CRA

Summary

Join Lindus Health as a freelance CRA to conduct risk-proportionate monitoring of global clinical trials, focusing on a major US trial involving 7,000+ patients. The role emphasizes remote monitoring, but may include onsite visits. You will prepare, conduct, and report on all monitoring visits, utilizing the Citrus platform. This position requires strong GCP/GDP knowledge, experience with DCTs, and a proactive approach. Collaboration with internal and external teams is crucial. Lindus Health offers competitive contractor rates, flexible scheduling, and the opportunity to contribute to impactful research.

Requirements

• You have 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV through close-out)
• You have developed strategies to effectively support remote monitoring
• You have experience with Decentralized Clinical Trials (DCT) and central monitoring approaches, and are familiar with reviewing and reporting data trends and anomalies
• You can review and develop monitoring plans effectively
• You understand how to take a risk-proportionate approach to monitoring and have been involved in developing monitoring plans to reflect this approach
• You have a strong working knowledge of GCP/GDP and regulatory requirements
• You have a strong awareness of clinical trial regulations and are plugged in to potential changes to the regulatory environment
• You have great attention to detail and are a confident communicator with internal and external stakeholders
• You have a bias to action - we're looking for someone who is autonomous, proactive, organised and creative who can lead their work and report back to Trial Managers

Responsibilities

• 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
• Undertake the preparation, conduct and reporting for all types of monitoring visits, from site selection through to close-out visits, as well as central monitoring through our Citrus platform
• Work closely with our Clinical Operations, Product and Commercial teams, as well as the sponsor-side teams that make up our customer base
• Act as primary contact for end-to-end site lifecycle support, particularly for our major trial across 15+ US sites, leading effective monitoring according to trial protocols, including writing Monitoring Plans, arranging and conducting site monitoring visits (primarily remote) and creating monitoring reports for all visit types from SIV to close-out
• Coordinate and lead monitoring activities and deliverables autonomously, identifying and managing issues while proactively advising Trial Managers on improvements to our processes. You may also be pulled onto other trials as business needs require
• Work closely with our tech and product teams to help design and shape our best-in-class Citrus trial monitoring platform, providing direct input that exceeds customer demands

Preferred Qualifications

• If you've already worked in a startup or early-stage environment this will be advantageous
• You're excited about helping shape clinical trial technology and don't want to work in a siloed environment

Benefits

• Work on high-impact clinical trials
• Collaborate with industry-leading teams
• Enjoy flexible scheduling and project variety
• Competitive contractor rates
• Leverage our established infrastructure and resources
• Work with a stable, well-funded organization
• Contribute your expertise to meaningful research
• Receive comprehensive support from our ClinOps team
• The flexibility of working as a contractor