Trial Administrator

The Trial Administrator provides an effective research management service for OUH's Haematology research programme. Working closely with consultants, nursing and research teams across the Haematology Trials Unit (HTU), the post holder will administer a rolling portfolio of clinical studies to ensure research is conducted to a high standard and delivered to time and target. The role is predominantly office/computer-based and operates a communications hub with daily contact across multidisciplinary teams and external partners. Trial Administrator will manage several studies of varying complexity across the full lifecycle, including set-up, amendment, maintenance, close-out and archiving, in line with UK GCP and applicable regulations. The post holder will follow OUH procedures and contribute to internal and external quality assurance activities., · Prepare and produce submissions, documents and reports to secure approvals, contracts and funding required to initiate research projects. · Maintain approved projects through their lifecycle, including administering amendments, annual reports, close-out and archiving. · Act as focal point for communications; liaise with Chief/Principal Investigators and multidisciplinary study teams to support smooth project delivery to agreed timelines. This is not an exhaustive description of the role; please refer to the full job description for complete details · Prioritise, monitor and report progress; identify risks to trial delivery and coordinate timely mitigation/escalation. · Ensure robust document control, including set-up and maintenance of Investigator Site Files/Trial Master File sections and retention of essential correspondence to reconstruct the conduct of the study. · Work to Standard Operating Procedures (SOPs), written instructions, templates and checklists, and assist with drafting/reviewing administrative procedures as required., · Prepare and produce submissions, documents and reports to secure approvals, contracts and funding required to initiate research projects. · Maintain approved projects through their lifecycle, including administering amendments, annual reports, close-out and archiving. · Act as focal point for communications; liaise with Chief/Principal Investigators and multidisciplinary study teams to support smooth project delivery to agreed timelines. · Prioritise, monitor and report progress; identify risks to trial delivery and coordinate timely mitigation/escalation. · Ensure robust document control, including set-up and maintenance of Investigator Site Files/Trial Master File sections and retention of essential correspondence to reconstruct the conduct of the study. · Work to Standard Operating Procedures (SOPs), written instructions, templates and checklists, and assist with drafting/reviewing administrative procedures as required. Quality Management System (QMS) Administration · Administer the QMS for the approval, issue and withdrawal of SOPs and other controlled documents. · Support internal quality control, monitoring and audit activities; coordinate visit plans, supporting paperwork, reports and follow-up actions. · Operate reminder systems for document review cycles, CAPA tracking, training records, study milestones and required reports. · Coordinate the research training and induction programme, maintaining central training and CV records, issuing approvals, reminders and warnings where appropriate, and organising sessions with attendance logs.

• Education to A-level (or equivalent).
• Evidence of training relevant to clinical research administration/GCP.
Desirable criteria
• Further/higher education in a relevant subject.
• Formal training in NHS research governance or IRAS, Proven project support experience relevant to Clinical Research
• Experience of clinical trial administration, including knowledge of GCP and NHS research governance, and use of online ethics/regulatory systems (e.g., IRAS).
Desirable criteria
• Familiarity with medical/scientific terminology
• Experience using databases to enter and report data, Strong written and verbal communication and negotiation skills
• Highly organised, methodical and able to prioritise to meet deadlines and High accuracy and attention to detail; able to work on own initiative and as part of a team.
• Advanced Office/IT skills for document management, information processing and communication
Desirable criteria
• Minute-taking and formal committee support experience.
• Experience producing management reports and dashboards.
  
  Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research.
The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence., Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence, and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel. In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism., Sexual Safety Charter: In 2023 NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles Oxford University Hospitals promotes a safe, respectful hiring environment. If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism.