The following skills and experience will be required and are essential for the successful candidates: To work according to ICH Good Clinical Practice (GCP) guidelines and research governance standards for clinical trials and current Standard Operating Procedures (SOPs) To demonstrate in-depth knowledge of trial protocols and their application in practice alongside a working knowledge of how to comply with local, national and international research regulations. To manage a caseload of concurrent clinical studies following a range of complex clinical trial protocols and to contribute to the management of the local portfolio of clinical trials. To identify, screen and recruit participants into research studies according to the inclusion and exclusion criteria to ensure the effective achievement of study aims and monitoring of their condition throughout participation. To ensure that trial specific investigations are undertaken as required by the research protocol in order to establish eligibility and safety to enter the trial for its total duration.
To attend multi-disciplinary team meetings (MDT), and appropriate clinics, to screen and recruit new participants, and to act as a resource to the members of the MDT. To register/randomise participants into trials and to ensure that all clinical trial records, Case Report Forms (CRFs) and participant records are completed contemporaneously and maintained with a high degree of accuracy. These records may be in paper, optical or electronic form. To maintain accurate documentation of participant events in nursing/medical notes.
To identify barriers to recruitment to trials and ensure that the Network and R&D is aware of them. To support/action plans as required. Please refer to the for the full specification of responsibilities and requirements for this post.
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