Share this Job

Clinical Trials Administrator

Requisition ID:  21621
Location: 

Newcastle, GB

Contract Type:  Open Ended
Working Pattern:  Full Time
Posted Date:  04-Aug-2022

 

We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.

 

What’s in it for you? 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.

 

Newcastle is an inclusive global University community where everyone is treated with dignity and respect.  As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

 

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains colleagues from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from everybody, regardless of race, sex, ethnicity, religion, nationality, sexual orientation, age, disability, gender identity, marital status/civil partnership, pregnancy and maternity, as well as being open to flexible working practices.

 

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

 

Closing Date: 28 August 2022

 

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.

 

To read more about how we make a difference please click here.

 

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.

 

If this is you, please contact Dr Sonya Collins (sonya.collins@newcastle.ac.uk) or Dr Eva Holstein (eva.holstein@newcastle.ac.uk). 


Key Accountabilities
•    Assist with the set-up of studies managed through NCTU, including assisting the Trial Manager with the production and collation of documentation required for compliance with legislative frameworks and applications for Clinical Trials Authorisation, Ethical Opinion and R&D approval as well as sending out all documents required by sites to complete the set-up process, collating all returned core documents and checking for completeness.  Set-up site initiation calls and prepare the site file for site activation sign off
•    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

 

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 
•    Good working knowledge of MS Office applications
•       Ability to liaise closely with colleagues at all levels, both internal and external 

 

Attributes and Behaviour

•    Enthusiastic, innovative approach to challenges
•    Ability to work to deadlines
•    Ability to organise own workload, with minimum supervision and work effectively as part of a team
•    Demonstrated commitment to ongoing personal development and training
•    Willingness to travel outside of the Newcastle area and work from both NCTU and James Cook Hospital

 

Qualifications

•    A Levels/NVQ Level 3 or equivalent, or significant relevant experience of working in clinical research
 

The University holds a silver Athena SWAN award in recognition of our good employment practices for the advancement of gender equality. The University also holds the HR Excellence in Research award for our work to support the career development of our researchers, and is a member of the Euraxess initiative supporting researchers in Europe.

 

Requisition ID: 21621