Do you have experience in setting up, managing and coordinating clinical trials? Would you like to work in a clinical academic environment? Do you have an understanding of trials using medical devices as well as medicinal products?
We are looking for someone with a strong background in managing projects, and working within a clinical trials setting, to become a key member of our research team. You will be responsible for coordinating specific Trauma & Rehabilitation Medicine research projects and clinical trials from set-up and recruitment through to trial closure and analysis. You will provide a wide range of support for the clinical research activities and the senior academic staff. You will also have responsibility for set-up, coordination & oversight of the studies, managing a variety of aspects of the project to ensure it progresses well, recruiting to time and target.
What we offer in return
• 26 days holiday plus approx. 16 Bank Holidays/days that the University is closed by custom (including Christmas) – That’s 42 days a year!
• Generous pension scheme options plus life assurance
• Health and Wellbeing: Discounted staff membership options at The Edge, our state-of-the-art Campus gym, with a pool, sauna, climbing wall, cycle circuit, and sports halls.
• Personal Development: Access to courses run by our Organisational Development & Professional Learning team, and self-development courses including languages, Creative Writing, Wellbeing Therapies and much more.
• Access to on-site childcare, shopping discounts and travel schemes are also available.
And much more!
Main Duties and Responsibilities
With PI/CI delegation, ensuring day-to-day management and coordination of all clinical research administration for the trauma & rehab medicine research portfolios. This includes the IgPro and Phosp-I for long or post-COVID trials; COMPARE and HEARTLOC within Rehab Medicine, and the PliaFX Prime study in trauma, as well as ZNN bactiguard (femur & tibia); InOss, LoBoDe and OSsIRIS;
Offering advice, guidance and management to PIs, Research Fellows, Researchers and Research Nurses during all stages of a clinical trial;
Drafting and coordinating ethics and R&D applications and approvals;
Providing administrative support to PIs in the preparation of grant applications for new research studies;
Ensuring adherence to statutory requirements of the legislation regarding clinical trials of investigational medicinal products and devices, notably the standards of ICH-GCP;
Ensuring that essential documents for all studies are always well maintained;
Working with the senior researchers in order to optimise patient recruitment to each trial, by making available all trial details, including patient information sheets, consent forms, GP letters and clear inclusion and exclusion criteria, to all clinicians and nursing staff;
Identifying amendments needed as the trial progresses and ensuring all members of the project team are aware of amendments;
Working closely with the research nurse and the clinical trials assistant to optimise efficiencies as well as striving to promote a positive team-working environment
These duties provide a framework for the role and should not be regarded as a definitive list. Other reasonable duties may be required consistent with the grade of the post.
To explore the post further or for any queries you may have, please contact:
James Goulding, MSK Trial Management Lead
Email: j.t.r.goulding@leeds.ac.uk
#J-18808-Ljbffr