To be the main point of contact and support for the SYMPHONY trial being led by clinical academics in the School of Cardiovascular and Metabolic Health. This post will involve close working with the Head of Clinical Trials for the Heart Failure Group, other trial Project Managers and administrative staff, and College Project Coordinators, College Research Support Office and University Services to ensure that effective communication takes place, and a seamless research management support service is delivered.
Main Duties and Responsibilities
1. Provide pre- and post-award advice and support for the SYMPHONY global trial, TARTAN in Scotland, and other heart failure projects as required. This will include coordination of application for NHS research ethical committee and MHRA clinical trial approval, milestone planning and post-award reporting and financial management.
2. Work with colleagues in Robertson Centre for Biostatistics to coordinate the development of the electronic case report form, its testing and approval for the SYMPHONY trial.
3. Coordinate the ongoing assessment of risk and documentation of such activities with the NHS Greater Glasgow and Clyde and University of Glasgow sponsor teams of this investigational medicinal product trial.
4. Manage the preparation of the Chief investigator Trial Master File and other trial documentation and maintain this according to MHRA and GCP regulations.
5. Coordinate the sponsor Green for Go process required to open sites including planning of site initiation visits, provision and documentation of training for all staff and coordination of site files.
6. Provide post award support, including that for ethics applications, project coordination, portfolio management, financial management and project change processes and control.
7. Support funder and other audits, ensuring adequate audit records are maintained and attend meetings with auditors, as required.
8. Provide management information and analyse data to inform both day to day decision making and also college research budgeting and strategy. Support the input to future College submissions to the Research Excellence Framework REF.
9. Be actively involved in appropriate cross-college collaborative working to build networks, share best practice, develop web-based resources and provide training.
10. In liaison with college HR and Principal Investigators, assist in the workforce planning across different bids and awards to maximise the efficient use of research teams and minimise staffing disruption.
A1 Scottish Credit and Qualification Framework level 12 (PhD) or equivalent professional and/or teaching experience in a similar or related role.
A2 Knowledge and understanding of clinical research data integrity, patient confidentiality and its importance
A4 An understanding of research grant preparation and application processes including costing, for both internal University Of Glasgow and external partners (i.e. commercial, charity and NHS)
A5 Extensive knowledge of research grant activities including adhering to funder guidelines, foreign currency awards, grant reporting and end of grant management.
B1 Knowledge of the Research Ethics approval process and MHRA applications process for clinical trial authorisations for medical device and CTIMPs.
B2 Knowledge of Good Clinical Practice and regulatory framework which governs clinical research
Knowledge and Skills
C1 Project management – both short-term deadlines and longer-term involving multiple conflicting deadlines and coordination across multiple organisational units
C2 Ability to network effectively
C3 Ability to exercise initiative and work independently but also as part of a multidisciplinary team
C4 Ability to work flexibly and adapt to changing environments
C5 High level of influencing and negotiating skills
C6 Excellent oral and written communication skills with the ability to communicate at all levels
C7 Ability to interpret complex guidelines and prepare reports and budgets in line with the requirements set out
C8 Experience of interrogating and maintaining databases, processing, analysing and presenting data and in particular experience of finance systems in higher education.
C9 Experience of completing grant applications including coordinating internal and external costs and approvals for research council and commercial funders.
E1 Significant experience of relevant research project management in a similar or related role
E2 Significant experience if University grant management and finance systems (e.g. aggresso or similar)
E3 Experience of successfully overseeing the work of staff, including providing training where appropriate.
E4 Experience of meeting milestones, deadlines and meeting deliverables.
All research and related activities, including grants, donations, clinical trials, contract research, consultancy and commercialisation are required to be managed through the University's relevant processes (e.g. contractual and financial), in accordance with the University Court's policies.
Terms and Conditions
Salary will be Grade 7, £37,474 - £42,155 per annum.
This post is full time and fixed term until 30 September 2025.
As part of Team UofG you will be a member of a world changing, inclusive community, which values ambition, excellence, integrity and curiosity.
As a valued member of our team, you can expect:
1 A warm welcoming and engaging organisational culture, where your talents are developed and nurtured, and success is celebrated and shared.
2 An excellent employment package with generous terms and conditions including 41 days of leave for full time staff, pension - pensions handbook https: // www. gla.ac.uk/myglasgow/payandpensions/pensions/, benefits and discount packages.
3 A flexible approach to working.
4 A commitment to support your health and wellbeing https: // www. gla.ac.uk/myglasgow/staff/healthwellbeing/.
We believe that we can only reach our full potential through the talents of all. Equality, diversity and inclusion are at the heart of our values. Applications are particularly welcome from across our communities and in particular people from the Black, Asian and Minority Ethnic (BAME) community, and other protected characteristics who are under-represented within the University. Read more on how the University promotes and embeds all aspects of equality and diversity within our community https: // www. gla.ac.uk/myglasgow/humanresources/equalitydiversity/.
We endorse the principles of Athena Swan https: // www. gla.ac.uk/myglasgow/humanresources/equalitydiversity/athenaswan/ and hold bronze, silver and gold awards across the University.
We are investing in our organisation, and we will invest in you too. Please visit our website https: // www. gla.ac.uk/explore/jobs/ for more information.
Vacancy Ref : 102731 Close Date : 01-Dec-2022 23:45