Clinical Trial Practitioner/Research Nurse

Job overview

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.

If you would like further information, please contact Amy Smith, [email protected] or

Adrienne Abioye, [email protected].

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 in Lymphoma and Myeloproliferative Neoplasms .
• 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.

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 (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.

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 research nurses, trial practitioners, data managers 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 Trust’s 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 Trust’s 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 Trust’s Personal Development Review (PDR) process. Staff will also be expected to abide by the relevant code of professional practice relating to their discipline.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Come and be a part of the best NHS trust in England to work for, according to our staff*

UCLH top trust to work at in England – for the second year running! : University College London Hospitals NHS Foundation Trust

*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England – for the second year in a row.

UCLH top trust to work at in England – for the second year running! University College London Hospitals NHS Foundation Trust.

Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.

This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found at https://www.nhsemployers.org/articles/pay-scales-202425