Clinical Trial Associate

Alto Neuroscience; Mountain View (CA); On-site; USD 80,000 - 95,000; Full time

Job summary

Alto Neuroscience, Mountain View, CA, is seeking a Clinical Trial Associate to support 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. In-office role with up to 10% travel.

Salary range $80,000 to $95,000 depending on qualifications and experience.

Qualifications

• Bachelor's degree in science, nursing, or equivalent.
• Familiarity with FDA/EMA regulations, ICH guidelines, and GCPs governing clinical trials.
• Experience with eTMF management and TMF platforms.
• Strong communication and organizational skills.

Responsibilities

• Set up, organize, and maintain study documentation and study-level files.
• Assist in start-up, management, close-out, and reporting of clinical studies.
• Coordinate vendor supplies and study materials; track inventory.
• Participate in vendor UAT activities and translations if required.
• Assist in budget tracking, data entry, and investigator payments; liaise with sites for requests.

Skills

Interpersonal communication

Attention to detail

Organizational skills

Verbal and written communication

Education

Bachelor's degree in science, nursing, or equivalent

Tools

MS Office Suite

Outlook

Gmail

EDC platforms

TMF platforms

Job description

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 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

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

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

Physical Demands & Work Environment

Required to sit for prolonged periods of time. While performing the duties of this job, the noise level in the work environment is usually quiet.

Equal Opportunity Statement

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.