Clinical Research Manager

at  Nottingham University Hospitals NHS Trusts

To support the Clinical Research Delivery Manager in providing effective leadership, supervision, and line management, of the Clinical Support Clinical Research Team, and other members of the wider NUH research team; this will include Research Nurses, AHPs, Administrators and associated staff. To assist the Clinical Research Delivery Manager to monitor and manage staffing levels for all Clinical Support Division Portfolio studies. To assist the Clinical Research Delivery Manager with ensuring NUH Mandatory training needs are met within the Clinical Support Division Team of Research staff. To support the Clinical Research Delivery Manager with the oversight and support of the Support Departments supporting research across the whole trust.
To ensure that all Research Nurses/Practitioners/Allied Health Professionals and Investigators are practicing in line with recommendations of ICH Good Clinical Practice (GCP) and to identify and respond to areas of training need. To assist the Clinical Research Delivery Manager with the recruitment and selection, development, training and retention of relevant staff and all other aspects of people management including performance management, sickness etc. To advise Senior Clinical Nurses, Lead Clinicians, Service Managers and Scientists of any research issues and changes in practice that may be relevant to their work or have resource, service or research implications. To ensure that clinical study recruitment records are accurately maintained.
Manage time and resources effectively including chairing relevant meetings, taking minutes and keeping accurate records. To access the computer network as required to access relevant information. To work as part of the NUH R&I management team and contribute to the ongoing development of the NUH Research Strategy. To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation. Deputise for the Clinical Research Delivery Manager at meetings as directed. To be responsible for maintaining strong relationships and positive communication channels with clinical directorates, other key personnel and commercial sponsors. Clinical Responsibilities and Duties To attend to and supporting patients in the clinical environment for monitoring, assessment and follow up as part of research projects.
To identify and screen patients for studies and databases. To co-ordinate your own case-load of clinical studies and the participants. To ensure clinical trial protocols are adhered to. To ensure that you are working according to ICH Good Clinical Practice and Research Governance standards for clinical studies.
To ensure trial participants are managed safely according to Trust policies and guidelines. To register/randomise participants into studies and to be involved in the informed consent process. To liaise with external clinical study personnel as necessary. To supply data as required to the PI regarding progress of clinical studies.
To identify barriers to recruitment to studies and ensure that the Principle Investigator is aware of them. Identify and implement action/plans as required to remove these barriers. To identify to the Clinical Research Delivery Manager /Clinical Lead any future staffing needs which may impact on ability to deliver studies on time To provide support for clinical research colleagues in their absence. To attend meetings relevant to the nature of the post.
To ensure the safe administration of treatments and drugs within the context of a clinical study. To ensure that study specific investigations are undertaken as required by the protocol, in order to establish eligibility and safety to enter the trial. To provide ongoing information, education and support to volunteers regarding clinical studies. To ensure blood and other samples are collected for pharmacokinetic studies as required by the study protocol.
To maintain accurate documentation of research related activities in Study, Nursing and Medical notes. To accurately record data collected in the Case Report Forms (CRF). To monitor treatment toxicity / side effects and initiate changes to treatment as required by the protocol. To record and report adverse events to the relevant personnel and take any necessary action.
To report and record serious adverse events to the Trial Co-coordinator/Principal Investigator (PI) and relevant local personnel / Regulatory Authorities. To provide ongoing follow up care whilst a subject is in a clinical study. To act as a primary contact point for patients/subjects in a clinical study. To follow appropriate Trust Policies and Procedures and to ensure that you are working according to Good Clinical Practice and Research Governance standards for clinical studies To ensure all necessary Regulatory items are in place prior to study commencing.
To ensure that clinical studies are archived as required

Please refer the Job description for details