Clinical Associate Research Practitioner, ITU

Job summary

We are seeking an experience clinical associate research practitioner to join Research and Innovation department at University Hospitals of Leicester NHS Trust as an ITU clinical associate research practitioner at Glenfield hospital as part of the NIHR Biomedical Research Centre - Respiratory and infection Theme.

The post holder will work alongside Principle Investigators and support the ITU research team to provide the highest standards of patient care in line with research protocols and will ensure that such research, safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines for research and UHL policies on data protection, confidentiality and security.

The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.

Previous Applicants need not apply

Main duties of the job

Research Trial Set Up and Initiation

Collection of patient data from medical notes and completion of case record forms (CRF's) and to liaise with clinical trial co-ordinators, research nurses and investigators to ensure accurate data collection

Organise and prepare for visits by trial monitors as required by the study protocol

To evaluate patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocols.

To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate ( informed consent)

Attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects

Where appropriate, to take consent from patients/participants to enter research studies

To take relevant patient samples for clinical trials; such as blood samples, to centrifuge and separate serum, package and dispatch as per defined protocols, where appropriate

About us

Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030).

We have four primary goals:

high-quality care for all, being a great place to work, partnerships for impact, and research and education excellence

And we will embed health equality in all we do - taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities.

Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all:

we are compassionate, we are proud, we are inclusive, and we are one team

This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve.

About the University Hospitals of Leicester NHS Trust:

Job description

Job responsibilities

Assist with the acquisition and distribution of relevant trial documentation/equipment.

Provide assistance in the preparation and submission of documentation for Ethical Approval and the NIHR CSP and EDGE process

To establish trial site files for each trial in accordance with ICH-GCP and research governance.

To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol

Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation

Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries

Have a solid understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance

Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes

Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner

To ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist teams

To record and report any adverse and serious adverse events according to trial protocol and local procedure.

Contribute to effective communications within the CRN East Midlands, including preparation and delivery of regular presentations and reports.

Establish and maintain effective working relationships with all relevant organisations and individuals, including member NHS Trusts, other NIHR Clinical research networks and other providers of NHS services within the CRN, Clinical Trials Units, Industry, and NHS commissioners

As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge

Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Manager. Participates in the development of an agreed personal development plan to meet identified needs.

Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to.

Participate in the implementation of research practice standards.

Responsible for remaining adequately informed of clinical trials, R&I activity and theTrust by attendance at team brief and using other appropriate forms of communication.

To undertake mandatory training as required by the individual Trusts and additional clinical, research and IT training as required by the research studies

Work to SOPs, applicable regulatory requirements and laws as per required and

Manages a personal caseload of clinical trials and patients independently with minimal supervision/mentoring from Principle Investigators/senior research nurses/team leaders

To ensure relevant approvals are in place prior to commencing each trial

To ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines

To act as one of the primary points of contact for clinical trials patients/ parents

To educate other staff as to the responsibilities of the role and function of the research team and disseminate information on specific studies

Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly

Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance

Provides education and support for patients in research trials

Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial.

Work with the Ethics and Governance team to ensure all clinical trial documentation has appropriate ethical committee and Trust approval providing feedback to the lead clinician and research directorate.

Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities

Provide on-going audit reports as required by the trial protocols and Research & Innovation department/ethics committee

Responsible for resolving data queries raised by sponsoring organisations

Demonstrates commitment to the role of patient advocate for patients and families considering or participating in clinical trials

To provide mentorship and supervision for other research professionals and staff within and outside the department

Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved

Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement

Act as a role model for excellence in research

Management and co-ordination of specified trials and take responsibility for :

Organisation of any necessary tests and investigations as detailed within the protocol

Sample preparation ( blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.

Maintaining logs of stored samples and freezer temperatures

Maintaining adequate stock levels of sample kits

Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice

Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments.

Resolving data queries raised by sponsoring organisations

Archiving all study related material including patients notes after study closure

Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office

Tracking Serious Unexpected Event reporting

Maintaining and updating study specific site files

Notifying General Practitioners of their patients involvement in a clinical trial

please see job description/person specification for full details on the role.

Person Specification

Training and Qualifications

Essential

Minimum Grade C or above GCSE/Equivalent to include English and Maths Evidence of on-going professional development

Experience

Essential

Experience in acute care/ITU/Theatres specialty or experience of the clinical care of patients enrolled in research studies

Skills

Essential

Clinical skills including vital signs monitoring

Desirable

Extended clinical skills such as Venepuncture, cannulation, spirometry or other bespoke research assessments

Analytical and Judgement skills

Essential

Good IT Skills, particularly in the use of Web applications and MS Office /database skills

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