Job Description
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Overview
This is a joint post between the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust (STH), funded by a £4M+ Yorkshire Cancer Research Transformative Capital Investment as part of the Sheffield Platform for Imaging Research in Oncology (SPIRO). The postholder will be responsible for the effective and efficient management of clinical cancer imaging research studies across multiple modalities (MRI, PET, and CT). They will hold an honorary STH contract and will be trained by STH in study set-up, IRAS applications, and governance processes, working with the STH Clinical Research and Innovation Office (CRIO) research coordinator team approximately two days per week. The postholder will coordinate between the University’s imaging facilities, Sheffield Teaching Hospitals, Weston Park Cancer Centre, and other clinical partners to facilitate the delivery of high-quality imaging research studies. They will be responsible for research governance, including ensuring adherence to national and international regulatory frameworks, supporting regulatory submissions (e.g. IRAS, HRA and MHRA)as applicable, and contributing to capacity and capability assessments for SPIRO studies. The role also encompasses patient recruitment and management, coordination of imaging appointments across multiple modalities, and liaison with a wide range of stakeholders.
Main duties and responsibilities
* Coordinate and manage clinical imaging research studies across MRI, PET, and CT modalities, ensuring compliance with study protocols and Good Clinical Practice (GCP). Liaise with Principal Investigators, clinical teams, support services and research staff to ensure efficient study delivery and adherence to timelines.
* Manage study documentation, including ethics applications, amendments, regulatory submissions, and IRAS forms in collaboration with the STH Clinical Research and Innovation Office (CRIO) and University research governance teams.
* Ensure adherence to Research Governance in accordance with national and international regulatory frameworks including the UK Policy Framework for Health and Social Care Research, ICH GCP, and Medicines for Human Use (Clinical Trials) Regulations 2004.
* Advise and support investigators with grant funding bodies and submissions to the HRA, including IRAS forms.
* Coordinate study set-up meetings and confirm roles and responsibilities for, both pre-award and post-award activities.
* Ensure the necessary REC, HRA and other regulatory approvals (e.g. MHRA, ARSAC),local approvals, indemnity and contracting are in place in order to issue Research Governance Confirmation of Capacity and Capability.
* Support patient recruitment activities for SPIRO imaging studies by coordinating with clinical research teams who undertake screening and consent. Manage participant scheduling, maintain recruitment databases, and act as a point of contact
* for research participants regarding imaging appointments and practical arrangements.
* Coordinate imaging appointments across multiple modalities, optimising scanner utilisation and minimising patient burden. Manage patient confidentiality and data according to University Policy, Equality Act and GDPR.
* Contribute to the monitoring, audit and quality assurance procedures required of the STH CRIO, including for regulatory inspection. Contribute to the performance management of NIHR portfolio studies and to STH CRIO education programmes.
* Responsible for finances related to research studies including purchasing, liaising with suppliers, and research invoicing. Liaise with Finance Administrators to ensure resources are fully costed and research budgets are well managed.
* Support Pharmacovigilance responsibilities for both sponsored and hosted studies. xsngvjr
* Carry out other duties, commensurate with the grade and remit of the post
Criteria
* Educated to masters level in health-related or biomedical sciences, or registered Nurse/AHP qualification and research qualification, or equivalent experience-Essential
* Experience of coordinating clinical or biomedical research studies in an NHS, academic, or commercial environment-Essential
* Knowledge of research legislation including research governance, GCP, the UK Policy Framework for Health and Social Care Research, HRA governance arrangements, and Medicines for Human Use Regulations-Essential
* Knowledge of ethics and governance processes related to clinical research, including IRAS submissions and HRA approvals-Essential
* Experience of coordinating pharmaceutical research or grant-funded research studies that have received ethics approval and require recruitment of patients-Essential
* Knowledge of the research process and research methods applicable to health settings, including NIHR research strategy-Essential
* Excellent interpersonal skills, ability to work to a high degree of accuracy with attention to detail, and proven ability to build and maintain relationships both internally and externally-Essential
* Highly organised with the ability to assess and organise resources, plan and progress work activities, and act with confidentiality, discretion and sensitivity-Essential
* Understanding of medical imaging modalities (MRI, PET, CT) and their application in oncology research-Desirable
* Experience of working in oncology research or with cancer patients. Experience of clinical research audit, monitoring and inspection-Desirable