CRA- FTC

Lindus

13d • Hybrid

About The Position

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.

Requirements

• 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV, COV)
• Developed strategies to effectively support remote monitoring
• Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches, and are familiar with reviewing and reporting data trends and anomalies.
• Can review and develop monitoring plans effectively
• Understand how to take a risk-proportionate approach to monitoring and have been involved in developing monitoring plans to reflect this approach
• Strong working knowledge of GCP/GDP and regulatory requirements.
• Strong awareness of clinical trial regulations and are plugged in to potential changes to the regulatory environment
• Great attention to detail and are a confident communicator with internal and external stakeholders
• Bias to action - autonomous, proactive, organized and creative who can lead their work and report back to Trial Managers
• Comfortable with up to 60% travel during busy periods
• Full US driving license

Nice To Haves

• Ideally based in the East Coast Time Zone near a major airport hub
• Already worked in a startup or early-stage environment
• Excited about helping shape clinical trial technology and don't want to work in a siloed environment

Responsibilities

• 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. 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.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed