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SalarySalary: £33,966 to £36,024 with progression to £44,263 per annum
Newcastle University is a great place to work, with excellent . 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: 04 April 2024
The Role
The post is within the UK CRC registered Newcastle Clinical Trials Unit (NCTU). This is a multi-faceted post requiring you to set-up, manage, co-ordinate and support clinical trials to ensure that they are conducted in line with sponsor, regulatory and research governance requirements. You will work as part of a multidisciplinary team including Senior Trial Managers, Clinical Trial Administrators, Statisticians, Data Managers, Chief Investigators and members of Trial Management Groups and other stakeholders to ensure successful completion of trials.
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. There will be opportunity to input academically and operationally to trial development and to have this recognised in publications.
This is a full-time, open-ended post.
Further information can be obtained by contacting Sarah Dunn at ( ) or Nicola Goudie ( )
Find out more about the Faculty of Medical Sciences here:
Find out more about our Research Institutes here:
As part of our commitment to career development for research colleagues, the University has developed 3 levels of research role profiles. These profiles set out firstly the generic competences and responsibilities expected of role holders at each level and secondly the general qualifications and experiences needed for entry at a particular level.
Key Accountabilities
- Working as part of a trial team, provide day to day management of clinical trials undertaken by Newcastle Clinical Trials Unit
- Provide advice to investigators and trial staff to ensure compliance with legislative frameworks
- Demonstrate in-depth knowledge of individual trials, alongside knowledge of the relevant therapeutic area
- Work with all members of the trial team (including the Chief Investigator, Senior Trial Manager, Data Manager and Statistician) to ensure all processes throughout the trial lifecycle are completed within agreed trial time-lines, and any subsequently agreed plans
- Work with the Data Management team to ensure that data cleaning procedures and quality controls produce trial data which is accurate, complete and timely
- Proactively identify any issues within individual trials, appropriately escalating these, including to Senior Trial Managers, finding and implementing solutions as required (including: recruitment; protocol deviations; serious breaches)
- Set-up clinical trials, undertaken by NCTU, including contributing to the development of the trial protocol and other trial documentation, required for compliance with legislative frameworks
- Complete and manage applications for Clinical Trial Authorisation, Ethical Opinion, HRA approval and other approvals as required
- Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials, and the General Data Protection Regulation
- Work with the grants and contracts team, Sponsor, Senior Trial Manager and others, as appropriate, to ensure that contracts and agreements are in place for individual trials
- Perform site initiation visits and train site personnel in trial protocols and procedures during the trial
- Monitor clinical trials at trial sites, including measuring adherence to the protocol and standard operating procedures and applicable regulatory requirements
- Close the trial, including completion of applicable regulatory reporting requirements and contribute to the funder report and wider dissemination of trial findings
- Work as part of the Trial Manager team and with others in NCTU (including QA) to ensure common ways of working and best practice in clinical trial management
- Inform the development and implement the Unit’s Standard Operating Procedures (SOP’s) and develop trial-specific SOP’s
- Prepare routine progress reports and ad hoc reports to funding bodies, sponsors, regulatory authorities, research ethics committees, Trust R&D departments etc.
- Coordinate Trial Steering Committee, Data Monitoring and Ethics Committee and Trial Management Group (TMG) meetings
- Chair TMG meetings and associated trial meetings
- Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
- Make independent decisions and to advise and work with others on the trial.
- Take responsibility for identifying your own learning needs, including participating in regular Personal Development Review meetings with a Senior Trial Manager to set development goals and objectives and chart progress in relation to these.
- Liaise with external organisations regularly including NHS Trusts, Universities, funding bodies and UK CRC registered Trial Unit working groups
- Develop close and effective working relationships with PI’s, CI’s, CTU, NIHR RDS and other colleagues and representative of study sponsors to ensure compliance and provide support in this area
- Represent the unit at external events as appropriate
- Undertake other reasonable duties or responsibilities appropriate to the grade as requested from time to time by NCTU
Knowledge, Skills and Experience
- Understanding the principles of management of clinical trials, including the role of a Trial Manager in the lifecycle of a trial
- Knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health and Social Care Research
- A sound knowledge of the principles of Good Clinical Practice
- An understanding of the process for making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
- Good working knowledge of MS Office applications
- Experience of project planning and management
- Excellent interpersonal, oral and written communication skills
- Effective report writing and presentation skills
- Ability to make independent decisions and to work independently, alongside excellent team working skills
- Ability to work to deadlines and organise own workload
- Excellent organisational and administrative skills
- Production of high quality documents and reports
- Appropriately handle confidential and sensitive information
- Experience in the management of clinical trials, at sponsor/project management level
- Experience of performing Site Initiation Visits
- Experience of central and site-based monitoring
- Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
- Experience of Chairing meetings
- Enthusiastic, innovative and proactive approach to work; able to think critically and have the ability to rapidly assess and link information
- Demonstrated commitment to ongoing personal development and training
- Attention to detail
- Flexibility with respect to working hours
- Willingness to travel outside of the Newcastle and South Tees areas
- 1st Degree (or equivalent professional qualification and/or experience) in a relevant discipline
- Higher degree in a relevant discipline
We are committed to being a fully inclusive 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 of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.
At Newcastle University we hold a silver award in recognition of our good employment practices for the advancement of gender equality. We also hold a Bronze award in recognition of our work towards tackling race inequality in higher education REC. We are a employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.
In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Requisition ID: 26798
