Liver Research Administrator

Job overview

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 4 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.

Detailed job description and main 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 taxi’s 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.