Clinical Trial Administrator

1 week ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

Salary:
£27,131 to £28,762 with progression to £31,411 per annum

Newcastle University is a great place to work, with excellent benefits.

We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.


Closing Date: 26 February 2023

The Role


Newcastle Clinical Trials Unit (NCTU) is a thriving registered academic unit, working in collaboration with investigators to design and deliver clinical trials answering important clinical questions, whose findings bring substantial impact to patients and the NHS.

We are delighted to share with you an exciting opportunity for a Clinical Trials Administrator within our successful and expanding UKCRC Registered Clinical Trials Unit.


You will work within a multi-disciplinary team including Trial and Data Managers to ensure that clinical trials are delivered in line with sponsor, regulatory and research governance requirements.


We currently have approximately 40 active trials and studies, and work with multiple trial sponsors locally, nationally and internationally from two hubs in Newcastle (main hub) and South Tees.

You may be expected to work at both sites depending on the needs of individual trials and NCTU.


You should be an enthusiastic and motivated individual with strong administration, communication and organisational skills, as well as excellent attention to detail.


The role is full time, but we are keen to hear from people who may wish to discuss flexible working arrangements.

We can offer a blended approach to home and office working.

Key Accountabilities
Support the participating study sites, maintaining regular contact with site personnel to check on trial progress and trial supplies. Send out additional and updated trial supplies and documents.

Deal with routine trial queries, passing non-routine queries to the appropriate trial management staff or other trial professionals where appropriate, ensuring that any issues are resolved within a reasonable timeframe.

Use initiative to tackle any practical difficulties reported by sites under the guidance of the Senior Trial Manager and Trial Manager
Work with the Data Manager to maintain systems to track the progress of the trial such as tracking accruals at different sites, liaising with site leads for up to date information and logging this on the trial database; and tracking the return of screening logs, Case Report Forms (CRF) and patient questionnaires, check completed CRF's and questionnaires, raise queries and rectify errors
Process Serious Adverse Events (SAE) that are reported, recording the information into the study SAE logs.

Enter SAE data into trial databases, track and resolve any queries from Clinical Coordinators, study sites, Sponsor and regulatory authorities where requested.

Follow the event up until resolution of the event and queries
Support the effective administration of trial steering committees, data monitoring committees and internal trial management meetings by preparing timetables and agendas; arrange printing of meeting documents; taking minutes in meetings and chasing resulting actions
Assist with the close down of studies by setting up close down visits and teleconferences, preparing and tracking close down checklists, tracking Patient Reported Outcomes and preparing the Trial Master file for archiving and arranging the archiving process
Provide cover for the Trial Manager as required and requested during any absences. On these occasions, the post-holder will monitor trial progress closely, providing weekly reports on progress to the Senior Trial Manager
Arrange travel and accommodation for NCTU staff, contractors, visitors and meeting attendees as requested by the Trial Manager. Arrange conference calls as requested
Plan and organise mailshots and newsletters, contact suppliers for quotes and details of services provided. Assist with the design and organisation of promotional material for NCTU studies. Access the effectiveness of previously used items (calendars, stationery, posters etc.) and develop ideas for new material
Assist in review of standard operating procedures relating to the Trial Administration role. Train and supervise admin staff involved in supporting trials and data management, on the rules and procedures to be used
Take responsibility for identifying own learning needs, including participating in regular Performance and Development Review meetings with a Trial Manager or Data Manager to set educational and professional development goals and objectives and chart progress in relation to these

The Person (Essential)

Knowledge, Skills and Experience
Experience of working within a clinical and/or research environment
Critical and intelligent attention to detail and high standards of accuracy
Significant administrative support experience
Excellent oral and written communication
Ability to liaise closely with colleagues at all levels, both internal and externa

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