Clinical Trial Associate

Axsome Therapeutics; New York (NY); In loco; USD 60.000 - 68.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity

Generous benefits package

Descrizione del lavoro

Axsome Therapeutics is seeking a Clinical Trial Associate to support the lifecycle of clinical trials across its product portfolio. The role reports to the Clinical Trial Manager, supports field-based CRAs, and ensures compliance with SOPs, FDA regulations, and ICH/GCP guidelines.

The position is based at our HQ in New York City with an on-site requirement of at least three days per week. Responsibilities include creating trackers, maintaining CTMS/eTMF, assisting in study activities across all

Competenze

• Bachelor’s degree required; life sciences degree preferred.
• Minimum 1 year of relevant experience.
• On-site requirement: Monday, Tuesday & Thursday (no fully remote roles).

Mansioni

• Create and maintain study trackers and checklists.
• Ensure accurate data in CTMS and eTMF.
• Support clinical study team across all trial phases.
• Collect and review essential regulatory documents prior to site initiation.
• Submit and track documents to IRB for approvals.
• Distribute study materials to sites as directed.
• Prepare meeting agendas and minutes for stakeholder meetings.
• Assist with study documents and recruitment materials.
• Support field-based CRAs and data management tasks.
• Assist with final eTMF reconciliation during close-out.

Conoscenze

Organizational skills

Team player

Independent work

Stakeholder interaction

Formazione

Bachelor’s degree

Life sciences degree preferred

Strumenti

CTMS

eTMF

IRB systems

Descrizione del lavoro

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading 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, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

AxsomeTherapeutics isseekingaClinical Trial Associate (CTA)thatisresponsible forsupporting 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 atAxsome’sHQ 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.

Job Responsibilities and Duties

include, but are not limited to, the following:

• Create andmaintainstudy trackers (e.g., contact lists, study status trackers, study specific checklists.)
• Ensureaccurateand up to date information in clinical trial management system (CTMS)
• Review andmaintaindocuments in the Electronic Trial Master File (eTMF)
• Assistclinical 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 drugrelease
• Submission and tracking of documents to central/local Institutional Review Board (IRB)
• Distribute study materials to clinical study sites, asdirected
• Participate in meetings with internal and external stakeholders, draft meetingagendasand minutes, asneeded
• Assistthe clinical study team in preparation and distribution of study documents and materials (e.g., informed consent form, regulatory binder, patient recruitment materials, and newsletters)
• Supportfield-basedCRAs
• Assistdata management with review of clinical data asneeded
• Assistclinical study team with the final reconciliation of the eTMF during studyclose-out

Requirements/Qualifications

• Bachelor’s degreerequired.Preference to candidates with alifescience degree
• Minimum 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.

Experience and Knowledge

• 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).
• Basic understanding of ICH/GCP and clinical research terminologypreferred
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities asneeded
• Excellent teamplayer;willingness and ability to fill functional gaps in a small but growing organization
• Additionalskills/qualifications for the role, including any that are preferred but notrequired

Salary and Benefits:

The anticipated salary range for this role is $60,000 - $68,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.