Clinical Trial Associate/Senior Clinical Trial Associate

Regulatory Toolkit; New York (NY); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits package

Job summary

Axsome Therapeutics in New York City is seeking a Clinical Trial Associate (CTA) or Senior CTA to support a diverse clinical trials portfolio across all phases. You will work with the CTM, CRAs and sites to ensure trials run smoothly and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

This on-site role requires at least three days in the office per week, with no fully remote options. The salary range is $60,000 to $80,000 plus a bonus, equity and a generous benefits package.

Qualifications

• Bachelor’s degree required; life science degree preferred.
• Minimum 1 year of relevant experience.
• On-site Monday, Tuesday & Thursday.

Responsibilities

• Create and maintain study trackers.
• Ensure accurate information in CTMS.
• Review and maintain documents in eTMF.
• Assist clinical study team during all trial phases.
• Coordinate site regulatory documents and IRB submissions.
• Distribute study materials to sites as directed.
• Support field-based CRAs and data management with data review.

Skills

Organizational skills

Team player

ICH/GCP knowledge

Multi-tasking

Education

Bachelor's degree

Job description

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. Please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is seeking a Clinical Trial Associate (CTA)/Senior Clinical Trial Associate (Sr. 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.

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

Salary and Benefits:

The anticipated salary range for this role is $60,000 - $80,000. 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.