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•The post holder will be directly responsible for project management, education and training of medical staff and other staff interested in research, liaising with laboratory staff and ensuring the project is conducted within the budget.
Clinical Trial Co-ordinator Job Description
• Educated to degree level in relevant subject i.e. nursing, psychology, business management
Knowledge & Experience
• Extensive experience of working within a clinical research context, preferably pharmaceutical trials
• Experience of project management and able to provide examples of successful implementation of a project.
• Experience of clinical research and knowledge of Good Clinical Practice (GCP) and Research Governance for Health and Social Care.
• Specialist knowledge of ICH GCP in relation to research studies on elderly patients
• Specialist knowledge of research techniques, data collection, analysis and use of information
• Able to communicate difficult theoretical data in relation to research projects and trials to health professionals and patients
• Able to communicate research findings both orally and in writing
• Able to communicate complex patient related information to a patient or other health professional
• Able to communicate highly sensitive information to staff, parents and patients
• Able to communicate to high standard in Spanish
• Ability to analyse and interpret research protocols and project findings
• Able to make judgements and advise others on a range of clinical issues or complex patient conditions
• Ability to work autonomously and as part of a team
• Ability to plan and organise multi disciplinary research programs, projects and trials
• Experience of prioritising and managing workload of others
• Able to exercise own initiative when dealing with issues within own specialist area.
Able to use MS word, PowerPoint & excel software packages
• Experience of working with different databases and ability to extract information.
• Ability to travel between research sites
Mental • Able to concentrate for prolonged periods when recording patient data
• Able to deal with complex organisational issues i.e. ensuring the delivery of clinical trial stocks are delivered to appropriate site at the correct time
Working conditions • Able to work effectively with patients combined with managing a busy research team
Project Start up and Preparation
1. Will be responsible, in liaison with the research manager for ensuring the documentation required for research approvals at research sites is managed in a timely manner
2. Will be solely responsible for the education and training of medical staff regarding the project conduct and recruitment of participants
3. Will work with all parties involved in the project, including the laboratory staff to ensure the project starts in a timely manner.
4. Is responsible for ensuring that all resources and materials are prepared and ready for the start of the project at each recruitment site
Is directly responsible for implementing processes to evaluate and monitor that the project is conducted in accordance with the protocol
1. Is responsible for reviewing and monitoring all processes and problem solving in order that the project is run in an efficient and timely manner
2. Ensures that effective communication is ongoing to ensure all medical staff are aware of their responsibilities within the project.
1. The post holder will develop and identify the learning needs of the various teams within the project regarding recruitment and testing and implement a programme of education, which will be reviewed on an ongoing basis
2. The post holder will ensure that any significant results are acted upon immediately to ensure the patient has access to the appropriate services and follow up care
1. The post holder will assist the Chief Investigator in preparing the final study report, including budget report for the Sponsor.
2. The post holder will inform the medical and support staff of the outcomes of the project.
3. The post holder will also assist in the writing of the final paper for publication by providing all the data required and assisting in the writing of the relevant papers for publication.
3. The post holder will regularly clarify and feedback any issues to the medical staff in relation to the conduct of the project
4. Is responsible for arranging regular meetings with the steering and advisory group, organising venue, agenda, taking and writing up of minutes.
5. Is responsible for ensuring that the ongoing recruitment of patients to the project is consistent and in line with the protocol and project timelines
6. The post holder will produce recruitment strategies and processes which they will assess, monitor and evaluate their success and amend accordingly.
7. The post holder is responsible for ensuring all medical staff are documenting in the patients notes that the patient is participating in the project and that it is in accordance with GCP standards.
8. The post holder is responsible in liaison with the Research Manager to manage the study budget and ensure that the project is conducted within budget.
9. The post holder will produce regular updates on recruitment and the progress of the project to the steering group. These updates will be in written and graph formats.
10. The post holder will have a vital role in collating required regular written reports which will be forwarded to the grant giving body at the European Commission.