Liver Research Administrator
Job summary
The post holder will be an enthusiastic and motivated individual who will be responsible for assisting the liver research team with a variety of administrative tasks as well as ensuring confidential and sensitive information is kept secure. The post holder will support the coordination of a diverse portfolio of non-interventional, device and CTIMP studies, ensuring accurate tracking of study set-up, recruitment and governance activities across multiple research systems.
This is a role with lots of variety and ad hoc demands and so the post holder will possess excellent time management and planning skills. The band 3 administrator will work closely with Liver Research Nurses, Research Assistants, Data Managers, Coordinators, Medical staff and Clinical trials sponsors and representatives. The post holder will assist with regulatory and governance administrative tasks and will work independently by following the policies and procedures for the division. The band 3 administrator will also be expected to use their own initiative and keep line manager and senior colleagues informed.
Administration skills, IT skills, prioritisation and organisational skills along with excellent communication are essential for this role. The post holder must demonstrate the ability to manage their own work load effectively in a busy environment. Knowledge of the research process, along with the structure of research within the UK and guidelines relating to Good Clinical Practice is essential.
Main duties of the job
Responsible for the organisation and maintenance of filing systems within the Department; inputting information/patient activity onto any computerized systems and ensuring accurate retrieval and distribution of information.
To perform archiving duties for records held within the Research Office
To organise and issue access documents to visiting Sponsors and affiliates, as supervised by the CTC's.
Support the maintenance of electronic Trial Master Files (eTMF) and digital study documentation systems in line with sponsor and regulatory requirements
Assist in the tracking of study milestones, including study set-up, amendments, recruitment and close-out across the portfolio
Maintain the TMF/ISF with essential documents including electronic systems, ensuring inspection readiness at all times
Assist with tracking of regulatory approvals, amendments and study documentation to ensure compliance with MHRA, HRA and REC requirements
Organise initiation meetings
Maintain oversight of delegation logs, training records and GCP compliance for research staff
Support coordination of monitoring visits, audits and inspections, ensuring documentation is complete and accessible
Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
Maintain a database of staff involved in Liver research and coordinate re-training of staff who require it.
About us
The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
Job description
Job responsibilities
Responsible for anticipating secretarial needs of and for supporting the agreed members of the research team. This will include arranging meetings, ordering and collecting patient notes, travel and general diary management.
Support the R&D Leads in the collation and production of reports, plans, and other documents
Responsible for taking, transcribing and circulating minutes of formal meetings as required and within the agreed timeframe.
Deal with telephone and face to face enquiries, initiating action as appropriate
General photocopying and collating of documents
Booking taxis and couriers for staff, patients and packages.
Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms and arranging catering, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.
To be responsible for maintaining adequate stocks of stationery, ordering when necessary, to ensure the sooth running of the department.
Be the designated point of contact for patients who are claiming travel expenses and be responsible for processing claims/liaising with R&D Finance to ensure payment.
Collect and provide information to allow for invoices to be raised for payments where appropriate
Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.
Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract.
Person Specification
Education and Qualifications
- Educated to degree level standard or equivalent experience
- GCSE A-C (or equivalent) in English and Mathematics
- Good Clinical Practice E3R6 training
Knowledge and Experience
- Experience of working in an administrative role within a busy environment
- Experience of managing and prioritising a varied workload with competing demands
- Experience of working with databases and electronic record systems
- Awareness of clinical research processes and current regulatory requirements
- Working knowledge of Good Clinical Practice (GCP) and UK clinical trials regulations
- Familiarity with research systems such as EDGE, IRAS, or electronic Trial Master File (eTMF) systems
- Experience of maintaining study documentation (e.g. site files, logs, trackers)
Skills and Competencies
- Excellent organisational skills with the ability to manage multiple tasks and priorities effectively
- Ability to work independently within established procedures and escalate issues appropriately
- Strong IT skills including Microsoft Office (Word, Excel, Outlook, Sharepoint)
- Ability to maintain accurate records and track information across multiple systems
- Good interpersonal skills with the ability to work as part of a multidisciplinary team
- Ability to support coordination of multiple studies or projects simultaneously
- Ability to prepare reports or track performance data (e.g. recruitment, study progress)
- Proactive approach with the ability to use initiative within the scope of the role
- Experience using clinical research databases or trial management systems
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website.
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants.
Employer details
Employer name
King's College Hospital NHS Foundation Trust
Address
Coldharbour Works
Denmark Hill
London
SE5 9RS
United Kingdom
Employer's website
https://www.kch.nhs.uk/