My Client a specialist early-phase CRO, are recruiting for a Lead Clinical Research Nurse to work on viral based early phase studies in the London area.
The main aim of the role is to play a key part in delivering strong management of nursing services within a specialist clinical research unit.
· Provide guidance and mentoring to Research Nurses, Clinical Administrators and Viral Challenge Clinical Support Specialists (CSS) in the quarantine unit environment;
· Use of expertise to input into the development of SOPS and other procedural documents;
· Assist the Viral Challenge Manager in assessing staffing requirements and input in overall scheduling of staff;
· Responsibility for the supervision of clinical staff in the quarantine environment as delegated by the Viral Challenge; and
· Will be trained as expert user in RVL's electronic source data capture system (Clinical Ink) and will provide support to other medical staff
In conjunction with the Viral Challenge Manager, the Viral Nurse will act as a lead nurse in given projects and either execute or supervise the execution of the following:
· Review and input into study protocols for logistical and medical feasibility;
· Identify staffing requirements;
· Analysis of projected study timelines and subject screening estimates, and scheduling of sufficient Clinics to meet appointment demand;
· Working with Project Director (PD) to customize source documentation templates for a specific study;
· Attend internal study specific training and kick-off meetings;
· Attend sponsor initiation, monitor, and close out visits;
· Record and track study medication dispensed to volunteers during the course of the trial;
· Record subject information into the source documentation and/or CRF as per study requirements;
· Complete study specific documentation e.g. subject enrolment logs, IMP dispensation logs; and
· Identify and act on study specific training needs;
Duties will include but are not limited to.
· Performing clinical assessments as per protocol
· Completing study related documents e.g. logs, source data and CRF's
· Adhering to Company SOPS's, protocols and Health and Safety Regulations.
This job description reflects the core activities of the role and as the company and as the individual in this role develops there will inevitably be changes in the emphasis of duties. It is expected that the job holder will recognise this and adopt a flexible approach to work and be willing to participate in training.
For more information call Charles Sealey on 020 3465 0026
Deadline: 10 January 2014