Clinical Trial Associate/Senior Clinical Trial Associate

New York, NY. Posted a month ago

The role

This person will support the development and implementation of clinical trials across the product portfolio. They will provide support to the Clinical Trial Manager, field based Clinical Research Associates, and clinical study sites.

What you will do

Create and maintain study trackers
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
Collect and review clinical study site essential regulatory documents
Submission and tracking of documents to central/local Institutional Review Board (IRB)
Distribute study materials to clinical study sites
Participate in meetings with internal and external stakeholders
Assist clinical study team in preparation and distribution of study documents and materials
Support field-based CRAs

Required qualifications

Bachelor's degree
Minimum 1 year of relevant experience
Ability to work on site Monday, Tuesday & Thursday
Good organizational skills
Be a team player
Function independently
Be able to interact comfortably with colleagues and external stakeholders
Comfortable multi-tasking in a fast-paced small company environment
Able to adjust priorities as needed
Willingness and ability to fill functional gaps in a small but growing organization

Nice to have

Life science degree
Basic understanding of ICH/GCP and clinical research terminology

Benefits

Annual bonus
Significant equity
Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine.