Clinical Trial Monitor

Job Description

About Us:

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

About The Role

We are looking for an enthusiastic trial monitor to join the CPTU team to be responsible for the monitoring activities for an exciting cancer early detection study. You will be the trial monitor for a NHS research study of a multi-cancer early detection test working closely with project partners GRAIL Bio UK Ltd, NHS England and NHS Improvement. Over 1,000,000 people across England will be invited to receive a novel blood test for the presence of over 50 cancers. As well as being responsible for leading project-wide monitoring, you will also lead the ongoing maintenance and implementation of monitoring processes including monitoring plans and report templates and contributing to delivering site training. This will be in close coordination with GRAIL Bio UK, CPTU Project and Trial Managers, and other key stakeholders.

This post will be hybrid working including a combination of office working, home working and travel around England to conduct on-site monitoring visits.

You Will
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 Operations Manager and work closely with the wider NHS-Galleri project team including the Clinical Project Manager, Trial Manager and Research Nurses.

This post will be offered on an a fixed-term contract for 12 months (please note this is a maternity cover post)

This is a full-time post – 100% full time equivalent

Key responsibilities
Maintain, implement and suggest ongoing improvements to the trial 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
Work with research site staff to understand the root cause of monitoring findings, support their resolution and proactively help to overcome issues/barriers
Ensure trial sites have the required documentation, appropriate approvals and have been adequately trained
In conjunction with the trial statistician and data manager, oversee the central monitoring of 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
Communicate the underlying medical and scientific rationale of the trial, and regulatory requirements to a wide professional audience, to ensure protocol compliance
Clearly and concisely communicate to a range of project stakeholders and deliver presentations to varied audiences e.g. training, Sponsor updates etc.
Plan and organise the logistical aspects of monitoring visits
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
Clearly and concisely record monitoring findings, autonomously producing high-quality monitoring reports and tracking tools 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
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
Work with others supporting monitoring activities in the trial to provide comprehensive monitoring coverage according to the agreed schedule
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
Ensure strict confidentiality on all matters and information obtained during the course of employment.

Skills, Knowledge, And Experience

Essential criteria:
Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse) or equivalent experience
Previous monitoring experience including on-site, remote and central monitoring within academia, the NHS or commercial health research sector
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
Excellent IT skills including working with complex databases and information management systems
Understanding of medical terminology, either through study or working in a medical environment
The ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
Ability to work on own initiative and prioritise own schedule without supervision
Excellent verbal and written communication skills, particularly in the context of concise scientific writing, reports and good telephone manner. Ability to persuade and deliver information effectively through presentations or training materials.
Willing to travel within England flexibly to accommodate the needs of the project
Ability to show attention to detail and high standards of accuracy in all aspects of work

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

Further information

Please contact [email protected]