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Job Type
Full-time, Contract
Description
The Clinical Trial Assistant (CTA) provides operational and administrative support to the Clinical Operations team in the execution of Sagimet's clinical trials. This role requires a highly organized, detail-oriented individual who can manage multiple priorities and contribute across a broad range of clinical and regulatory activities. The CTA will play a hands-on role in trial start-up, maintenance, and close-out activities, partnering closely with Clinical Trial Managers (CTMs),, vendors, and cross-functional internal stakeholders. The CTA will report to the Senior Vice President, Clinical Operations.
Essential Responsibilities:
- Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times
- Assist with study start-up activities, including collection and tracking of regulatory documents (e.g., 1572s, CVs, licenses, IRB/EC approvals)
- Support site activation, maintenance, and close-out processes
- Track and manage clinical trial documentation, ensuring accuracy, completeness, and timeliness
- Assist with creation, review, and formatting of study-related documents (protocols, manuals, study plans, etc.)
- Prepare or oversee CRO with clinical trial materials including investigator site binders, study tools, and training materials
- Assist CRO and internal team with oversight of sample tracking vendor and dashboard.
- Track operational deliverables, timelines, and key milestones
- Assist in organizing investigator meetings, vendor meetings, and internal study team meetings
- Draft meeting agendas, capture meeting minutes, and follow up on action items
- Maintain study tracking tools and spreadsheets (e.g., site lists, enrollment trackers, document trackers)
- Support review of data entry and reconciliation activities across systems (e.g., CTMS, eTMF, EDC where applicable)
- Assist in the preparation of status reports and dashboards for internal stakeholders
- Ensure compliance with GCP, SOPs, and applicable regulatory requirements
- Support audit and inspection readiness activities, including documentation preparation and QC
- Assist in tracking and filing safety reports and regulatory submissions
- Provide administrative support to the Clinical Operations team as needed
- Manage document version control and filing systems
- Support cross-functional collaboration with Regulatory, Quality, and Clinical Development
- Other duties as assigned
Requirements
Education and Experience Requirements:
- Bachelor's degree in life sciences, healthcare, or related field preferred
- 2-4 years of experience in clinical research, clinical operations, or a related field
- Experience in a biotech, pharma, or CRO environment preferred; startup experience a plus
- Strong organizational skills with exceptional attention to detail
- Ability to manage multiple tasks and prioritize effectively in a fast-paced environment
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); familiarity with CTMS/eTMF systems preferred
- Understanding of ICH-GCP guidelines and clinical trial processes