Clinical Trial Associate

Alto Neuroscience•Mountain View, CA

41d•$80,000 - $95,000•Onsite

About The Position

The Clinical Trial Associate (CTA) supports the study team by creating, distributing, maintaining, and organizing study materials, tools, and documents to help ensure clinical trials are conducted in compliance with protocol requirements, SOPs, and ICH GCP Guidelines. The position also provides general administrative support to the Clinical Operations Department. This role is based in the office in Mountain View, California, and may require up to 10% overnight travel.

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.
Willingness to travel up to 10% overnight.

Nice To Haves

Risk-based monitoring (RBM) experience.
Experience working with trials conducted globally.

Responsibilities

Set up, organize, and maintain clinical study documentation, study-level files, and study-specific filing.
Assist with the start-up, management, close-out, and reporting of assigned clinical studies.
Coordinate vendor supplies and track inventory and study materials.
Participate in vendor User Acceptance Testing (UAT) activities.
Coordinate document translations, if required.
Assist with budget tracking, invoice review, data entry, and processing investigator payments.
Liaise with sites regarding requests such as enrollment logs, missing documentation, and meeting arrangements.
Track and distribute safety reports, as applicable.
Attend project meetings and generate meeting minutes.
Assist in collecting ICH essential documents and ensuring the TMF is complete and appropriately maintained.
Assist in preparing project status reports for management review.
Maintain, update, and establish databases and metrics to support Sponsor oversight responsibilities.
Ensure appropriate documentation of identified site- and protocol-related issues.
Partner with the Clinical Research Associate (CRA) to ensure completeness and accuracy of the eISF and eTMF.
Facilitate postings and updates to ClinicalTrials.gov.
Perform other responsibilities as assigned.