Junior 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 repurposing

• 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 individual with experience in clinical trials administration/data management or coordination to join the CPTU as a Junior Clinical Trials Monitor to assist with central source data review and other monitoring activities for an exciting early detection trial. You will be one of two Junior Clinical Trial Monitors working with the main Clinical Trial Monitor for the NHS-Galleri trial, which is a clinical trial of a new multi-cancer early detection blood test. The CPTU is working with GRAIL Bio UK Ltd, NHS England and NHS Improvement to carry out this trial. Over 700,000 people across England have been invited to receive a novel CE-marked, blood test for the presence of over 50 cancers. This post will be based at the CPTU offices in KCL’s Guy’s Campus at London Bridge, and remotely in a hybrid working model (40-60%), but the post holder will also be required to travel to other national sites regularly. You will:

• Be primarily responsible for delivering centrally reviewed source data verification and quality checks of informed consent forms and sample accountability logs

• Ensure full tracking and reporting of central data review progress

• Assist with some on site monitoring activities (on average one visit per month) across multiple regions in England, related to protocol and ICH-GCP compliance, human tissue and data collection and processing

• Ensure compliance to research and other applicable regulations and good practices, and assist in deviations management where required

You will report to the CPTU Operations Manager (Compliance) and the NHS Galleri Clinical Trial Monitor, and work closely with the wider NHS-Galleri project team including the Clinical Project Manager, Trial Manager and Research Nurses. You will also work in close coordination with GRAIL Bio UK and other key stakeholders. Travel to different sites in England will be expected on a monthly basis. This post will be offered on an a fixed term contract for 12 months This is a full-time post

Key responsibilities

• Perform central review and verification of source data, specifically informed consent forms, and sample accountability in accordance with the monitoring plan

• Perform overall quality checking of completed informed consent forms

• Ensure full tracking of data review progress, including percentage of checks completed and outstanding

• Assist with delivery of other remote and on-site monitoring activities for investigator sites and vendors e.g., SDV, 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

• Assist in ensuring trial sites have the required documentation, appropriate approvals and have been adequately trained

• Assist in ensuring compliance to the Sponsor's chosen SOPs

• Ensure immediate and appropriate escalation and communication of issues and deviations found during data review and monitoring visits where required

• Assist in communicating the underlying medical and scientific rationale of the trial, and regulatory requirements to a wide professional audience, to ensure protocol compliance

• Plan, organise and execute the completion of central data review, SDV, and quality checks

• 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 wider NHS Galleri Team

• Clearly and concisely record data review and monitoring findings in reports and discuss with / escalate to Clinical Trial Monitor, line manager, Clinical Project Manager, Chief Investigator and Sponsor where required, and ensure timely resolution of findings by study site staff

• Produce regular and timely monitoring reports, and data review progress 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.

• Assist in the training of other staff (internal and external) involved in informed consent, data collection and data entry in the rules and procedures to be used, explaining the reasons / principles behind them.

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. 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 experience of clinical research within an academic institution, NHS Trust, or Clinical Research Organisation 3. Understanding of ICH-GCP guidelines and other applicable regulations 4. Ability to show attention to detail and high standards of accuracy in all aspects of work 5. Excellent IT skills including working with complex databases and information management systems 6. Basic data management skills, including the ability to extract, manipulate and collate large sets of data 7. Understanding of medical terminology, either through study or working in a medical environment 8. Ability to work on own initiative and prioritise own schedule without supervision 9. Excellent verbal and written communication skills, particularly in the context of concise scientific writing, reports, and good telephone manner 10. Willing to travel within England flexibly to accommodate the needs of the project Desirable criteria 1. Previous monitoring experience including on-site, remote and central monitoring within academia, the NHS or commercial health research sector 2. Understanding of the regulations governing the research use of in vitro diagnostics, and how they are applied in a trial setting 3. Experience of multiple stages of a clinical trial (start up to close-out) 4. Able to identify and resolve problems that are critical to the running of the trial and plan to avoid them 5. Experience of working with clinical trial vendors Further information Informal enquiries are welcomed to discuss this role, and can be directed to Harriet Gilbert-Jones, Operations Manager (Compliance) : harriet.j.gilbert-jones@kcl.ac.uk