Remote opportunity at
Axsome Therapeutics, Inc.Clinical Trial Associate
Axsome Therapeutics, Inc. is a biopharmaceutical enterprise focused on central nervous system conditions, offering several FDA-approved medications and developing product candidates for neurological and psychiatric disorders.…
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About This Role
Axsome Therapeutics, Inc. is a biopharmaceutical enterprise focused on central nervous system conditions, offering several FDA-approved medications and developing product candidates for neurological and psychiatric disorders. The company is hiring a Clinical Trial Associate to aid in executing clinical trials across its development pipeline. This position requires working at the organization's headquarters in New York City on an in-person schedule of at least three days per week, specifically Mondays, Tuesdays,…
Job Description
Axsome Therapeutics, Inc. is a biopharmaceutical enterprise focused on central nervous system conditions, offering several FDA-approved medications and developing product candidates for neurological and psychiatric disorders. The company is hiring a Clinical Trial Associate to aid in executing clinical trials across its development pipeline.
This position requires working at the organization's headquarters in New York City on an in-person schedule of at least three days per week, specifically Mondays, Tuesdays, and Thursdays. Fully remote applicants cannot be considered for this opening. The Clinical Trial Associate partners closely with the Clinical Trial Manager, field-based Clinical Research Associates, and study sites to manage trial phases from feasibility through close-out while maintaining adherence to standard operating procedures, FDA regulations, and ICH/GCP guidelines.
The role involves maintaining study trackers, ensuring accurate data in the clinical trial management system, handling documents in the electronic trial master file, and collecting essential regulatory files from clinical study sites. Additional duties include managing Institutional Review Board submissions, distributing study supplies, supporting data management reviews, and drafting meeting records.
Responsibilities
- Create and maintain study trackers such as contact lists, status trackers, and specific checklists
- Keep information accurate and updated within the clinical trial management system
- Review and manage documents inside the electronic trial master file
- Assist the clinical study team through all trial phases including feasibility, start-up, maintenance, and close-out
- Collect and review clinical study site essential regulatory documents prior to site initiation and study drug release
- Submit and track documents to central and local Institutional Review Boards
- Distribute study materials to clinical study sites
- Participate in stakeholder meetings, prepare agendas, and draft meeting minutes
- Help prepare and distribute study documents and materials such as informed consent forms, regulatory binders, and patient recruitment items
- Support field-based Clinical Research Associates and assist data management with clinical data review
- Perform final reconciliation of the electronic trial master file during study close-out
Requirements
- Minimum of one year of relevant experience
- Must work on site in New York City on Mondays, Tuesdays, and Thursdays
- Strong organizational skills and ability to function independently
Qualifications
- Bachelor's degree required, with a preference for a life science degree
- Basic understanding of ICH/GCP and clinical research terminology preferred
Core Skills
Benefits
- Annual bonus
- Significant equity
- Generous benefits package
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary for the Clinical Trial Associate position?
The anticipated salary range is between $60,000 and $68,000 per year, determined by factors such as experience, qualifications, internal equity, and location.
Is this a remote position?
No, this role is not fully remote. It requires working on-site at the headquarters in New York City at least three days per week, specifically on Mondays, Tuesdays, and Thursdays.
What education is required for this role?
A bachelor's degree is required, with a preference for candidates who hold a life science degree.
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