Senior Clinical Trials Coordinator

This is an exciting opportunity to join the Experimental Cancer Medicine Team (ECMT) at The Christie NHS Foundation Trust; an international leader in cancer research and development and the largest cancer treatment centre of its kind in Europe.
The post holder will have experience in clinical trials administration, particularly in trials set up, and will work alongside the clinical team on a portfolio of early phase trials.
We are seeking an enthusiastic, motivated and experienced individual who will be responsible for various aspects of clinical trial coordination including liaising with trial sponsors, monitors and the wider research community, maintaining essential documentation, managing the set-up of new studies and overseeing the day to day running of open studies.
The post holder will act as the key co-ordinator for assigned clinical trials administration teams to proactively ensure the provision of a comprehensive, high quality and efficient administrative service. They will be involved in work allocation and monitoring across these teams, as well as their own workload comprising of trial co-ordination and data management as appropriate to the needs of their assigned teams. They will also be responsible for providing line management support activities for administrative team members as required by the post holder’s line manager.
The post holder will support the work of the Clinical Research Teams to ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements.
The post holder will support the Clinical Research Teams in the administration of clinical trials from feasibility to archiving including (but not limited to):
Facilitate the efficient and timely set up of clinical trials including financial negotiations.
Ensure tracking and payments of invoices for their clinical trial portfolio.
Ensure quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
Preparation for audit and inspections within assigned teams and implementation of action plans.
The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.
We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.
We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
TEAM SUPPORT
Responsible for supporting and supervising workload allocation/ monitoring across administrative team members, escalating issues as appropriate to senior managers.
Provide support to senior managers with general Human Resource activities, including but not limited to recruitment and selection and line management of administrative team members as required. This will be in accordance with Trust policies.
Provide induction support and training to new and existing clinical trials staff through one-to-one and group learning activities.
Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
Assist with data collection for divisional metrics reports of key performance indicators.
CLINICAL TRIALS CO-ORDINATION/ DATA MANAGEMENT
The specific responsibilities will depend on the requirements of each team, but may include:
Act as a key point of contact with the core Research and Development team, study sponsors, clinical research organisations and specific research teams.
Support feasibility activities for new studies under direction from senior managers and Principal Investigators.
Manage the set up and initiation of allocated clinical trials within assigned Clinical Research Teams. Provide support for study set up and initiation that has been delegated to Clinical Trials Coordinators, escalating any delays as appropriate.
Support with negotiations of study set-up costs and income recovery for assigned clinical trials in conjunction with the Research Division’s Business Planning and Finance teams with oversight from senior managers.
Oversee maintenance of investigator site files and essential documentation in accordance with ICH-GCP and Trust Standard Operating Procedures (SOPs) to ensure they are kept inspection ready at all times.
Oversee and process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, escalating any delays with the core Research and Development office as appropriate.
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