Please note that this post is offered at full‑time hours (37.5 h/week)
An exciting opportunity has arisen within the Research and Innovation Division at The Christie. We are looking to appoint a Senior Clinical Trials Coordinator to the Breast clinical research delivery team within The Christie NHS Foundation Trust. We are seeking an enthusiastic and highly motivated individual, who has demonstrated significant work experience in clinical trials coordination and data management, and a good understanding of clinical research, GCP and clinical governance.
Applicants should have excellent organisation and communication skills, work well both in a team and on their own initiative, and demonstrate good leadership skills that promote an environment of quality and learning. The role is ideal for individuals keen to pursue a managerial career in clinical trials coordination and will provide the necessary skills and experience to become a future leader in this field.
Applicants must meet all essential criteria, including holding a scientific or business‑based degree, or have relevant experience in scientific and medical research.
Main duties of the job
The focus of this role is to provide support to sustain and improve an excellent level of service provision from a trial site perspective for our research partners. A tailored training programme will consolidate the skills required to provide multi‑team management support for the Clinical Trial Research teams in the trust.
We are looking for a key coordinator for the Breast Research team to proactively ensure the provision of a high quality and efficient administrative service.
Key responsibilities
The role will include all phases of research and require the set up and coordination of complex clinical trials. Previous experience of study set up of complex trials would be desirable. The post holder will be expected to provide managerial and leadership support to senior R&I management and clinical research staff, and ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements.
Opportunities will be available to lead service development projects within the team and the wider R&I division.
* 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 negotiations of study set‑up costs and income recovery for assigned clinical trials in conjunction with the Research Divisions Business Planning and Finance teams.
* Oversee maintenance of investigator site files and essential documentation in accordance with ICH‑GCP and Trust Standard Operating Procedures (SOPs) to ensure they are inspection‑ready at all times.
* Oversee and process trial amendment submissions in accordance with ICH‑GCP and Trust SOPs and timelines, escalating any delays.
* Ensure that adverse event incidents and forms are completed, reported and followed up to resolution as required by protocol and regulations.
* Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing updated 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 case report form completion timeliness, data locks, data backlogs, work allocations and patient recruitment.
* Ensure that data is available and up to date for any meetings related to the trial, producing minutes as required.
* Attend project‑related meetings, investigator meetings (abroad or teleconferences, as necessary) and disease‑specific research team meetings to maintain an overview of team activity.
* Assist with preparation for audit and inspections within assigned teams and implementation of action plans.
* Ensure that all documents are archived in the appropriate way by following the Trust archiving guidelines.
The post holder is expected to use initiative and work independently without close supervision, plan and organise their own time and workload activity with prioritisation, and exercise judgement outside of relevant protocols and SOPs.
Working practice
Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams. Be proactive in providing feedback on working practices within the research team and suggest new ways of working.
Personal and people development
Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework. Participate in and deliver Trust‑wide education programmes, study days, regional and national meetings and research seminars as appropriate.
Physical, mental and emotional effort
Long periods of time spent using keyboard to input information and use of VDU for electronic communication. Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets). Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.
Person specification
Qualifications
* Degree in a science or health related discipline
* Relevant experience in scientific and medical research
* Postgraduate certificate in clinical research or another relevant postgraduate qualification
* In possession of or working towards an NHS leadership academy qualification
Experience
* Significant experience in clinical trial administration and clinical trial data management
* Experience of mentoring junior staffPrevious experience of working in the NHS or other healthcare system
* Involvement in education and staff development
Skills
* Ability to prioritise own and others workload and practice effective time management
* IT literate including good understanding and demonstrated use of the full Microsoft Office suite
* Accuracy and attention to detail
* Excellent interpersonal skills
* Advanced use of spreadsheets
Knowledge
* Good understanding of the clinical research delivery processes, related standards, governance and legislation
* Understanding of medical terminology and cancer
* Understanding of case report forms
* Knowledge of patient information systems
Values
* Ability to demonstrate the organisational values and behaviours
Other
* Ability to work to tight and or unexpected deadlines
* Flexible with ability to adapt to service requirements
* Conscientious and hardworking
* Ability to work unsupervised or as part of a team
* Tactful and diplomatic
* Evidence of achievement under pressure
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and therefore a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions is required.
£32,073 to £39,043 a year per annum, pro rata
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