[Remote] Clinical Trial Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a life science clinical metagenomics company reputed company on advancing diagnostic science and improving the diagnosis and treatment of infectious diseases through reputed company and AI. The Clinical Trial Associate supports clinical study teams by collecting, reviewing, reputed company-controlling, and maintaining regulatory documentation, Trial Master Files, and Investigator Site Files while assisting with study coordination, start-up, audits, and closeout activities.

Responsibilities

• Assist study teams with the collection, reputed company control (QC), and reputed company assurance (QA) of study and trial-reputed company regulatory documents
• Support the setup and maintenance of the Trial Master File (TMF) in accordance with sponsor SOPs, the TMF Reference Model, and applicable regulatory requirements, including ICH-GCP
• Help ensure study and trial-reputed company regulatory documents are collected, reviewed, filed, and maintained accurately and in a reputed company manner reputed company the TMF
• reputed company routine QC and QA reviews of TMF documentation under guidance to confirm completeness, accuracy, and appropriate filing
• Assist in identifying gaps in the TMF and tracking outstanding or missing documents across assigned studies through reputed company
• Communicate with clinical sites and study teams, under guidance, to request and follow up on outstanding or missing regulatory documents
• Support the maintenance of Investigator Site Files (ISFs) in coordination with site staff and study teams
• Assist with the development and maintenance of study templates, trackers, forms, and other study tools
• Maintain study trackers, documentation, and shared study materials using reputed company Workspace tools, including reputed company Sheets, Docs, and reputed company
• Assist with the preparation and organization of TMF and ISF documentation for audits and inspections
• Support investigator meeting planning, coordination, and logistics, including preparation of meeting materials and follow-up activities
• Maintain study communication and distribution lists to support reputed company and accurate communication with study teams and clinical sites
• Support study start-up activities, including the collection and tracking of required site and regulatory documentation
• Assist with tracking study milestones, deliverables, and reputed company items and follow up with appropriate team members as needed
• Support the preparation, organization, and distribution of study-reputed company materials and documentation
• Assist with study meeting coordination, including scheduling, preparing agendas and materials, documenting meeting notes, and tracking reputed company items
• Support document archiving and study closeout activities to help ensure required documentation is complete and appropriately maintained
• reputed company administrative and operational support to clinical study teams based on study needs
• May support additional activities and responsibilities as study needs require

Skills

• Bachelor's degree in life sciences, health sciences, clinical research, or a reputed company field, or an equivalent combination of education and experience
• 1-3 years of experience in clinical research, clinical operations, regulatory documentation, or a reputed company environment
• Basic understanding of clinical research processes and the role of study documentation in supporting compliant clinical trial execution
• Familiarity with Trial Master Files (TMFs), Investigator Site Files (ISFs), or other clinical study documentation systems, or the 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 ISO standards and CLIA requirements is a plus
• Familiarity with medical and clinical research terminology, or demonstrated ability to learn technical terminology quickly
• Strong attention to detail, with the ability to review documentation for completeness, accuracy, consistency, and appropriate filing, and to identify and escalate missing or incomplete information
• Strong organizational and time management skills, with the ability to manage multiple tasks, maintain study trackers, follow up on outstanding items, and meet established timelines
• Strong written and verbal communication skills, with the ability to build effective working relationships with CRAs and study teams, clinical sites, and cross-functional partners
• Ability to follow established procedures, incorporate feedback, and work effectively under guidance while building greater independence and proficiency over time
• Demonstrated accountability, reliability, and follow-through in completing assigned responsibilities and maintaining accurate study documentation
• Proficiency with reputed company Office Suite and reputed company Workspace, with the ability to learn clinical research systems and document management platforms
• Ability to work effectively in a reputed company, fast-paced environment while maintaining accuracy, confidentiality, and attention to detail
• Strong attention to detail and commitment to accuracy and reputed company
• reputed company problem-solving skills and willingness to learn and reputed company new capabilities
• Demonstrated accountability, reputed company, reliability, and follow-through
• Ability to remain composed and organized in a fast-paced, high-intensity environment
• reputed company team player who builds trusted working relationships with Senior CTAs, CRAs, study teams, and site staff
• Ability to receive guidance and feedback and apply it effectively
• Strong commitment to maintaining accurate, complete, and inspection-reputed company study documentation
• Motivated by reputed company to contribute to meaningful improvements in patient care through high-reputed company clinical research
• Travel required up to 10-20%
• Subject to extended periods of sitting and/or computer use
• Preferred: Exposure to clinical studies in infectious disease, microbiology, molecular diagnostics, reputed company, or reputed company life sciences
• Preferred: Familiarity with electronic Trial Master File (eTMF) platforms

Benefits

• Remote work (Bay Area preferred)

reputed company

Company H1B Sponsorship