CRA (Freelance)

Reposted 21 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
Mid level
Healthtech
The Role
The freelance CRA will monitor and support clinical trials, managing site monitoring visits, developing monitoring strategies, and interfacing with various teams to ensure compliance and effective operations.
Summary Generated by Built In

🍊Our mission 

We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don’t get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster.

Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

🍊What's it like to work here?

When you join us, you’ll experience:

  • High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.

  • Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You’ll take on real responsibility, work across different areas, and actively shape the company’s success.

  • Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged.

Ready to power biology's century? We'd love to hear from you.

🍊About the role
We're looking for a West coast-based 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 are based in the MST or PST timezones

  • 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

We believe in rewarding the people who are building the future of clinical research.

  • 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

We believe hiring should be transparent, respectful of your time, and give you a real feel for what Lindus Health is like. Here's what to expect:

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

  • Initial conversation with Cam, our ClinOps Talent Partner (30 minutes)

    Get to know each other, discuss the role, and answer any questions about Lindus

  • Technical interview with our Lead CRA or an AD of Clin Ops (30 minutes)

    Deep dive into your experience and how you'd approach key challenges

Top Skills

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The Company
HQ: London
109 Employees

What We Do

Lindus Health is an anti-CRO running radically faster, more reliable clinical trials for life science pioneers.

We do this thanks to a commercial model that aligns incentives (fixed-price quotes per study, with milestone-based payments), marrying a world-class clinical operations team with our unique software platform, and access to 30 million Electronic Health Records. We handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

We have helped over 100 sponsors run entire clinical studies across the US, UK, and Europe up to 2x faster than traditional CROs

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