CRA

Job description

🍊Our mission

All new medicines need to undergo clinical trials to show they’re safe and effective. But today’s clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait longer and pay more for new treatments.

Our mission is to fix this; we use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. We’re still a young company, but we’ve already had a big impact. 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, 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.

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 and 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.

🍊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)

• 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

• 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

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

🍊What you’ll focus on

• Focus area 1: You’ll 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.

• Focus area 2: You’ll 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.

• Focus area 3: You’ll 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.

🍊What we offer

• 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

🍊Our hiring process

• Online Logical Reasoning and Problem Solving test (20 minutes)

• Initial conversation with Cam, our ClinOps Talent Partner (15 minutes)

• Second conversation with one of our AD of ClinOps (30 minutes)

• Technical/functional interview with an AD of ClinOps and a member of our CRA team(45 minutes)