Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to revolutionize neuropsychiatric care by utilizing neurobiology to develop personalized and highly effective treatment options. We are currently looking for a Clinical Trial Assistant (CTA) who will be responsible for providing support to the study team. This includes creating, distributing, maintaining, and organizing study materials, tools, and documents to ensure clinical trials comply with protocol requirements, SOPs, and ICH GCP Guidelines. In addition, the CTA will be responsible for providing general administrative support to the Clinical Operations Department.
DUTIES AND RESPONSIBILITIES:
Job Identifier: #4542
DUTIES AND RESPONSIBILITIES:
- 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.
- Coordinate vendor supplies and track 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 collecting 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.
- At least 3 years of industry experience or a 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
- Risk-based monitoring (RBM) experience is a plus
- Working with trials conducted globally is a plus
- 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
Job Identifier: #4542
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Mix Talent by 2x
See who you knowGet notified about new Clinical Trial Assistant jobs in Los Altos, CA.
Sign in to create job alertSimilar Searches
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub