Clinical Trial Associate

Axsome Therapeutics•New York, NY

13h•Hybrid

About The Position

Axsome Therapeutics is seeking a Clinical Trial Associate (CTA) that is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the Clinical Trial Manager (CTM), field based Clinical Research Associates (CRAs), and clinical study sites. This role will be a key study team member responsible for contributing to the life cycle of a clinical trial (all phases) and assure compliance with SOPs, FDA regulations, and ICH/GCP guidelines. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Requirements

Bachelor’s degree required.
Minimum 6 months - 1 year of relevant experience
Ability to work on site Monday, Tuesday & Thursday.
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

Nice To Haves

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

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