Address
Form of work
SalaryJOB PURPOSE The post holder will take responsibility for the overall set up, coordination and data management of Clinical Trials supporting and facilitating both academic and commercial Clinical Trials alongside a lead research nurse. The set up process and Quality Assurance are key aspects of this post. They will serve as the main contact point for all internal and external parties involved in set up, maintenance and close down of all Clinical Trials within their portfolio. They will be responsible for coordination of Clinical Trials, for the team, and also have a role in recruiting patients into Clinical Trials ensuring that all trial protocols are adhered to. The post holder will be familiar with ICH/GCP, and have good all round clinical trial management skills. Excellent IT skills with a working knowledge of Microsoft Office software are essential. You should be enthusiastic, and possess excellent communication, negotiation and organisational skills. Working autonomously, using your own initiative as well as possessing strong team working skills and an ability to motivate staff is essential. JOB DIMENSIONS The post holder will be responsible for the supervision of support staff i.e. Clinical Trials assistants and administrative staff, and will work under the direction of the research nurses within the team. Clinical Trials support is provided to a number of Chief and Principle Investigators. They will be working within a busy and expanding Clinical Trials department where the trials portfolio includes national and specialist group studies plus studies from the commercial sector. The post-holder will be expected to show evidence of considerable experience of working in a research environment. The number of patients in a trial can range from one to 50+ and the Co-ordinator will be expected to support the Senior Research Nurse/Midwife/Allied Health Practitioner (AHP) ensuring that the team meet all reporting and outcome deadlines. They will undertake regular auditing/monitoring to ensure that research complies with the UK Policy Framework for Health and Social Care Research. The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required. KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED The post-holder will be educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post. They would be expected to have experience of working in an organisation which includes interaction with multiple departments or organisations. The post holder will be expected to show a thorough understanding of all legal requirements related to trials and must be familiar with GCP/ICH guidelines and the Declaration of Helsinki. The post requires evidence of relevant experience of Clinical Trials co-ordination and data management skills. Excellent communication skills and the ability to provide and receive complex information in relation to study design are essential for this role. Excellent organisational, negotiation and presentation skills are essential, as well as the ability to work on their own initiative and as a team player. CORE BEHAVIOURS AND SKILLS Professional attitude to work, diplomatic and calm under pressure Ability to work as a team in a busy working environment Excellent communication skills, able to communicate at all levels Strong interpersonal skills Effective organisational skills Ability to prioritise and manage time effectively Ability to work autonomously and own initiative Proactive and flexible approach Motivated, friendly personality Commitment to personal development Coach and develop staff Ability to motivate staff CORE KNOWLEDGE AND UNDERSTANDING The post-holder will be expected to demonstrate complete understanding of Clinical Trial legal requirements and management. The post-holder will be expected to have knowledge of the complete trials process Experience of staff supervision would be desirable. Whilst a knowledge of Clinical Trials is essential, knowledge of the NHS and clinical area is desirable and would be an advantage
