Lindus Health is looking for a Freelance CRA to ensure effective, risk-proportionate monitoring across our global portfolio of clinical trials. You will have an immediate focus on a major US trial across 15+ sites and over 7,000 patients, with primary emphasis on remote monitoring using our Citrus platform. This autonomous role involves shaping monitoring strategy and collaborating with internal and external teams to fix clinical trial infrastructure.

What You'll Do

Act as primary contact for end-to-end site lifecycle support, particularly for a major trial across 15+ US sites.
Lead 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 process improvements.
Work closely with tech and product teams to help design and shape the Citrus trial monitoring platform, providing direct input that exceeds customer demands.
May be pulled onto other trials as business needs require.

What We're Looking For

3+ years of independent site monitoring experience across all types of monitoring visits from Site Selection through close-out.
Experience developing strategies to effectively support remote monitoring.
Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches.
Familiarity with reviewing and reporting data trends and anomalies.
Ability to review and develop monitoring plans effectively.
Understanding of how to take a risk-proportionate approach to monitoring and involvement in developing monitoring plans to reflect this approach.
Strong working knowledge of GCP/GDP and regulatory requirements.
Strong awareness of clinical trial regulations and potential changes to the regulatory environment.
Great attention to detail and confident communication with internal and external stakeholders.
Bias to action: autonomous, proactive, organised, creative, able to lead work and report back to Trial Managers.
Excited about helping shape clinical trial technology and don't want to work in a siloed environment.

Nice to Have

Experience already working in a startup or early-stage environment.

Team & Environment

You will work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy. You will also collaborate closely with Clinical Operations, Product, and Commercial teams, as well as sponsor-side customer teams.