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Salary: USD 80,000 - 95,000 / annual
Alto Neuroscience is seeking a Clinical Trial Associate to support the clinical operations team in advancing precision psychiatry and personalized neuroscience-based therapeutics. This role is responsible for creating, distributing, maintaining, and organizing study materials, tools, and documents to ensure clinical trials are conducted in compliance with protocol requirements, SOPs, and ICH GCP Guidelines.
Key responsibilities include:
- Set up, organize, and maintain clinical study documentation, study-level files, and overall filing of study-specific documentation
- Assist in the start-up, management, close-out, and reporting of assigned clinical studies
- Coordinate vendor supplies, track inventory, and manage study materials
- Participate in vendor User Acceptance Testing (UAT) activities
- Coordinate document translations as required
- Assist in budget tracking, invoice review, data entry, and processing of investigator payments
- Liaise with clinical sites for specific requests (enrollment logs, missing documentation, meeting arrangements)
- Track and distribute safety reports as applicable
- Attend project meetings and generate meeting minutes
- Assist in collection of ICH essential documents, ensuring Trial Master File (TMF) is complete and appropriately maintained
- Prepare project status reports for management review
- Maintain, update, and establish databases and metrics to support sponsor oversight
- Document all identified site- and protocol-related issues
- Partner with Clinical Research Associates (CRAs) to ensure completeness and accuracy of electronic ISF and eTMF
- Facilitate posting and updates to ClinicalTrials.gov
- Perform additional responsibilities as assigned
The position is based in Mountain View, CA, in-office. Travel up to 10% overnight is required.
REQUIREMENTS:
Required Skills:
- Bachelor's degree in science, nursing, or equivalent
- Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Familiarity with pharmaceutical and medical terminology
- Experience with management and oversight of eTMF
- Experience with EDC and TMF platforms
- Excellent interpersonal, verbal, and written communication skills
- Strong attention to detail and organizational skills
- Strong knowledge of MS Office Suite, Outlook, and Gmail
Preferred Skills:
- Risk-based monitoring (RBM) experience
- Experience working with trials conducted globally
