Clinical Research Nurse

at  hVIVO Services Limited

Overview:
This is an exciting opportunity for a Research Nurse to join hVIVO to support the daily planning and execution in our viral challenge unit in Canary Wharf (E14).
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 Research Nurse plays a key role in the provision of cost-effective nursing support and duties for optimal study delivery from clinical start-up to clinical close out as either an individual contributor, performing study coordinator duties on trials, or as a line manager to the support roles.
The shift patterns for this role are as follows, with the roster provided a month prior.
0730 - 1530 AM shift
1230 - 2030 PM shift
1930 - 0830 Night shift (approx 3 per month)

Main Responsibilities:

• To maintain and promote the safety and wellbeing of all subjects participating in a clinical trial within the regulatory frameworks of ICH GCP, other statutory instruments and NMC Code of Conduct.
• Assist the senior team with the daily management and allocation of workload within the clinical environment
• Involvement in 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 of new ancillary staff in the clinical environment as required;
• Promote and adhere to Company SOP’s, protocols and Health and Safety Regulations; and
• Support Clinical Support Specialists in performing clinical assessments as per protocol;
• Perform nurse specific procedures as identified within the protocol;
• Performs informed consent procedures as identified in the study protocol;
• Completion of study related documents e.g. logs, source data and CRFs;
• Adhere to Company SOPs, protocols and Health and Safety Regulations;
• Use of expertise to input into the development of SOPS and other procedural documents;
• Maintain subject safety at all times responding to emergencies as per internal SOP and national guidelines and protocols;
• Monitoring and identification of the deteriorating subject, with appropriate escalation;
• Responsible for the checking of emergency resuscitation equipment as per SOP/OIs;
• Responsible for maintenance of medicines management within the clinical department as per SOP/OI;
• Responsibility for the supervision of clinical staff in the screening unit as delegated by the Senior Research Nurse;
• Identification of areas for service improvement;
• Promotes a high standard of practice and care at all times

Skills & Experiences:

• Knowledge of GCP and previous experience in a clinical trials setting desireable
• Competence in the recording of medical history, vital signs, ECG, phlebotomy etc essential
• Ability to manage adverse events or clinical incidents
• Good knowledge of ICH-GCP and regulatory standards
• Nursing qualification essential
• NMC registration essential
• Completed Immunisation and Vaccination (DPC Healthcare providers)
• Certificate in basic or intermediate life support essential
• Sound clinical knowledge
• Good patient communication skills essential
• Ability to work within the Team
• Good time management skills
• Effective organisational skills
• Ability to work with a degree of flexibility
• Ability to prioritise own workload
• An understanding of ethical practice and confidentiality
• Good IT skills including Word and Excel
• Strong and demonstrated attention to detail
• Willingness to learn additional skills
• Ability to work independently and within the team
• Positive and Supportive Team player
• Previous experience managing the workload of a nursing team desirable

• To maintain and promote the safety and wellbeing of all subjects participating in a clinical trial within the regulatory frameworks of ICH GCP, other statutory instruments and NMC Code of Conduct.
• Assist the senior team with the daily management and allocation of workload within the clinical environment
• Involvement in 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 of new ancillary staff in the clinical environment as required;
• Promote and adhere to Company SOP’s, protocols and Health and Safety Regulations; and
• Support Clinical Support Specialists in performing clinical assessments as per protocol;
• Perform nurse specific procedures as identified within the protocol;
• Performs informed consent procedures as identified in the study protocol;
• Completion of study related documents e.g. logs, source data and CRFs;
• Adhere to Company SOPs, protocols and Health and Safety Regulations;
• Use of expertise to input into the development of SOPS and other procedural documents;
• Maintain subject safety at all times responding to emergencies as per internal SOP and national guidelines and protocols;
• Monitoring and identification of the deteriorating subject, with appropriate escalation;
• Responsible for the checking of emergency resuscitation equipment as per SOP/OIs;
• Responsible for maintenance of medicines management within the clinical department as per SOP/OI;
• Responsibility for the supervision of clinical staff in the screening unit as delegated by the Senior Research Nurse;
• Identification of areas for service improvement;
• Promotes a high standard of practice and care at all time