Clinical Research Practitioner

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.

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.

• 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.
• 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.

• 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 (i.e. informed consent).
• Attend and support patients in the clinical environment for monitoring, assessment and…