Senior Clinical Trials Coordinator

The Christie NHS Foundation Trust is an international leader in cancer research and development and is the largest cancer treatment centre of its kind in Europe.

We are looking for a highly motivated person, interested in clinical research to improve patient treatment outcomes with Advanced Therapies in oncology. Advanced therapy refers to new medical products that use gene therapy, cell therapy, and tissue engineering to treat diseases and they have huge potential for the future of medicine.

The senior clinical trial coordinator is an exciting and developing role within The Christie, supported through the R&D division with a good education and development package to ensure staff reaches their potential. The post holder will coordinate the clinical trial portfolio, ensuring trials are set-up in a timely manner and data entry is up to date according to the highest standards. In addition, the role encompasses the line management of junior clinical trial coordinators in the team.

Please visit our website to see the developments at The Christie.

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 NHS Foundation Trust, situated in south Manchester, is the largest cancer treatment centre of its kind in Europe and an international leader in cancer research and development.

In 2018 The Christie NHS Foundation Trust was once again rated as Outstanding by the CQC health regulator becoming the first specialist trust in the country to be given their highest accolade twice

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.
- To have the appropriate administrative processes in place to ensure, with the Clinical Research Team, that adverse event incidents and forms are completed, repo