Newcastle Clinical Research Facility

Research Support

Research Support

Research support is provided by our administration support team, led by the Operations Manager. They offer a range of services outlined below.

The Operations Manager is responsible for ensuring that a co-ordinated and efficient support service is provided, including staff recruitment and retention.

Clinical trial co-ordination

The Clinical Trial Co-ordinators are responsible for the management and co-ordination of all essential documentation necessary to conduct both commercial and non-commercial clinical research projects.

The Trial Co-ordinators are the first contact for new companies, NuTH Industry Managers and Principal Investigators (PI's) coming into the Facility.

They are responsible for:

  • the registration of new projects, updating and maintenance of the CRF projects database
  • preparation and tracking of submissions for site-specific information to the University and Trust’s Joint Research Office
  • making sure all essential documents are in place before any study commences or participants are recruited
  • presenting and discussing studies for approval by the CRF management group

Prior to a trial, the co-ordinators will liaise with all parties to ensure the smooth start-up of studies. They make sure all regulatory, ethics and other applicable approvals are obtained. They will provide input at the feasibility/design stage of a trial in relation to the Facility’s capabilities and resources, utilising research experience and initiative.

During a trial the co-ordinators will:

  • act as a liaison between the study sponsors, investigators, clinical research nurse team and other departments involved in the conduct of the trial
  • provide guidance and support for PI's and sharing knowledge of best practice and current legislation and guidance
  • prepare, produce and submit reports to management regarding the status of all clinical trials within the Facility
  • receive information and relevant documentation for any amendments to study protocols

To discuss a potential or existing study, contact the Trial Co-ordinators.

Advice on project costing

Costing research can be a complicated procedure. Here at the CRF we offer a comprehensive range of costing methodologies to cover the multitude of possible research areas.

For commercial projects we aim to cost, negotiate and run the project throughout its entirety, ensuring maximum cost recovery in accordance with NIHR guidelines and utilising the NIHR Industry Standard Costing Budget tool.

Non-commercial clinical grant applications should include all costs that are not standard patient care. We can help disseminate this area to ensure grant applications contain all relevant costs and are presented correctly, accurately and in accordance with AcoRD (Attributing the costs of health & social care Research & Development).

For further information please contact our Trial Co-ordinators.

IT services

We have dedicated IT Officers who can provide expert technical support and are available to help with any IT related issues.

Data management

Data Managers form part of the clerical team and work closely with the nursing team, the PI and the sponsor company. Their role includes:

  • co-ordination and checking of clinical data for completeness and accuracy
  • completion of case report forms/data entry
  • management of the clinical site file
  • co-ordination of the sponsor company’s monitoring visits and ensuring trial data is available for monitoring visits
  • co-ordination of patient results and patient information for signature by the PI and filing in the clinical notes
  • resolution of simple data queries and liaison with the clinical team to resolve more detailed queries

Reception services

Two dedicated reception staff provide an efficient and friendly service to patients and visitors, ensuring a high quality of customer care is delivered at all times.

Funded by the National Institute for Health Research:

National Institute for Health Research Clinical Research Facility logo