Clinical Trial monitor – CRUK & Kings Cancer Prevention Trials Unit

Job description                   
The Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) specialises in research to advance cancer prevention, early diagnosis and screening. 
We perform research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes. 
Our portfolio of both secondary (hospital) and primary (community) care trials includes:  
Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug re-purposing 
Pragmatic trials of screening and diagnostic interventions 
Trials of behavioural interventions in cancer prevention and screening 
Trials of diagnostic/screening devices 
 
We are looking for an enthusiastic trial monitor to join the CPTU team to be responsible for the monitoring activities for an exciting new early detection study. 
You will be the trial monitor for a NHS research study of a multi-cancer early detection test with GRAIL Bio UK Ltd, NHS England and NHS Improvement.  Over 700,000 people across England will be invited to receive a novel CE-marked, blood test for the presence of over 50 cancers. As well as being responsible for project-wide monitoring, you will also lead the set-up of monitoring processes including monitoring plans and report templates and contributing to delivering site initiation/training.  This will be in close coordination with GRAIL Bio UK, CPTU Project and Trial Managers, and other key stakeholders. 
You will have a strong interest in, and knowledge of clinical trials research, and prior monitoring experience, including on-site, remote and central monitoring within academia, the NHS or commercial health research sector. You will have excellent attention to detail and planning skills with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation.  The ability to communicate clearly, concisely, and professionally is essential. 
 
Coordinate and deliver monitoring activities across multiple regions in England, related to protocol and GCP compliance, human tissue and data collection and processing  
Ensure all necessary approvals are in place, recruiting sites are initiated and closed following agreed procedures, and staff are appropriately trained  
Oversee compliance to research and other applicable regulations and good practices, and manage deviations where required 
Monitor vendors providing services for the research project  
You will report to the CPTU QA Manager and work closely with the wider NHS-Galleri project team including the Clinical Project Manager, Trial Manager and Research Nurses. Travel to different sites in England will be expected on a regular basis.  
 
This post is a Full-time 35 hours per week
This is a Fixed-term until 31 July 2024
 

Key responsibilities

• Develop and implement the monitoring plan
• Coordinate and deliver the central, remote and on-site monitoring activities for investigator sites and vendors e.g. review of consent, blood collections and processing, participant follow up pathways, investigator site files, staff training etc., ensuring that the trial is conducted in accordance with the protocol, and applicable ethical, regulatory and quality standards, and that appropriate records and audit trails are maintained
• Ensure trial sites have the required documentation, appropriate approvals and have been adequately trained
• In conjunction with the trial statistician and data manager, monitor data quality and assist with data cleaning and queries, and communication to sites, to achieve an accurate and complete dataset
• Ensure compliance to the Sponsor’s chosen SOPs and that appropriate contractual arrangements are in place and documents held on file
• Work, where applicable, with the Sponsor, Chief Investigator(s), grant co-applicants, data managers, research nurses & practitioners, clinicians, statisticians and external parties/vendors on a daily basis to ensure compliance with the monitoring plan and protocol
• Train other staff (internal and external) involved in consent, data collection and data entry in the rules and procedures to be used, explaining the reasons/ principles behind them
• Communicate the underlying medical and scientific rationale of the trial, and regulatory requirements to a wide professional audience, to ensure protocol compliance
• Plan and organise the logistical aspects of monitoring visits
• Clearly and concisely record monitoring findings in monitoring reports and discuss with / escalate to line manager, clinical project manager, Chief Investigator and Sponsor where required, and ensure timely resolution of findings by study staff
• Proactively work to prevent issues arising where possible, and use initiative and creativity to resolve issues that might arise, identifying those that require onward reporting to the Chief Investigator and Sponsor
• Produce monthly monitoring reports
• Where necessary, manage reported SAEs, checking for missing or inconsistent data and querying sites.  Ensure reports are reviewed appropriately and sent to any key parties (i.e. CI), and ensure all events are followed up to resolution
• Ensure strict confidentiality on all matters and information obtained during the course of employment

 
 
Skills, knowledge, and experience 
 
Essential criteria

1. Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse) or equivalent experience
2. Previous monitoring experience including on-site, remote and central monitoring within academia, the NHS or commercial health research sector
3. Excellent understanding of ICH-GCP guidelines and other applicable regulations, including the regulations governing the research use of in vitro diagnostics, and how they are applied in a trial setting
4. Excellent IT skills including working with complex databases and information management systems
5. Understanding of medical terminology, either through study or working in a medical environment
6. Understanding of NHS research structure and organisation
7. The ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
8. Ability to work on own initiative and prioritise own schedule without supervision as well as with multiple stakeholders
9. Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner. Ability to persuade and deliver information effectively through presentations or training materials
10. Willing to travel within England flexibly to accommodate the needs of the project
11. Ability to show attention to detail and high standards of accuracy in all aspects of work

 
Desirable criteria

1. Formal qualification in clinical trials (or working towards one) and/or post graduate qualification with a research methodology element
2. Proven experience of all stages of a clinical trial from start up to close-out
3. Experience of monitoring/audits of clinical trial vendors

Further information
This post is based at Guy’s Hospital, London Bridge and GRAIL’s office in central London but will be remote working until further notice.