The post holders main responsibilities will include providing professional, skilled nursing care to ensure safe and efficient running of Cardiovascular research studies. Ideally with experience in TAVI and or cardiac surgery. Responsibility for ensuring research has completed set up with full approval to proceed, screening, recruiting participants, collecting and entering data, responding to data queries and events. The appointee will also identify barriers to recruitment and overcome these. Communicate effectively within the wider MDT together with local R&I, study sponsors and representatives. Provide mentorship and education to other members of the team and assist the Senior Research Nurse.
* To develop and maintain constructive working relationship with muti-professional teams within the speciality.
* Have responsibility for ensuring good communication between all service providers within the speciality.
* Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality and cascade learning back to the team.
* Manage a personal caseload of clinical trials and patients independently with minimal supervision.
* Deliver research activities in a variety of settings; Cardiovascular BRC, outpatient clinics, hospital wards, theatre, cath labs and over the telephone.
* Support the Lead Investigator in delivering the funded study protocol and supporting the service associated budget.
* To ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines.
* To act as one of the primary points of contact for clinical trials patients.
* To educate other staff as to the responsibilities of the role and function of the research nurse and disseminate information on specific studies.
Four primary goals
* high-quality care for all,
* being a great place to work,
* partnerships for impact,
* research and education excellence
Strategy values
* we are compassionate,
* we are proud,
* we are inclusive,
* we are one team
* Organisation of any necessary tests and investigations as detailed within the protocol.
* Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.
* Undertake high risk clinical duties (advanced therapies).
* Maintaining logs of stored samples and freezer temperatures.
* Maintaining adequate stock levels of sample kits.
* Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
* Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments.
* Resolving data queries raised by sponsoring organisations.
* Archiving all study related material including patient's notes after study closure.
* Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated time frames to sponsor organisations and the Research and Innovation Office.
* Tracking Serious Unexpected Event reporting.
* Maintaining and updating study specific site files.
* Notify General Practitioners of their patient's involvement in a clinical trial.
* Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly.
* To maintain Professional Accountability for nursing research practice at all times. Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance.
* Provides education and support for patients in research trials. Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial.
* Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities.
* Responsible for resolving data queries raised by sponsoring organisations.
* Demonstrates commitment to the role of patient advocate for patients considering or participating in clinical trials.
* To provide mentorship and supervision for other research professionals and staff within and outside the department.
* Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved.
* Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement.
As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified; however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge.
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