Clinical Trials Associate

PRIMARY ROLE

The 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 studies Coordination of vendor supplies, tracking of inventory and study materials Participate in vendor User Acceptance Testing (UAT) activities Coordination of document translations, if required Assist in budget tracking and invoice review, data entry, and processing of investigator payments Liaise with the sites for specific requests (e.g., enrollment logs, missing documentation, meeting arrangements) Tracking and distribution of safety reports, as applicable Attend project meetings and generate meeting minutes Assist in the collection of ICH essential documents ensuring TMF is complete and appropriately maintained Assist in the preparation of project status reports for management review Maintain, update, and establish various databases and metrics to support Sponsor oversight responsibilities Ensure appropriate documentation of all identified site- and protocol-related issues Partner with Clinical Research Associate (CRA) to ensure completeness and accuracy of eISF and eTMF Facilitate posting and updates to Clinicaltrials.gov Other responsibilities as assigned

LOCATION

Onsite - Mountain View, CA

SALARY RANGE

$80,000- $95,000 •depending on qualifications and experience level

QUALIFCATIONS

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 Willingness to travel up to 10% overnight

Preferred Skills:

Risk-based monitoring (RBM) experience is a plus Working with trials conducted globally is a plus

WHY ALTO

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. 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. #LI - Onsite