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Clinical Trial Administrator

Requisition ID:  8602
Location: 

Newcastle, GB

Contract Type:  Open Ended
Working Pattern:  Full Time
Posted Date:  03-Jun-2021

 

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.

 

Salary: £25,941.00 - £30,046.00 

Closing Date: 24 June 2021

 

The Role

 

We have an exciting opportunity for 2 FTE Clinical Trials Administrators to support to join our successful UKCRC registered Clinical Trials Unit. The Clinical Trials Administrator will be part of the UKCRC registered Newcastle Clinical Trials Unit (NCTU). The post holder will support the activities of NCTU, working to ensure that clinical trials are managed in line with sponsor, regulatory and research governance requirements. There are currently approximately 50 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally and from two main hubs in Newcastle and South Tees. Chief Investigators, Principal Investigators and Co-Investigators are located throughout and beyond the University. You will be expected to work at both sites depending on the needs of individual trials and NCTU.  It is likely that you will be working on a portfolio of between 2 and 4 trials at any one time, though this will vary. The trials will be of varying types of intervention and may be single or multi-centre.

 

You will work within a multi-disciplinary team including Trial and Data Managers to ensure that clinical trials are managed in line with sponsor, regulatory and research governance requirements. This is an exceptional opportunity for the right individuals to join our team.  You should be an enthusiastic and motivated individual with strong administration, communication and organisational skills, as well as excellent attention to detail.  A working knowledge of Good Clinical Practice and experience of project planning and management are desirable for this post. You will support trials in both Newcastle and in our hub at The James Cook University Hospital. You will work at these sites depending on the needs of individual trials and NCTU. Part time working would be considered. 

 

Enquiries about this post can be made through: Dr Sonya Carnell (Senior Trial Manager) sonya.carnell@newcastle.ac.uk or Dr Eva Holstein (Clinical Trial Administrator) eva.holstein@newcastle.ac.uk

 

Further details about NCTU can be found via the following link:  https://www.ncl.ac.uk/nctu/about/

 

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 (Essential)

 

Knowledge, Skills and Experience

  • Excellent oral and written communication skills
  • Strong team working skills
  • Critical and intelligent attention to detail and high standards of accuracy
  • Significant administrative experience
  • Experience of working within a clinical and/or research environment
  • Good working knowledge of MS Office applications
  • Ability to liaise closely with staff at all levels, both internal and external (e.g. other Faculty staff, NHS staff and trial site staff)
  • A working knowledge of ICH GCP (Desirable)
  • Experience of project planning and management (Desirable)

 

Attributes and Behaviour

  • Enthusiastic, innovative approach to challenges
  • Ability to work to deadlines
  • Ability to organise own workload, with minimum supervision
  • Flexibility with respect to working hours
  • Willingness to travel outside of the Newcastle area
  • Must be able to work from both NCTU and James Cook Hospital
  • Demonstrated commitment to ongoing personal development and training (Desirable)

 

Qualifications

  • A Levels/NVQ Level 3 or equivalent, or significant relevant experience of working in clinical research
  • Formal training in Good Clinical Practice (Desirable)

 

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains staff 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.

 

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: 8602