Clinical Research Practitioner

Nottingham University Hospitals NHS Trust

2mo ago

Job
Full-time
Junior, Mid & Senior Level
Research & Development
Healthcare
Nottingham

AI generated summary

You must assist in patient care, coordinate sample processing, manage trial documentation, ensure ethics compliance, and support recruitment and communication within multidisciplinary teams.
You will assist in patient care, coordinate sample processing, manage trial documentation, ensure protocol compliance, support recruitment, and maintain effective communication with multidisciplinary teams.

Requirements

ClinicalAssist research nurses/ACPs/Clinicians in delivery of patient care to research participants.
Support and co-ordinate obtaining and processing of blood and tissue samples in the clinical setting as well as optimising recruitment via clinics and MDTs.
Work alongside research nurses ensuring samples are collected and recorded per protocol.
Review and record treatments, adverse events and response to treatment to relevant studydocumentation including source data and case report forms including electronic data entry.
Plan, prepare and participate in monitoring visits and respond to trial data queries.
To function as a member of the Research and Innovation Clinical Trials Team to providededicated clinical trials support to research teams across NUH.
Working within a multidisciplinary team, to co-ordinate a caseload of patients participating in local, national and international clinical trials in various treatment types.
Ensure ethics and R&D approval and indemnities are in place before recruitment of firstpatients to a newly set up trial.
Facilitate the set-up of trials on site i.e. SSI submission via IRAS account, liaise with trial centre and other relevant staff to organise trial set-up visits.
Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required, obtain the results, ensure eligibility and randomise the patient.
Liaise with medical staff to record organise and ensure the timely administration of treatment and any necessary follow up investigations and visits.
Liaise with histopathology ensuring tissue samples are stored via Tissue Bank guidelines, organising storage and catalogue of samples kept.
To ensure effective communication with support departments to request and obtain specific trial related information. E.g. Radiology copy scans, histological status and tissue samples.
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.
Provide information to allow for invoices to be raised for payments where appropriate.
Contribute to and supply verbal and written information on the teams portfolio of trials and the number of patients recruited to the R&I team, hospital/university staff, local/Network meetings, regulatory bodies etc., as required.
Maintain patients records and accurately document data collected in case report forms and medical notes, ensuring correct storage and maintaining confidentiality.
To record trial activity on data systems and plan yearly Audits on recruitment as required by the clinicians.
Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary.
Attend local and national meetings and feedback to members of the team.
Work alongside medical and nursing staff to assist in the informed consent process by giving information to patients concerning trials and allowing them to reach a fully informed decision about participation.
To have specific and specialist knowledge of the patient pathway with regard to individual patients diagnosis and the treatment options that are available to them.
Report adverse and serious adverse events to the relevant trial centre and site personnel, within the agreed timelines to ensure trial procedures and patient safety parameters are met.
Act as a contact point for the patient and their relatives. Maintaining contact with and providing ongoing information and support to the patient in a sensitive and professional manner.
Participate in Continued professional development and undertake additional training as required per Knowledge Skills Framework and research staff competence framework.
Assist in the review of trial protocols and identify resource implications for the site.
Identify patients suitable for entry into clinical trials by attending clinics and Multi Disciplinary Team meetings.
Ensure trial protocols are adhered to and that all personnel involved in trials are aware of any changes or protocol amendments.
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 NUH Policies, procedures and Standard Operating Procedures, Good Clinical Research Practice and European Directive and R&I Standard Operation Procedures.

