Clinical Trial Associate jobs in United States
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Axsome Therapeutics, Inc. · 6 hours ago

Clinical Trial Associate

Axsome Therapeutics is a biopharmaceutical company focused on treating central nervous system conditions. They are seeking a Clinical Trial Associate to support the development and implementation of clinical trials, ensuring compliance with regulations and assisting the clinical study team throughout all phases of the trial.

BiopharmaBiotechnologyTherapeutics

Responsibilities

Create and maintain study trackers (e.g., contact lists, study status trackers, study specific checklists.)
Ensure accurate and up to date information in clinical trial management system (CTMS)
Review and maintain documents in the Electronic Trial Master File (eTMF)
Assist clinical study team during all phases of clinical trial activities (e.g., feasibility, start-up, maintenance, and close-out)
Collect and review clinical study site essential regulatory documents prior to site initiation/study drug release
Submission and tracking of documents to central/local Institutional Review Board (IRB)
Distribute study materials to clinical study sites, as directed
Participate in meetings with internal and external stakeholders, draft meeting agendas and minutes, as needed
Assist the clinical study team in preparation and distribution of study documents and materials (e.g., informed consent form, regulatory binder, patient recruitment materials, and newsletters)
Support field-based CRAs
Assist data management with review of clinical data as needed
Assist clinical study team with the final reconciliation of the eTMF during study close-out

Qualification

Clinical Trial ManagementICH/GCP GuidelinesLife Science DegreeOrganizational SkillsMulti-taskingRegulatory KnowledgeTeam Player

Required

Bachelor's degree required
Minimum 6 months - 1 year of relevant experience
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Must have good organizational skills, be a team player, function independently, and be able to interact comfortably with colleagues and external stakeholders (e.g., study vendors, clinical study sites)
Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities as needed
Excellent team player; willingness and ability to fill functional gaps in a small but growing organization

Preferred

Preference to candidates with a life science degree
Basic understanding of ICH/GCP and clinical research terminology preferred

Benefits

Annual bonus
Significant equity
Generous benefits package

Company

Axsome Therapeutics, Inc.

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Axsome Therapeutics, Inc.

Funding

Current Stage
Public Company
Total Funding
$1B
2025-05-13Post Ipo Debt· $570M
2023-06-28Post Ipo Equity· $225M
2019-12-23Post Ipo Equity· $200M

Leadership Team

H
Herriot Tabuteau
Chief Executive Officer
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