Senior Research Nurse (Clinical Trials)

This is an exciting opportunity for a Senior Research Nurse to join our team at hVIVO working in the pioneering world of human based clinical trials. This is a full-time, permanent role based between Whitechapel, E1 and Canary Wharf, E14 (from mid 2024). hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methodologies across differing viral challenges. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

The Senior Research Nurse plays a key role in the coordination of clinical unit activities, appropriate staff scheduling, the development of quality service delivery, providing management, support and guidance to all staff and ensuring a GCP customer focused service from screening to final study visit. Practicing at an advanced level demonstrating a high level of autonomy and clinical decision-making, performing diverse responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes and staff development and engagement. Acting as clinical project lead from clinical start-up to close out, this role is responsible for providing support as study coordinator on trials, and as a line manager for Research Nurses. This role provides mentoring and supervisory support to the clinical team, study support to project teams and to maintain a ward environment conducive to study delivery. With other members of the senior clinical team, the Senior Research Nurse ensures that all staff work in accordance to evidence based nursing practice, maintaining high standards of care.

Main Responsibilities

• Responsible for leading studies from a clinical perspective from set up to close out of studies;
• Acting as a catalyst for change and improvement in performance quality at a cross departmental level;
• Hire, train, and manage Research Nurses, support staff;
• Creating and analysing metrics towards continuous improvement;
• Quality focused management, tracking training and procedural compliance;
• Overall responsibility for the supervision of clinical staff in the clinical environment, providing guidance and mentoring to Research Nurses and clinical support staff towards clinical excellence;
• Development and implementation of study delivery strategies commensurate with caseload, staff skill mix and resource;
• Active involvement in process improvements and development of SOPs and other procedural documents;
• Support Clinical Operations to ensure the appropriate clinical training is delivered and that desired standards of competency are monitored maintained and documented, including providing revalidation support;
• Interpret health legislation and directives with regard to their impact on, or applicability to the Research Environment and ensure effective implementation as appropriate;
• Ensure that staff apply current developments in clinical practice;
• Provide input to the hSITE Management Plan and maintain the hSITE Risk Register;
• Responsible for regular review of hSITE quality systems driving process change, CAPA completion and coordinating audit responses;
• Develops strategies to promote staff compliance with process and training;
• Preparing, planning and execution of daily clinical activities;
• Provide guidance and mentoring to staff in the clinical environment;
• Ensure competence in performing their own and team’s daily tasks;
• Supervision and training of new ancillary staff in the clinical environment as required;
• Create or review and complete study related documents e.g. SOPs, logs, source data and CRFs;
• Overseeing clinical consumables, equipment maintenance, emergency procedures and staff training;
• Promote and adhere to Company SOPs, protocols and Health and Safety Regulations;
• Study Coordinator; act as a lead nurse in given projects;
• Ensure volunteer safety and comfort by ensuring an infrastructure is in place for the volunteer journey.

Skills & Experiences

• Solid experience in leading clinical studies from set up to close out in an NHS or commercial setting;
• Good knowledge of Good Clinical Practice/Previous experience in a clinical trial setting;
• Ability to work with a degree of flexibility and multi-task;
• Demonstrated Leadership and strong motivational skills;
• Previous demonstrable experience of managing the workload of a nursing team;
• NMC Registered;
• Valid Immediate Life Support certification;
• Completed Immunisation and Vaccination (DPC Healthcare providers);
• Excellent time management and organisational skills;
• Good communication skills;
• Sound clinical knowledge;
• Ability to delegate and supervise;
• Ability to prioritise own workload;
• Competence in the recording of medical history, vital signs, ECG, phlebotomy and the ability and willingness to learn new skills;
• Demonstrated ability to manage a team of clinical professionals and create a productive, satisfying work environment;
• An understanding of ethical practice and confidentiality;
• Good IT skills including Word and Excel;
• Experience working within the UK healthcare structure a minimum of 12 months;
• Well-developed knowledge and understanding of clinical supervision.