Trust: Royal Devon University Healthcare NHS Foundation Trust
Location: Exeter, Wonford, EX2 5DW
Job Purpose:
The post holder will work as part of the clinical research team to support the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.
The post-holder will work with the research team to provide administrative, clerical and data management support for all aspects of research study delivery across an extensive portfolio of clinical trials.
Key Result Areas/ Principal Duties and Responsibilities:
Research and Governance
• Assist the clinical research team in coordinating a portfolio of National Institute Health Research (NIHR) studies.
• Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.
• Assist in study set up processes:
• Expression of interest & study selection documents
• Liaise with the study sponsor, R&D facilitator team, relevant support and research teams to assist in the successful set up of new studies
• Prepare submissions for local research and development approval
• Coordinate site initiation meetings
• Set up the local site file & collate documents
• Ensure EDGE is correctly set up & data correctly maintained throughout the study
Take a leading role in on-going study coordination including:
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