Clinical Trial Associate

About Alto Neuroscience, Inc. At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics. Primary Role The Clinical Trial Associate (CTA) position is responsible for the support of the study team by creating, distributing, maintaining, and organizing study materials, tools and documents to ensure conduct of clinical trials is in compliance with protocol requirements, SOPs and ICH GCP Guidelines. Additional responsibilities include general administrative support to the Clinical Operations Department. What You'll Do 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 studiesCoordination of vendor supplies, tracking of inventory and study materialsParticipate in vendor User Acceptance Testing (UAT) activitiesCoordination of document translations, if requiredAssist in budget tracking and invoice review, data entry, and processing of investigator paymentsLiaise with the sites for specific requests (e.g., enrollment logs, missing documentation, meeting arrangements)Tracking and distribution of safety reports, as applicableAttend project meetings and generate meeting minutesAssist in the collection of ICH essential documents ensuring TMF is complete and appropriately maintainedAssist in the preparation of project status reports for management reviewMaintain, update, and establish various databases and metrics to support Sponsor oversight responsibilitiesEnsure appropriate documentation of all identified site- and protocol-related issuesPartner with Clinical Research Associate (CRA) to ensure completeness and accuracy of eISF and eTMF Facilitate posting and updates to Clinicaltrials.govOther responsibilities as assigned Location In office, Mountain View, CA Salary Range $80,000 to $95,000 depending on qualifications and experience level Travel Required Willingness to travel up to 10% overnight Qualifications Required Skills: Bachelor’s degree in science, nursing, or equivalentWorking knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trialsFamiliarity with pharmaceutical and medical terminologyExperience with management and oversight of eTMFExperience with EDC and TMF platformsExcellent interpersonal, verbal, and written communication skillsStrong attention to detail and organizational skillsStrong knowledge of MS Office Suite, Outlook and Gmail Preferred Skills Risk-based monitoring (RBM) experience is a plusWorking with trials conducted globally is a plus Physical Demands & Work Environment Required to sit for prolonged periods of timeWhile performing the duties of this job, the noise level in the work environment is usually quiet Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.