Senior Clinical Trial Coordinator

7 months ago

Manchester, United Kingdom The Christie NHS Foundation Trust Full time

We are looking to appoint a Senior Clinical Trial Coordinator (Band 5) to the Breast research team within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division.

We are seeking an enthusiastic, motivated and experienced individual who will be responsible for assisting the research nurses, consultants and trial coordination management team with various aspects of clinical trial administration/ coordination.

The post holder will act as the key co-ordinator for assigned clinical trials to proactively ensure the provision of a high quality and efficient administrative service. You will be involved in work allocation and monitoring within the team, as well as your own workload comprising of trial co-ordination and data management, including study set-up, ongoing study management using your communication skills to liaise with trial sponsors, monitors, core R&I and the wider research community. You will be responsible for providing line management support for administrative team members as required by your line manager. Opportunities will be available to be involved in service development projects within the team and the wider R&I division.

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.

We strongly recommend that you get in touch to discuss the role with us.

DUTIES AND RESPONSIBILITIES

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, reported and followed up to resolution as the study protocol and regulations require.
- Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing up-dated information on patients included in the study.
- Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
- Liaise with internal staff and external collaborators to resolve queries.
- Provide information for senior managers including (but not limited to) case report form completion timeliness, data locks, data backlogs

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