Role Description
We're looking for a freelance CRA to ensure effective, risk-proportionate monitoring of Lindus Health's global portfolio of clinical trials, with immediate focus on supporting a major trial across 15+ US sites involving over 7,000 patients. Primary emphasis on remote monitoring, though some onsite visits may be required.
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Undertake the preparation, conduct and reporting for all types of monitoring visits, from site selection through to close-out visits.
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Conduct central monitoring through our Citrus platform.
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Maintain high monitoring standards as our customer base grows significantly.
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Work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy.
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Collaborate closely with Clinical Operations, Product and Commercial teams, as well as sponsor-side teams.
Qualifications
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3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV through close-out).
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Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches.
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Strong working knowledge of GCP/GDP and regulatory requirements.
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Great attention to detail and confident communication with internal and external stakeholders.
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Experience in a startup or early-stage environment is advantageous.
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Excitement about shaping clinical trial technology and working in a collaborative environment.
Requirements
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Develop strategies to effectively support remote monitoring.
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Review and develop monitoring plans effectively.
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Understand how to take a risk-proportionate approach to monitoring.
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Strong awareness of clinical trial regulations and potential changes to the regulatory environment.
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Autonomous, proactive, organized, and creative with a bias to action.
Benefits
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Work on high-impact clinical trials.
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Collaborate with industry-leading teams.
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Enjoy flexible scheduling and project variety.
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Competitive contractor rates.
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Leverage established infrastructure and resources.
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Work with a stable, well-funded organization.
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Contribute expertise to meaningful research.
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Receive comprehensive support from our ClinOps team.
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Flexibility of working as a contractor.
Company Description
We're powering biology's century with radically faster, more reliable clinical trials. Our mission is to fundamentally change the clinical trial infrastructure, ensuring new treatments reach patients faster.
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Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients.
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Recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.