We are looking for an outstanding individual to help lead co-ordination of clinical trials within the IoPPN, one of the world’s leading research centres for neurodevelopmental disorders.
The role will be responsible for leading on clinical trials, funded via the IMI AIMS-2-TRIALS Project and other funders such as NIH, or industry-sponsored trials. AIMS-2-TRIALS is the world-wide largest project focused on the identification and validation of biomarkers for Autism Spectrum Disorder and the testing of new treatments.
The successful candidate will have overall management responsibility of the clinical trials operations which includes taking care of regulatory aspects and ethics applications, site management, resources management, staff training and monitoring progress to ensure key project deliverables. They will be liaising with UK/European/International and industry partners. He/she will enable systems and processes for the smooth running of the clinical trials within the department. The post holder will draw on support from other experts and the clinical trials infrastructure at IoPPN and King’s health partners, including a clinical trials office, a clinical research facility, and a clinical trials unit.
In collaboration with senior staff, the post holder will help to coordinate the clinical trials with input from research staff, develop additional funding applications, and consolidate the project outputs. The post holder may be required to line manage research workers and/or student projects.
This post will be offered on an a fixed-term contract until 31st May 2023 with the likelihood of an extension.
This is a full-time post (100% full-time equivalent)
• To be responsible for the day-to-day management and co-ordination of clinical trials
• Assist Professor Strydom (and other co-PIs) in leading on applications for initial approvals and ensure on-going adherence to the requirements of the relevant regulatory bodies and submit amendments as appropriate
• Monitor participant recruitment; and designing innovative solutions to any road blocks that may emerge
• Implement the principles of the Good Clinical Practice (ICH-GCP) guidelines for clinical trials and ensure that all study personnel work according to them.
• Line management of research workers, planning and prioritising of schedules
• Ensure timely reports for funding and regulatory bodies
• To organise, and attend where possible, face to face meetings and regular tele- or videoconferences with trial sites, and any extra-ordinary meetings as they arise.
• To track trial progress including tasks, deliverables and milestones
• Maintain the clinical trial ISFs and TMFs
• Assist with the preparation and conduct of monitoring visits
• Monitor contractual and budget arrangements (including the development of new contracts) with outside organisations as required
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Essential criteria
1.Graduate qualification in relevant area (pharmacology, biological sciences, neuroscience, research or trial methodology, etc)
2.;Experience of the conduct and project management aspects of CTIMPs gained in multi-centre, phase II and/or phase III, randomised trials
3.Awareness of the EU Clinical Trials Directive, UK Clinical Trials regulations, principals of Good Clinical Practice, General Data Protection Regulations, UK Policy Framework for Health and Social Care Research
4.Evidence of preparing regulatory and ethics submissions and amending protocols, participant information sheets, electronic databases and other relevant trial management documentation
5. Ability of writing complex reports
6.Experience of database management
7.Accuracy and attention to detail
8.Thoroughly computer literate and experienced in the use of Microsoft applications
9.Ability to work to own initiatives as well as being part of a team, prioritise workload in order to meet deadlines and targets and deal with constraints that may be outside of their control
Desirable criteria
Find further information and where to apply here.
Prof Andre Strydom, andre.strydom@kcl.ac.uk
