Clinical Research Practitioner/Research Nurse

Patient care Your primary concern will be to maintain patient safety during the conduct of clinical studies. The post holder will be responsible for: Coordination and facilitation of clinical research projects, managing them to the relevant standards. Screening of case notes for recruitment of appropriate candidates and discussing with patients about the opportunity to join a relevant study. Coordinating and supporting medical, nursing and technical staff to successfully complete research projects and the execution of clinical trials Participation in the execution of clinical studies taking patient samples, testing prototype medical equipment, performing analysis on patient samples Facilitating the research study process including scheduling patient admissions and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocolBeing the point of contact for study participants, giving advice on the relevant study and correlated health issues Ensuring that nursing/ multidisciplinary team (MDT) documentation is maintained to the Trust and GCP standards Introducing improved systems of research conduct and management to enable successful project delivery Ordering and purchase of equipment using online systems including interaction with University based staff and systems Trust-wide clinical research polices and protocols, insuring their implementation Analyse research data, ensuring consistency and accuracy. Identify key errors in data collection/entry and address or flag as necessaryIdentify system errors in bespoke data management systems (e.g. electronic case report forms) and provide feedback to the respective team and study nurse Address recurrent data queries which may highlight system problems or data collection issues Assist with ensuring that study equipment has the ability to download information as required by the study protocol During research visits, specific duties will include, although not exclusively consist of: Height and weight measurements Collection of vital signs Recording adverse events and changes in medication Performing lung function, ECGs and sweat tests Sputum induction and sample collection Collection of breath samples Obtain blood samples by venesection Administration of Quality of Life questionnaires Supervision of study drug dosing Training will be provided as needed in all of the above procedures. Communication Arranging and attending team meetings Writing and circulating summaries of monthly meetings as requested Have an active email account and share information appropriately Document all adverse incidents as required by study protocols Report to local, national and international project partners as required Report on the technical and clinical performance of the studies as required Participate in local, national and international meetings People management Coordinate the participation of nursing, practitioner and medical staff to ensure the trials are completed within the project timetable Ensure that they themselves and others involved in a study have the correct training to undertake the procedures. Ensuring that they and the team are up to date with their mandatory training Organise own work on an ongoing basis, arranging one-off or recurring events, including training, Site Initiation Visits and Monitoring Visits Policy and Service Development You will be responsible for maintaining trial data to the relevant standards required for the study. This will include: Maintaining Trial Master Files to Medicines and Health Regulatory Authority (MHRA) standards Maintaining Investigator Site Files Collating source data Electronic reporting of trial data Checking, filing and monitoring patient consent forms Creating systems for data gathering and trial conduct such as standard operating procedures (SOPs) Entering data onto database Aiding statistical analysis Implement the trust policies & protocols within the department In conjunction with the lead investigator for each project and/or the senior team, you will assist with writing and make available all SOPs, policies and guidance notes that will be needed by the research team to ensure the safe conduct of the clinical trials. Trial SOPs will conform to all relevant Policies such as Infection Control, Data Protection, Human Tissue Act. Resource management Manage an inventory of consumables and equipment required for specific studies Record the use of any materials expended by the group in the conduct of the trials Purchase any additional equipment needed to conduct trials Report expenditure accrued in the conduct of clinical trials Arrange reimbursement of expenses to patients participating in research studies To attend relevant meetings To undertake any necessary training and/or development Information management Further sections To ensure all mandatory training courses such as Manual handling, Fire, Resuscitation, health and safety are attended on an annual basis and the knowledge gained adhered to. To abide by the Trusts core behaviours for staff and all other Trust policies including standing financial instructions, research governance, clinical governance, patient and public involvement, codes and practices, and health and safety policies This job description is intended as a basic guide to the scope and responsibilities of the post and is not exhaustive. It will be subject to regular review and amendment as necessary in consultation with the post holder.

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