Junior Clinical Trial Monitor
This vacancy is published by an accredited employer with authorized corporate payroll and standard compliance adherence.
Transatlantic Cost of Living & Purchasing Power Benchmark
Position Overview & Specifications
- 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.
- 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
- 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.
Candidate Selection & Onboarding Process
Application & Resume Screening
Submit your tailored CV/Resume directly to the talent acquisition portal.
Technical & Competency Interviews
Virtual interviews with the hiring manager and multidisciplinary team.
Formal Offer & Benefits Negotiation
Written agreement outlining compensation, equity, retirement vesting, and relocation allowances.
Onboarding & Corporate Integration
Equipment provisioning, team orientation, and commencement of duties.
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Junior Clinical Trial Monitor • King's College London
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