Responsibilities

ClinicalAssist research nurses/ACPs/Clinicians in delivery of patient care to research participants. Support and co-ordinate obtaining and processing of blood and tissue samples in the clinical setting as well as optimising recruitment via clinics and MDTs. Work alongside research nurses ensuring samples are collected and recorded per protocol. Review and record treatments, adverse events and response to treatment to relevant studydocumentation including source data and case report forms including electronic data entry. Plan, prepare and participate in monitoring visits and respond to trial data queries. To function as a member of the Research and Innovation Clinical Trials Team to providededicated clinical trials support to research teams across NUH. Working within a multidisciplinary team, to co-ordinate a caseload of patients participating in local, national andinternational clinical trials in various treatment types. Disseminate information to consultants regarding new trials on the National Institute of Health Research trial portfolio as well as non-adopted clinical trials, to enable optimal patient recruitment. Ensure ethics and R&D approval and indemnities are in place before recruitment of first patients to a newly set up trial. Facilitate the set-up of trials on site i.e. SSI submission via IRAS account, liaise with trial centre and other relevant staff to organise trial set-up visits. Liaise with clinical teams to organise and ensure that trial specific investigations are undertaken as and when required, obtain the results, ensure eligibility and randomise the patient. Liaise with medical staff to record organise and ensure the timely administration of treatment and any necessary follow up investigations and visits. Liaise with histopathology ensuring tissue samples are stored via Tissue Bank guidelines, organising storage and catalogue of samples kept. To ensure effective communication with support departments to request and obtain specific trial related information. E.g. Radiology copy scans, histological status and tissue samples. 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. Provide information to allow for invoices to be raised for payments where appropriate. Contribute to and supply verbal and written information on the teams portfolio of trials and the number of patients recruited to the R&I team, hospital/university staff, local/Network meetings, regulatory bodies etc., as required. Maintain patients records and accurately document data collected in case report forms and medical notes, ensuring correct storage and maintaining confidentiality. To record trial activity on data systems and plan yearly Audits on recruitment as required by the clinicians. Forward trial data in a timely manner to the trial co-ordinating centre and liaise with their personnel as necessary. Attend local and national meetings and feedback to members of the team. Work alongside medical and nursing staff to assist in the informed consent process by giving information to patients concerning trials and allowing them to reach a fully informed decision about participation. To have specific and specialist knowledge of the patient pathway with regard to individual patients diagnosis and the treatment options that are available to them. Report adverse and serious adverse events to the relevant trial centre and site personnel, within the agreed timelines to ensure trial proceduresand patient safety parameters are met. Act as a contact point for the patient and their relatives. Maintaining contact with and providing ongoing information and support to the patient in a sensitive and professional manner. Participate in Continued professional development and undertake additional training as required per Knowledge Skills Framework and research staff competence framework. Assist in the review of trial protocols and identify resource implications for the site. Identify patients suitable for entry into clinical trials by attending clinics and Multi Disciplinary Team meetings. Ensure trial protocols are adhered to and that all personnel involved in trials are aware of any changes or protocol amendments. 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 NUH Policies, procedures and Standard Operating Procedures, Good Clinical Research Practice and European Directive and R&I Standard Operation Procedures.

FAQs

What is the primary role of a Clinical Research Practitioner?

The primary role of a Clinical Research Practitioner is to assist research teams in delivering patient care to research participants, coordinating sample collection, ensuring protocol adherence, and facilitating clinical trial activities.

What types of clinical trials will I be involved with?

You will be involved in local, national, and international clinical trials across various treatment types.

What qualifications are required for this position?

While specific qualifications might not be listed, candidates typically require relevant healthcare or clinical research qualifications, as well as experience in clinical trials.

Is there a requirement for ongoing professional development?

Yes, participation in continued professional development and additional training as required per the Knowledge Skills Framework is expected.

How will I interact with patients during their trials?

You will assist in the informed consent process, provide patients with information regarding trials, and maintain ongoing contact to offer support and information throughout their participation.

What kind of documentation will I be responsible for?

You will be responsible for maintaining patient records, documenting data collected in case report forms and medical notes, and ensuring confidentiality and proper storage of records.

Are there opportunities for auditing and reporting on trial activity?

Yes, you will be required to record trial activity on data systems and plan yearly audits on recruitment as required by clinicians.

Will I work as part of a multidisciplinary team?

Yes, you will function as a member of the Research and Innovation Clinical Trials Team, collaborating with various healthcare professionals.

What is the importance of ethics and R&D approval in clinical trials?

Ethics and R&D approval are critical to ensure that patient safety is prioritized and that the trial adheres to regulatory standards before recruitment of the first patients.

How are samples managed during the trial?

You will organize the collection, storage, and shipment of protocol-specific samples, ensuring they are handled according to established guidelines, such as Tissue Bank guidelines.

Nottingham University Hospitals NHS Trust

We lead and support the NHS in England to deliver improved care for patients.

Science & Healthcare

Industry

10,001+

Employees

1948

Founded Year

Mission & Purpose

The NHS (National Health Service) provides comprehensive healthcare services across the United Kingdom, offering a range of medical care, from general practice to specialised treatments. Its ultimate mission is to ensure that all UK residents receive high-quality, accessible, and free healthcare at the point of use. The NHS aims to improve public health outcomes by delivering patient-centred care, advancing medical research, and promoting health and wellbeing across diverse communities. Its purpose is to offer equitable health services that support and enhance the lives of individuals, irrespective of their financial circumstances.