Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.

About This Role:

Axsome Therapeutics is seeking a Senior Clinical Research Associate. The Senior Clinical Research Associate will be responsible for site management and monitoring activities at assigned sites across assigned programs ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.

Job Responsibilities and Duties include, but are not limited to, the following:

• Assist with the execution and the timely implementation of clinical research activities for assigned projects
• Perform clinical monitoring activities (site evaluation, initiation, interim monitoring visits, remote and close-out) and provide overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Monitor investigative sites and activities to verify the protocol is being followed and study activities are being performed by sites
• Create thorough monitoring visit reports
• Act as primary point of contact for assigned investigational sites and cross functional teams and escalate to the study team as necessary
• Perform and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the Lead CRA or CTM and Study Director as needed
• Verify that essential documents and study newsletters are present in the Investigator Site File and track and report recruitment updates for their assigned sites
• Participate in the evaluation and training of investigative sites
• Assist with the organization and management of internal team meetings, investigator meetings, and other trial specific meetings as required
• Maintain completion of required corporate training on standards, policies, and work instructions
• Support the development/review of clinical study plans, presentations or project/study-related documents related to monitoring activities, including assisting the study team with the day-to-day management of clinical studies
• Track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams

Requirements / Qualifications

• BA/BS or equivalent degree required. BA/BS in a scientific discipline or related healthcare field is preferred
• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
• Demonstrated core understanding of medical terminology or clinical trial activities required
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, required
• Must live in Texas and be willing to travel (up to 70%)

Experience and Knowledge

• Experience in interactions with outside vendors, e.g., CROs and other vendors preferred
• Experience in CNS preferred
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
• Solid attention to detail with proven organizational abilities, and excellent written and oral communication and presentation skills
• Excellent team player with team building skills willingness and ability to fill functional gaps in a small but growing organization
• Ability to establish priorities, excellent sense of urgency and desire to collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
• Demonstrate problem solving and leadership skills
• Self-motivated and adaptable to a dynamic environment
• Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities

Salary & Benefits

The anticipated salary range for this role is $115,000 - $135,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. 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.