Essential
To support the collection of clinical trial information and research samples in line with research legislation, adhering to procedures to ensure that confidentiality, accuracy, and security is maintained at all times and ensuring data collected meets required criteria.
To conduct clinical assessments as per protocol within scope of practice and actively support the conduct of research trial(s) according to agreed research governance standards and legislation.
To liaise with investigators, research delivery staff, research and development department, clinical departments and staff across RPH in respect of the study feasibility, set up and delivery and monitors the progress of that research study.
To be able to demonstrate use of a range of judgement and assessment skills in planning, delivering and evaluating complex patient care plans as per trial protocol whilst communicating with patients, families and the multi-disciplinary team. The post holder will be expected to manage routine studies but will be supported by their senior colleagues.
To support complex patients with their potentially unpredictable care/treatment needs whilst participating in a clinical trial; ensuring care delivered is evidence based.
The post holder will provide clinical services by undertaking diagnostic and research tests on patients for research purposes.
The post holder will provide, implement and evaluate clinical knowledge and expert advice to the patient on the research study including any research treatment that needs to be considered alongside their substantive care plan.
To be able to prioritise care based upon patient safety trial information need in a busy clinical environment and effectively prioritise own workload in line with local and regional targets and clinical trial visits in accordance with protocol-mandated timelines and existing clinical appointments, escalating as necessary
To be able to undertake occasional moving and handling tasks relating to patient care utilising mechanical aids with some tasks requiring moderate effort.
The post holder will have occasional exposure to some emotional / distressing incidents and frequent exposure to bodily fluids including from research sample collections, processing and shipping.
To be able to effectively communicate complex, confidential, and/or sensitive condition related information through a range of interpersonal skills to colleagues, patients/visitors and external organisations (eg trial sponsors) (such as providing educational support, complex research planning); and to support patients to be able to make informed choices about health and treatment options related to clinical research trials.
To act as a patient advocate when necessary, safeguarding and promoting the interests of patients and carers. This may involve explaining research procedures and the nature of the patient's medical condition, in conjunction with the specialist clinical team, to ensure full understanding.
To provides accurate and appropriate support for patients in conjunction with clinical nurse specialists and senior research colleagues.
To work effectively within the research and development and clinical teams, maintaining professional relationships and good communication by participating in multi-disciplinary research team meetings.
To act in a professional manner and as a role model to other staff members, providing day to day clinical supervision of junior staff as well as patients and their families/carers.
To understand the process of escalation within the trust ensuring this is done promptly to ensure patient and staff safety and recognising and raising any safeguarding concerns; including escalation to senior colleagues/investigator/ sponsors (as appropriate) under ICH GCP guidelines regarding adverse event documentation and reporting.
To uphold Trust policies and procedures, knowing when to appropriately escalate and to act independently within own regulatory body Code of Conduct as appropriate.
To be responsible for the day-to-day supervision of trial back up staff within their teams including allocating patient research activities.
To support with the orientation of new staff, mentor new junior staff as appropriate (including research interns and student nurse placements); and support on-going staff development.
The postholder will take responsibility for own continuing professional development and ensure own knowledge remains current and is evidence based; and keeps abreast of current research and government issues relating to research and disseminate information as appropriate.
To participate in reviewing policies and procedures to improve outcomes and the quality of service provided and actively participate in the implementation of any changes in practice within the clinical area, in line with statutory and NHS guidelines; and ensure timely dissemination of any agreed changes in practice.
To support senior research colleagues with regular verbal and comprehensive written reports to the study investigators/study sponsors.
To support senior research staff/line manager with monitoring/assessing and reporting in relation to both clinical and non-clinical risks and incidents.
To maintain accurate database entry/record keeping that is consistent with all legislation, policies, and procedures and , with the support of senior research colleagues, to anticipate, problems and issues on available data and identify and implement solutions.