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Bio-sample coordinator

The biosample coordinator works closely with the trial nurse/practitioner to ensure that required samples are obtained at appropriate time points and processed according to trial lab manual/protocol.

This ensures that at the end of a trial, a high-quality and complete set of samples/sample data is available for analysis. His/her main role is the collection and processing of various trial-related samples and the subsequent safe and appropriate transport of these to central laboratories or elsewhere by ensuring:

  • Good communication with various courier companies to ensure timely pick up of samples and supply of dry ice when necessary
  • Tissue bank staff are aware of trial biopsy collections and the appropriate instructions for processing

Other responsibilities involve:

  • Liaising with histopathology staff at various hospitals to obtain tissue material as part of a trial, or in order to assess eligibility.
  • Ensuring sampling paperwork and airway bills are given to data managers to maintain strict chains of custody for regulated materials (UN3373).
  • Aiding the trial nurse/practitioner by ensuring trial blood tubes and request forms are available for patient collection when needed.
  • Working with phlebotomy staff to ensure appropriate butterfly needles are available for different tube types.
  • Maintenance, servicing and validation of equipment used for processing and storage of trial samples.

Chief Investigator

The overall responsibility of running a research study lies with the Chief Investigator (CI).

Her/his main responsiblities are ensuring that:

  • (S)he has protected time for research activities.
  • The proposed research is successfully completed.
  • The study is funded and conducted in line with all applicable regulations and guidelines.
  • Agreed milestones and timelines are met.
  • The trial team receives enough support to reach the trial milestones, within the allocated budget.

Data Manager

The data manager works closely with the trial coordinator to ensure that at the end of a trial, a high-quality and complete set of data is available for analysis.

His/her main role is the collection, verification and organisation of trial-related data in various forms and the subsequent transferral of that information to paper documents and electronic databases. In practice, the data manager:

  • Checks case report forms returned from sites and raises queries for missing/discrepant information using data querying guidelines.
  • When queries are returned, he/she updates the database accordingly and follows-up with the site if there are outstanding queries.

Other responsibilities can involve:

  • Maintaining trial documentation.
  • Helping to prepare reports & publications.
  • Assisting with the development & testing of databases.
  • Coordinating the transfer of biological samples.

Finance Administrator

The Finance Administrator is responsible for providing comprehensive financial assistance to all CCTC staff in relation to the set up and conduct of research in the unit.

They will respond to all financial queries pertaining to invoices, budget setting and be proactive in their analysis of the finance of the department.

They will have autonomy to continually improve and develop the service and the concomitant relations with pharmaceutical companies wishing to carry out research with the unit.

HR Administrator

The HR Administrator is responsible for overseeing the recruitment and selection process from vacancy authorisation through to appointment, preparing VA documents, organising interviews and requesting contract paperwork once pre-employment checks are complete.

The HR Administrator is also the first point of contact for HR and payroll queries. All Personnel matters are dealt with by the HR Administrator alongside line managers, including; annual appraisals, contract extensions, and all types of leave.

Pharmacist

The pharmacist’s main role is to provide advice on the use of Investigational Medicinal Products (IMPs) to ensure that drug presentation, supply, storage, preparation and distribution meet current legal and professional requirements.

The pharmacist will also ensure that IMPs are managed and dispensed in accordance with the protocol and maintain documentation to GCP standards for all aspects of product handling and accountability.

In particular, the pharmacist can:

  • Advise on regulations and guidelines on good clinical practice and good manufacturing practice.
  • Advise on health and safety aspects of drug handling, dispensing and reconstitution ensuring that IMPs are appropriate for use and are procured, handled, stored and used safely and correctly.
  • Monitor adherence to pharmaceutical criteria, such as previous or concurrent drug treatment.
  • Provide Trust's clinical risk assessments of individual clinical trials.
  • Provide pharmacy related sections for protocol, CRFs, IRAS, pharmacy manual etc.

Programmer

The programmer’s primary role is to ensure the capture of robust and reliable electronic data that answers the research question.

