Clinical Research Practitioner

Job summary

Would you like to be part of a busy team offering research to our patients to support the discovery of future treatments and diagnostics?

Do you have a passion for improving patient outcomes through clinical research?

Are you an individual with a clinical background, who is keen to gain experience in the field of research delivery? Or an individual currently working in an administrative research role who is keen to move into a patient facing research delivery role to progress in their career?

The role of Clinical Research Practitioner could be for you...

An exciting opportunity has arisen to be part of the Research & Innovation Team at Northampton General Hospital.

The Research & Innovation Team are a multi-disciplinary team who work in all clinical areas at Northampton General Hospital, in partnership with hospital staff, to deliver a vast array of clinical trials. This is a unique and exciting opportunity for an enthusiastic, committed and disciplined clinical research practitioner to join the team. You will be working as part of the Research & Innovation Team, supporting the delivery of a wide variety of clinical research studies.

Informal visits are strongly encouraged if you are interested in applying. We would love to show you around our Clinical Research Facility to meet our team and discover what we do.

Main duties of the job

The Research & Innovation Team at Northampton General Hospital NHS Trust leads on supporting Principal Investigators (PI's) in the setup, delivery and close out of research across all specialities within the Trust. Areas covered by the team include Rheumatology, Dermatology, Oncology, Haematology, Cardiology, Stroke, Diabetes and Women's and Child Health. The Clinical Research Practitioner will report to the Research nurse team. Research & Innovation sits within the Medical Directors Directorate.

The post-holder will support the delivery of research throughout the Trust, developing the research collaboration and maximising opportunities to increase research and innovation capacity and capability, with the aim of increasing the number of staff and patients participating in high quality research.

The Clinical Research Practitioner will be responsible for the collection, recording and maintaining of data for patients on research studies.

The post holder will support current research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.

The individual will provide clinical support to patients in clinical trials; such as taking samples, performing tests and physical measurements in accordance with the clinical trial protocol, and Good Clinical Practice.

About us

Northampton General Hospital is one of the largest employers in the area and we are on an exciting journey. All of our divisions are committed to doing things better, with more efficiency as we update, modernise, and advance. We have also entered into a Group Model with neighbouring Kettering General Hospital NHS Foundation Trust and become University Hospitals of Northamptonshire.

Our Excellence Values

Compassion

Accountability

Respect

Integrity

Courage

We want to recruit the best people to deliver our services across the University Hospitals of Northamptonshire and help to unleash everyone's full potential. As an organisation, we value how we communicate and promote our vacancies to all communities.

We are a Defence positive trust, supporting our reservists, veterans, spouses and partners.

The Hospital Group encourages applications from people who identify from all protected groups, especially those from BAME, Disabled and LGBTQ+ backgrounds as these are underrepresented in our hospitals.

We understand that we need to work with colleagues from diverse backgrounds and make sure the environment they work in is inclusive and collaborative.

We have active Networks that promote and support colleagues from all ensures everyone feels supported and has a sense of belonging working for Kettering and Northampton General Hospitals.

Job description

Job responsibilities

Research Trial Set Up and Initiation

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

Provide assistance in the preparation and submission of documentation for Regulatory review, both at site level and centrally.

To establish trial site files for each trial in accordance with ICH-GCP and UK Policy Framework for Health and Social Care Research.

Support the local set up of studies, including the implementation of amendments and close out of studies hosted at the hospital.

Responsible for data management and administrative support to research personnel who are taking part in research studies and is an integral part of the research team.

On-going Studies:

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

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 UK Policy Framework for Health and Social Care Research and conduct quality assurance of documentation.

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

Take responsibility for liaising with clinical trials units regarding data queries and for checking and resolving data queries.

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.

Clinical Practice

Have a solid understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and the UK Policy Framework for Health and Social Care Research.

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.

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

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.

Communication and Relationship Skills

Contribute to effective communications within the Trust, 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, NIHR Clinical research networks and other providers of NHS services within the CRN, Clinical Trials Units, Industry, and NHS commissioners.

Other

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 applicable to each research study, department and Trust.

Person Specification

Education, Training & Qualifications

Essential

Educated to Vocational Qualification Level 3 or equivalent level of education, training or experience Evidence of further education, study, training or experience to Diploma level Awareness of the importance of data confidentiality

Desirable

Knowledge of ICH-GCP Aware of current legislation regarding research governance issues Evidence of appropriate further education/development Research qualification ICT Qualification

Knowledge & Experience

Essential

Minimum 2 years administrative/data management experience - preferably in an NHS setting

Desirable

Experience of working within a clinical trial setting. Knowledge of research methodologies

Skills

Essential

Computer literate with Microsoft software (including word, excel and power point.) Access database handling Ability to work on own with minimal supervision Excellent communication and interpersonal skills both written and verbal Evidence of accuracy to detail in data collection Willing to undertake personal development training as required

Desirable

Sample preparation and handling Current clinical skills including phlebotomy, ECG recording, vital signs recording etc.

Key Competencies/ Personal Qualities & Attributes

Essential

Ability to work independently and as part of a small specialist team Flexible approach to working and a desire to develop knowledge Assertive and confident Demonstrates enthusiasm Professional manner

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