

• Proficient in Microsoft Office Suite, Excel, Access and PowerPoint
• Effective organisational skills

Flexible Working – As a major employer in the Black Country and West Birmingham region we are committed to supporting all employees to achieve a healthy work life balance. We want the Black Country and West Birmingham region to be the best place to work and as such will consider all requests to work flexibly taking into account personal and individual circumstances alongside the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the Recruiting Manager as part of the on-boarding process.

Qualifications – Please be advised that if the post that you are applying for requires any level of qualification (e.g. A-Levels, Degree etc) or Professional Registration (e.g. Nursing and Midwifery Council, General Medical Council etc) you will be required to provide proof as part of the pre-employment process. By submitting your application you are giving the Trust permission to check the qualification certificates provided back to the source provider. Please note that a sample of all applicant’s qualifications will be checked with the educational institution or provider. Furthermore, a sample of all applicants’ qualifications will be checked back to the educational institution or provider to interview letters to further deter fraud.

Sponsorship – Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. As of 1 January 2021, free movement ended and the UK introduced a points-based immigration system. Further information is available regarding two types of visa; Health Care Visa https://www.gov.uk/health-care-worker-visa/your-job and Skilled worker visa https://www.gov.uk/skilled-worker-visa .

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

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