CRA

Summary

Join Lindus Health as a Clinical Research Associate (CRA) to play a pivotal role in monitoring clinical trials globally, focusing on a major trial across 15+ US sites. You will be responsible for remote monitoring, with potential for onsite visits, conducting all monitoring visit types, and utilizing the Citrus platform for central monitoring. This role requires strong collaboration with internal teams and sponsors, contributing to high monitoring standards. The ideal candidate possesses 3+ years of independent site monitoring experience, expertise in remote monitoring and DCTs, and a strong understanding of GCP/GDP and regulations. The position offers a competitive salary, stock options, unlimited holidays, and various benefits including health insurance contributions, wellness allowance, parental leave, and professional development opportunities.

Requirements

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

Responsibilities

• 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
• 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
• Maintain 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
• Work closely with our Clinical Operations, Product and Commercial teams, as well as the sponsor-side teams that make up our customer base
• 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
• 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
• 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

Preferred Qualifications

• Ideally based in the Central Time Zone near a major airport hub
• Have a full US driving licence
• 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

Benefits

• Competitive salary, plus meaningful stock options
• Unlimited holidays; everyone is encouraged to take off at least 28 days each year
• $800 monthly employer contribution towards insurance coverage through our PEO Trinet
• $40 monthly wellness allowance with complete flexibility on how to spend this including opting in to wellhub membership, expensing wellness items and more!
• Access to gym and retail discounts through our benefits platform Happl
• Enhanced Parental Leave - 16 weeks full pay for primary care giver, followed by 23 weeks at the UK statutory rate & 6 weeks full pay for secondary care giver
• Monthly lunch voucher for our remote teams
• Regular whole company and team events, both in person and virtually!
• $2,000 Learning and Development allowance each year to put towards courses, certifications and development