CRA (Freelance)

About Us

Our mission is to fix the outdated clinical trial infrastructure that has caused the cost of developing new medicines to skyrocket. We use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. Since founding the company in March 2021, we’ve helped run over 100 clinical trials involving tens of thousands of patients, with a customer NPS of 100. We recently raised a $55m Series B round from Balderton Capital, with support from Creandum, Firstminute, Seedcamp, and Visionaries.

About the Role

We're looking for a freelance CRA to ensure effective, risk-proportionate monitoring of Lindus Health's global portfolio of clinical trials. The primary focus will be on supporting a major trial across 15+ US sites involving over 7,000 patients, with an emphasis on remote monitoring, though some onsite visits may be required.

You will 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. This freelance role is integral to maintaining high monitoring standards as our customer base grows significantly. It requires someone who can work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy. You'll work closely with our Clinical Operations, Product, and Commercial teams, as well as the sponsor-side teams that make up our customer base.

Location Type: Remote Employment Type: Contract

About You

We’d like to hear from you if you have:

• 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV through close-out).
• Developed strategies to effectively support remote monitoring.
• Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches, and are familiar with reviewing and reporting data trends and anomalies.
• The ability to review and develop monitoring plans effectively.
• An understanding of how to take a risk-proportionate approach to monitoring and have been involved in developing monitoring plans to reflect this approach.
• Strong working knowledge of GCP/GDP and regulatory requirements.
• Strong awareness of clinical trial regulations and are plugged into potential changes to the regulatory environment.
• Great attention to detail and are a confident communicator with internal and external stakeholders.
• 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.
• Experience working in a startup or early-stage environment will be advantageous.
• Excitement about helping shape clinical trial technology and a desire not to work in a siloed environment.

If your experience and interests match with some of the above, we want you to apply.

What You'll Focus On

Focus Area 1: Site Lifecycle Support

• Act as the primary contact for end-to-end site lifecycle support, particularly for our 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.

Focus Area 2: Monitoring Coordination and Issue Management

• Coordinate and lead monitoring activities and deliverables autonomously.
• Identify and manage issues while proactively advising Trial Managers on improvements to our processes.
• May be pulled onto other trials as business needs require.

Focus Area 3: Platform Development Collaboration

• Work closely with our tech and product teams to help design and shape our best-in-class Citrus trial monitoring platform.