To this end (s)he works closely with the trial team and facilitates the process of translating the data requirements into a robust database. Mainly, the programmer will:

  • Provide input on the design of CRFs based on specifications given by the trial team.
  • Design edit checks and validations to ensure the correctness of data, running bespoke processes as required (for example providing scripts to ensure data quality) and querying and exporting data in an agreed format for use by the statistician and trial team.
  • Fulfil other IT-related requirements for the department, such as creating bespoke applications and the extraction, transformation and loading of data as required, for example, combining data from multiple trials into one dataset for analysis.

QA Manager

The Quality Assurance Manager is responsible oversight of the activities required to maintain and develop systems for assuring the quality of facilities, procedures, processes and data, and for providing assurance of the legal and regulatory compliance status of Cancer Trial work and translational research, both in clinical and laboratory settings.

Additional responsibilities include:

  • Conducting an independent auditing programme, to inform management of the regulatory status of Trials/Studies and to identify areas of regulatory risk.
  • Oversight of validation procedures.
  • Provide quality assurance training for staff, plus guidance and advice on all aspects of compliance.

Research Nurse

The research nurse/practitioner works closely with the multidisciplinary team and the data manager to ensure the smooth running of a trial with the patient being at the centre of all the care that is given.

The main parts of the role are to ensure a high standard of care based on the assessment, development, implementation and evaluation of programmes of care, identifying priorities and realistic goals involving patients, their carers and the multi-professional team.

Other responsibilities include:

  • Ensuring patients / carers are provided with written information relevant to the trial they are considering entering.
  • Ensuring patients / carers are given the opportunity to discuss the trial with the clinicians initially and as required.
  • Offering counselling / support and further information to patients / carers during the period preceding entry to a trial and for the duration of the trial and are the first point of contact if there are any issues.
  • Ensuring that data capture and entry is accurate and complete.
  • Attending patients admitted to the wards for monitoring and assessment during trials.
  • Taking blood samples, centrifuging and separating serum, package and despatch as per trial protocols.

 

The role also involves working closely with Principal Investigators responsible for a specific trial, as well as other clinical, nursing and support services staff involved in the conduct of the trial, for the welfare of the trial and for the patients involved. We liaise closely with trial sponsors and CRAs to ensure successful conduct of trials. We also promote general health education and facilitate specific teaching of patients and their carers to encourage optimum self-care on discharge where appropriate. As a research team we also ensure that our practice is in line with recommendations of ICH Good Clinical Practice Guidelines.

Statistician

The statistician may be involved from the initial concept until publication.

The statistician’s main role is to:

  • Provide advice on outcome measure definition, study design and sample size calculations
  • Support protocol/Case Report Form (CRF) development
  • Develop the statistical analysis plan
  • Perform interim analyses and final analyses
  • Support the CI to draft the manuscript especially for the methods and results sections.

Trial Coordinator

Trial coordinator works closely with the CI and the Trial Management Group to conduct the study following all applicable legislation and to ensure milestones are reached.

The trial coordinator’s role is essential to help the CI deliver a high quality study by pro-actively ensuring that all parties are aware of research requirements and their associated timelines.

Typically, a trial coordinator will liaise with all staff groups to:

  • Write protocol, patient information sheet, consent form and other related documents.
  • Complete IRAS applications and submit to REC/MHRA/R&D sites.
  • Organise IMP supply.
  • Design CRF and database.
  • Organise and initiate sites.
  • Liaise with sites on a regular basis.
  • Provide data management (central data collection, entry and cleaning).
  • Deal with pharmacovigilance.
  • Write all regulatory reports.
  • Perform site close out.
  • Organise the archiving of essential documents.

Trial Coordinator Team Lead

The team lead manages and provides direction to the team members to ensure delivery of a high quality service (delivery of trial coordination targets within time and budget).

They are the main point of contact for investigators who wish to use the CCTC’s coordination team to run Trust-sponsored trials/studies. The coordination team lead will support Chief Investigators (CIs) to develop grant applications, ensure that all appropriate parties are involved to enable timely submissions, provide costs for the specific project.

(S)he will recruit, provide training to trial coordination staff to ensure that the trial is run following all relevant guidelines/legislation/SOPs, and manage internal staff resources to ensure an effective use of the team. Where investigators need short-term solutions (e.g. staff time to enter data), the core coordination team may offer help if there is capacity.

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