CRA- FTC at Lindus Health

You are an experienced Clinical Research Associate with at least three years of independent site monitoring experience across all visit types. You possess deep

Work type: remote

Location: US

Type: Contract

Summary

You are an experienced Clinical Research Associate with at least three years of independent site monitoring experience across all visit types. You possess deep knowledge of GCP and GDP standards and are comfortable navigating the complexities of decentralized clinical trials. **What makes it worth a look...** Lindus Health offers a six-month contract as a fully remote role in the US, providing an $800 monthly health insurance contribution. You will support a major trial across 15 sites while influencing the development of their proprietary Citrus monitoring platform. **You might be a good fit if you...** * Have 3+ years of independent site monitoring experience covering SIV, IMV, and COV. * Possess hands-on experience with decentralized clinical trials and central monitoring strategies. * Maintain a valid US driving license and can manage up to 60% travel during peak periods. * Are based in the East Coast time zone near a major airport hub.

Job Description

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• High-Impact, Mission-Driven Work:Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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

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 youWe’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

🍊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.

• 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

• Please note you will not be required to join company off sites or companywide meetings in this role.🍊Our hiring process 

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

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

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

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

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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