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Research Nurse/Clinical Trial Practitioner

4 months ago


London, United Kingdom University College London Hospitals NHS Foundation Trust Full time

Job summary

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 oncology and 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 oncology and haematological malignancies, and post holders will be expected to provide cross cover for members of the team.

Main duties of the job

Research

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.

About us

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 ENT and Eastman Dental Hospitals University College Hospital Grafton Way Building Royal London Hospital for Integrated Medicine University College Hospital Macmillan Cancer Centre The Hospital for Tropical Diseases University College Hospital 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.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

Job description

Job responsibilities

Clinical

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 ( 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. Communication Disseminates protocol information and research results to health care professionals by one-to-one teaching, written information and/or in-service education classes. Educates multidisciplinary team about portfolio of clinical trials. To act as a primary point of contact for patients in specific trials. Educates patient and family about clinical trials, including the objectives, scientific rationale, treatment schedule, side effects and follow up plan. Develops programs of care for patients taking part in clinical trials. Establishes and maintains links with other hospitals and GPs. Management Mentorship to data managers and clinical trial practitioners. Provides cross cover for other trial practitioners, research nurses and assistants working in the clinical trials unit as directed by the Clinical Trials Manager. If the post holder has concerns regarding standards of consent /research process in general they shall report their concerns to the Clinical Trials Manager. To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the incident, serious incidents and near misses reporting policy and procedure. Professional Adheres to Trust and Directorate policies, procedures, standards and protocols. Research nurses to practice at all times in accordance with the NMC code of professional conduct. Research nurses to remain up to date professionally as outlined by the NMC. Research nurses to develop practice as outlined in the Trusts strategy for nursing and midwifery. Professional Development Demonstrate self-direction in facilitating continuing education and acquiring related experience. Maintains awareness of current advances in cancer treatments, research and nursing practice and use this knowledge to maintain high standards of care for patients with cancer. Maintains own professional development in conjunction with the objectives of the Service and those identified at Performance and Development Review. Assume responsibility for continuing education by attending related workshops, rounds, seminars, conferences and courses as well as keeping up to date on current publications. Participate in the induction of new staff. Contribute to educational initiatives within the Cancer Services Directorate. To be aware of and adhere to all Trust policies and procedures, the Health and Safety at Work Act and the Data Protection Act. General

To adhere to the UCLH Service Commitment "Putting Patients First" and adopt a professional approach to customer care at all times.

To comply with the Trusts Equal Opportunities Policy and treat staff, patients, colleagues and potential employees with dignity and respect at all times.

To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Incident, Serious Incidents and Near Misses reporting policy and procedure.

To take personal responsibility for ensuring that UCLH resources are used efficiently and with minimum wastage, and to comply with the Trust's Standing Financial Instructions (SFIs).

To comply with Trust policies for personal and patient safety and for prevention of healthcare-associated infection (HCAI); this includes a requirement for rigorous and consistent compliance with Trust policies for hand hygiene, use of personal protective equipment and safe disposal of sharps.

In accordance with the Trust's responsibilities under the Civil Contingencies Act 2004, undertake work and alternative duties as reasonably directed at variable locations in the event of and for the duration of a significant internal incident, major incident or pandemic.

To be aware of and adhere to all Trust policies and procedures, the Health and Safety at Work Act and the Data Protection Act.

To maintain confidentiality at all times.

Other

These guidelines are provided to assist in the performance of the contract but are not a condition of the contract. The job description is not intended to be exhaustive and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

All staff will be regularly assessed on their knowledge, skills and behaviour, and application of all aspects of the job description, in line with the Trusts Personal Development Review (PDR) process.

Staff will also be expected to abide by the relevant code of professional practice relating to their discipline.

Person Specification

Knowledge & Qualifications

Essential

NMC First level registration or equivalent relevant degree Basic computer literacy Up to date GCP Training: For Clinical Trial Practitioner applicants

Desirable

Post registration oncology qualification or equivalent relevant qualification For Clinical Trial Practitioner applicants: Registration on the Academy for Healthcare Science Clinical Research Practitioner Accredited Register Competence in research orientated PC software (Access/Excel) Up to date GCP Training: For Research Nurse applicants

Experience

Essential

Significant experience of working clinically in cancer Experience of working with oncology/haematology patients Clinical trials experience: For Clinical Trial Practitioner applicants Experience of formal/ informal teaching of patients and staff Experience of explaining complex concepts to patients in a clear and simplified manner

Desirable

Clinical trials experience: For Research Nurse applicants Experience of phlebotomy and cannulation

Skills & Abilities

Essential

Demonstrates ability to work under own initiative and prioritise Demonstrates ability to take charge and delegate duties Demonstrates evidence of professional development Demonstrates understanding of the importance of audit/quality Proven knowledge of ICH GCP guidelines Proven ability to communicate effectively in writing Proven ability to work effectively under pressure Computer literacy