Clinical Trial Associate

Axsome Therapeutics is a biopharmaceutical company focused on developing CNS therapies and advancing a neuroscience product portfolio and pipeline. The Clinical Trial Associate supports the successful execution of clinical trials across all phases by partnering with the Clinical Trial Manager, CRAs, and study sites while ensuring compliance with SOPs, FDA regulations, and ICH/GCP guidelines.

• Create and maintain study trackers (e.g., contact lists, study status trackers, study-specific checklists).
• Ensure clinical trial management system (CTMS) information is accurate and up to date.
• Review and maintain documents in the Electronic Trial Master File (eTMF).
• Support clinical trial activities across all phases (feasibility, start-up, maintenance, close-out).
• Collect and review essential regulatory documents prior to site initiation/study drug release.
• Submit and track documents to central/local Institutional Review Board (IRB).
• Distribute study materials to clinical study sites as directed.
• Participate in internal/external meetings; draft agendas and minutes as needed.
• Prepare and distribute study documents/materials (e.g., informed consent forms, regulatory binders, recruitment materials, newsletters).
• Support field-based Clinical Research Associates (CRAs).
• Assist data management with review of clinical data as needed.
• Support final reconciliation of the eTMF during study close-out.

• Bachelor’s degree required (life science degree preferred).

• Minimum 6 months to 1 year of relevant experience.

• Good organizational skills; team player; ability to work independently and interact with internal colleagues and external stakeholders (e.g., vendors, clinical sites).

• Basic understanding of ICH/GCP and clinical research terminology preferred.

• Ability to multitask in a fast-paced, small company environment and adjust priorities as needed.

• Willingness and ability to fill functional gaps in a growing organization.

• On-site role based at company headquarters with a requirement of at least 3 days per week on-site.

• Must be able to work on-site Monday, Tuesday, and Thursday; fully remote candidates will not be considered.

• Compensation includes annual bonus, significant equity, and a generous benefits package.