This is an exciting opportunity to join the Advanced Immune and Cellular Therapy (AICT) Team 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. This is a fixed-term maternity cover post.
We are seeking an enthusiastic, highly 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 successful candidate will need to demonstrate a good understanding of the clinical trials process, Good Clinical Practice (GCP) and clinical governance, and be IT literate with previous experience of administrative work. We are looking for a candidate with good organisation and communication skills, who can work well both in a team and using their own initiative. The successful candidate will also demonstrate good leadership skills that promote an environment of quality and learning.
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. In order to support the growth of the AICT research portfolio, the successful candidate will work closely with senior research and operational staff to provide management support across a portfolio of complex early phase clinical trials.
They will act as the key coordinator for the AICT Research Team, ensuring the provision of a high-quality, efficient and responsive administrative service to support the successful delivery of clinical trials throughout the study lifecycle, from study set-up through to study closure and archiving.
The post holder will coordinate and oversee the administrative delivery of assigned clinical trials, supporting workload allocation across the Clinical Trials Coordinators whilst providing day-to-day guidance and line management support as required.
Working in partnership with senior research management and the multidisciplinary clinical team, the post holder will support compliance with Trust policies, Good Clinical Practice (GCP), ICH-GCP and all other applicable regulatory requirements.
The Christie is one of Europe’s leading cancer centres, looking after more than 64,000 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 25% patients are referred to us from other parts of the country.
We are the largest radiotherapy provider in the NHS with one in 20 treatments delivered at The Christie. We have up to 15 linear accelerators operating across our network of sites. We operate the largest chemotherapy unit in the UK on our main site and treatments are also provided at 13 other networked sites, and in patients homes. And as a specialist tertiary surgical centre, we focus on rare cancers, complex procedures, and multidisciplinary approaches to cancer surgery, specialising in colorectal, peritoneal, gynaecological, urological and plastic surgery.
We are also an international leader in research, with world first breakthroughs for over 100 years. We have been named by the UK’s National Institute for Health Research (NIHR), as one of the best hospitals providing opportunities for patients to participate in clinical research studies, with more than 800 studies open at any time, caring for over 3,000 patients.
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, work allocations and patient recruitment.
- Ensure that data is available and up to date for any meetings related to the trial/ study, producing minutes as required.
- Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
- Attend 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’s archiving guidelines.
- Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment teams.
- Demonstrates the agreed set of values and accountable for own attitude and behaviour
WORKING PRACTICE
- Work closely with the Senior Research Management Team to implement new SOPs and working procedures within designated teams.
- Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
- The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to senior managers as necessary.
- The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas.
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 and 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.
