Clinical Trial Associate
Posted 1hrs ago
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Job Description
Clinical Trial Associate supporting Karius’s genomic infectious-disease diagnostics through TMF and ISF documentation. Coordinating regulatory records, study meetings, milestones, audits, and clinical-site follow-up.
Responsibilities:
- 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
