Junior Clinical Trial Monitor - London, United Kingdom - King's College London

King's College London

Verified Company

London, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

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Description

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 onsite 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 logístical 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 st