Clinical Trial Associate

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $60.8k - $91.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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Karius

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Karius is a biotechnology company specializing in infectious disease diagnostics. The company uses genomics and artificial intelligence to detect microbial cell-free DNA from pathogens in the bloodstream, enabling the identification of over 1000 pathogens causing infections. Karius aims to transform infectious disease diagnosis with the help of clinical metagenomics, providing clear and timely diagnostic results. Their innovative Karius Test is a novel liquid biopsy designed to provide clinicians with comprehensive diagnostic insights into infections, even in immunocompromised patients.

📋 Description

• Support CRAs and study teams across Karius clinical studies • Collect, quality-control, and quality-assure study and trial-related regulatory documents • Set up and maintain Trial Master Files (TMFs) according to sponsor SOPs, the TMF Reference Model, ICH-GCP, and applicable regulatory requirements • Review, file, and maintain regulatory documents accurately and promptly within the TMF • Identify TMF gaps and track missing or outstanding documents through resolution • Communicate with clinical sites and study teams to request and follow up on outstanding documents • Maintain Investigator Site Files (ISFs) • Develop and maintain study templates, trackers, forms, and other study tools • Maintain study materials using Google Sheets, Docs, and Drive • Prepare TMF and ISF documentation for audits and inspections • Support investigator meeting planning, coordination, logistics, and follow-up • Maintain study communication and distribution lists • Support study start-up documentation collection and tracking • Track study milestones, deliverables, and action items • Coordinate study meetings, including scheduling, agendas, materials, meeting notes, and action items • Support document archiving and study closeout activities • Provide administrative and operational support to clinical study teams

🎯 Requirements

• Bachelor's degree in life sciences, health sciences, clinical research, or a related field, or an equivalent combination of education and experience • 1-3 years of experience in clinical research, clinical operations, regulatory documentation, or a related environment • Basic understanding of clinical research processes and compliant clinical trial execution • Familiarity with Trial Master Files (TMFs), Investigator Site Files (ISFs), or other clinical study documentation systems, or ability to quickly learn applicable processes and standards • Basic knowledge of, or willingness to learn, ICH-GCP, FDA regulations, and other applicable clinical research requirements • Familiarity with medical and clinical research terminology, or ability to learn technical terminology quickly • Strong attention to detail and ability to review documentation for completeness, accuracy, consistency, and appropriate filing • Strong organizational and time management skills; ability to manage multiple tasks, maintain trackers, follow up on outstanding items, and meet timelines • Strong written and verbal communication skills • Ability to follow established procedures, incorporate feedback, and work effectively under guidance • Demonstrated accountability, reliability, and follow-through • Proficiency with Microsoft Office Suite and Google Workspace • Ability to learn clinical research systems and document management platforms • Ability to work effectively in a collaborative, fast-paced environment while maintaining accuracy, confidentiality, and attention to detail

🏖️ Benefits

• Travel required up to 10-20% • Equal employment opportunities and commitment to workplace diversity and inclusion • Accommodation for qualified individuals with disabilities