Clinical Trial Associate
Alto Neuroscience
Summary
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.
Job description
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
Qualifications
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 is a plus
- Working with trials conducted globally is a plus
Requirements
- 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
- Risk-based monitoring (RBM) experience is a plus
- Working with trials conducted globally is a plus
Company overview
Alto Neuroscience is a clinical-stage biotechnology company pioneering precision psychiatry by developing biology-driven medicines for neuropsychiatric conditions. Founded in 2019 by Dr. Amit Etkin, a former Stanford professor, the company leverages 15 years of field-leading neuroscience research to transform the trial-and-error approach to psychiatric treatment. Alto's innovative Precision Psychiatry Platform™ utilizes AI-derived brain biomarkers, including EEG data, wearable metrics, behavioral patterns, and genetic factors, to match patients with the most effective treatments. The company's clinical-stage drug candidates target core brain processes in major depressive disorder, bipolar depression, and schizophrenia, with the goal of helping patients get better faster through personalized therapeutic solutions. Based in Mountain View, California, Alto Neuroscience represents a new paradigm in mental health treatment, combining deep neurobiological insights with advanced data analytics to deliver targeted, effective medicines for neuropsychiatric disorders.