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Lindus

CRA- FTC

Posted 23 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States
Mid level
Remote
Hiring Remotely in United States
Mid level
As a Clinical Research Associate, you will monitor clinical trial sites, preparing reports and managing monitoring visits while ensuring compliance with regulations.
The summary above was generated by AI

🍊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  • High-Impact, Mission-Driven Work: Lindus is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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 CRA to ensure effective, risk-proportionate monitoring of Lindus' 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 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, COV)

  • 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, organized and creative who can lead their work and report back to Trial Managers

  • You're comfortable with up to 60% travel during busy periods

  • Ideally based in the East Coast Time Zone near a major airport hub

  • Have a full US driving license

  • 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 (US)
This is a 6 months fixed term contract position

  • 20 days holiday allowance per annum (pro rataʼd to length of contract)

  • $800 monthly health insurance contribution

  • Enhanced Parental Leave - 16 weeks at full pay for primary caregivers and 4
    weeks at full pay for secondary caregivers (at 1 year of employment)

  • Please note you will not be required to join company off sites or company
    wide meetings in this role.

🍊Our hiring process 

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

  • Online Logical Reasoning and Problem Solving test (15 minutes)

  • Initial conversation with Heather, our ClinOps Talent Partner (20 minutes)

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

  • Technical/functional interview with members of our CRA team (30 minutes) 

    This will include a task you’ll need to prepare in advance of the interview and talk to

  • Values interview with a team member of leadership (15 minutes)

    A chance to get to know each other and explore how our values align

We will only contact you from lindushealth.com email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email.
We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status

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