Research Nurse/Clinical Trial Practitioner

The Research Nurse/Clinical Trials Practitioner is an autonomous specialist working within the multi-disciplinary team. The post holder will take responsibility for the co-ordination and management of a clinical research portfolio comprising of in-house, national and international phase II and III clinical trials in haematology malignancies.

Responsibilities will include education of patients and colleagues, coordination of care of patients on trials, collection and preparation of biological samples, collection of trial data and monitoring of the expected and unexpected side effects of drugs and other treatment modalities. The post holder will be expected to develop specialized skills and knowledge relating to the conduct of clinical trials, the therapies and the relevant disease sites. The post holder will be expected to have sufficient skills to enable patients to make informed choices concerning their involvement in clinical trials by providing advice and information and acting as the patient’s advocate.

The post is clinically based to support research in all haematological malignancies, and post holders will be expected to provide cross cover for members of the team.

If you would like further information or to arrange an informal visit then please contact Dorothy Marino via email atdorothy.marino@nhs.net.

• Coordinates and conducts in-house, commercial and non-commercial national and international phase I, II and III clinical trials.
• Involved in submitting new clinical trials for ethics and Research and Development approval.
• Creates and maintains trial site files.
• Creates and maintains files of current protocols and patient information sheets/consent forms in the appropriate clinics and departments.
• Be accountable for the documentation of trial data according to ICH GCP guidelines.
• Applies critical appraisal skills in evaluating research protocols.
• Assists in the development and maintenance of databases as appropriate.
• Functions in a collaborative practice role within the multidisciplinary health care team to provide expertise in the assessment, planning, implementation and evaluation of clinical research protocols.
• Consults with primary investigators, research organisations and industry in the development and delivery of research protocols.
• Develops knowledge of the preclinical data and the specific rationale for testing an investigational agent/modality in humans.
• Ensures trial case report forms are completed in conformance with ICH GCP guidelines and within appropriate time guidelines.

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population.

We provide academically-led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas.

Our vision is to deliver top-quality patient care, excellent education and world-class research. We provide first-class acute and specialist services across eight sites:

University College Hospital (incorporating the Elizabeth Garrett Anderson Wing) National Hospital for Neurology and Neurosurgery

Royal National Throat, Nose and Ear Hospital Eastman Dental Hospital

Royal London Hospital for Integrated Medicine University College Hospital Macmillan Cancer Centre The Hospital for Tropical Diseases

University College Hospitals at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women’s health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

For more information, please access the following link: https://www.uclh.nhs.uk/

• Demonstrates autonomy as well as the ability to collaborate within a multidisciplinary healthcare team in identifying and meeting the needs of the patient and his/her family during various stages of the healthcare continuum.
• Coordinates and monitors the care of patients on clinical trials as follows:
• Participates in identifying potential patients for trials.
• Evaluates eligibility of potential patients.
• Ensures all pre-study tests are undertaken and results obtained.
• Acts as patient advocate and assists in obtaining informed consent in the first instance and as the trial progresses/unfolds.
• Registers/randomises patients onto study protocols.
• Provides general written and verbal information to patients and families on the concept of clinical trials and detailed education regarding the objectives, scientific rationale, treatment and investigations, side effects, self-care and follow-up for specific clinical trials.
• Participates in decisions concerning the treatment of patients on trials in accordance with the protocol.
• Where appropriate provides direct patient care within the expanded role of clinical trials (e.g. advanced history taking, toxicity and response evaluation skills, administration of experimental agents, etc).
• Systematically documents patient information in the medical notes.
• Schedules follow-up appointments, consistent with protocol guidelines.
• Collects and prepares biological samples as per protocol.

Maintains measurable standards of nursing care for specific care needs for patients on clinical trials