Clinical Trials Administrator

3 weeks ago

Oxford, United Kingdom Oxford University Hospitals NHS Foundation Trust Full time

Band 4 FULL TIME

This is an exciting opportunity to work within our vibrant and enthusiastic Clinical Trials Research team. We currently have a varied portfolio of both commercial and non-commercial studies in Multiple Sclerosis, NMO and other neurological diseases.

This position would be a good starting point for someone interested in pursuing a career in Clinical Trials Administration.

Based at the John Radcliffe Hospital, the post-holder will assist in the day to day running of the MS Trials office. You will work collaboratively with the vibrant and enthusiastic clinical studies teams and the wider multi-disciplinary teams. You will need to gain basic training in national research guidelines in order to contribute to the smooth-running of the office, and there is scope to become involved in set up of commercial and non-commercial trials, and to develop finance skills. This post would suit someone with a background in office administration, but equally it would suit someone who is interested in a career in Clinical Trials Administration. Strong IT skills would be an advantage.

The National Institute for Health Research (NIHR) is funded through the Department of Health to improve the health and wealth of the nation through research.

**The CRN**: Thames Valley and South Midlands is one of 15 local Clinical Research Networks in the NIHR Clinical Research Network (NIHR CRN). The NIHR CRN is the clinical research delivery arm of the NHS in England, tasked with supporting the rapid set-up and effective conduct of studies, so that researchers can gather the robust evidence needed to improve treatments for NHS patients. These local Networks drive clinical research delivery performance across the locality, and champion the role of clinical research in the NHS at every level.

**The CRN**: Thames Valley and South Midlands is hosted by Oxford University Hospitals NHS Foundation Trust and works in partnership with local NHS Trusts to fulfil the aims of the NIHR CRN. The CRN: Thames Valley and South Midlands supports clinical research in Oxfordshire, Buckinghamshire, Berkshire and Milton Keynes.

Assist with running of clinics
- Patient appointment letters, maintenance of clinic calendars, liaising with external departments to plan external appointments, GP follow up letters, processing of patient information sheets. The post-holder will need to communicate effectively with patients and members of our extended teams, to ensure smooth running of clinics.

Assist with the efficient and timely set up of clinical trials; including:

- Costings.
- Contracts.
- Liaising with pharmaceutical companies to ensure all trial related paperwork is in order.
- Assist with the tracking and raising of invoices, preparing purchase orders, processing of patient travel claims.
- Assist with financial planning tasks and projections.
- Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
- Assist with preparation for audit and inspections within assigned teams.
- General trial-related communication in accordance with the Data Protection Act.
- Act as a point of contact for the R&D team, study sponsors, and research organisations, communicating directly with them regarding monitoring visits and other enquiries relevant to trial set up and general trial conduct.
- Maintain investigator site files in accordance with ICH-GCP and Trust SOPs.
- Assist in the process of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
- Provide administrative support to Principal Investigators.
- Ensure collection and return of clinical case notes for all patients, so that these are available as needed, for patient visits, monitoring and audit purposes.
- Arrange team and trial related meetings as required, producing minutes in a timely manner. Ensure that data is available and up to date for any meetings related to a clinical trial.
- Attend project related meetings to convey the relevant information to the study team.
- Assist with preparation for audit and inspections within the Neurology team.
- Assist with trial document archiving by following the Trust’s archiving guidelines.
- Support the team in the preparation of conferences and patient days.

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