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About the Role

Axsome Therapeutics is seeking a Senior Clinical Research Associate to manage and monitor clinical trial sites, ensuring compliance with protocols, GCP, and regulatory requirements. This field-based role covers Texas and requires candidates to reside within the specified geography.

Responsibilities

• Assist with the execution and 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 protocol adherence and proper study conduct by sites.
• Create thorough monitoring visit reports.
• Act as the primary point of contact for assigned investigational sites and cross-functional teams, escalating issues as necessary.
• Perform and potentially lead in-house review of clinical data listings for completeness and accuracy, escalating issues as needed.
• Verify essential documents and study newsletters are present in the Investigator Site File and track/report recruitment updates for 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.
• Maintain completion of required corporate training on standards, policies, and work instructions.
• May conduct CRA assessments and complete thorough assessment reports.
• May act as a Lead CRA (LCRA) to support the development/review of clinical study plans, presentations, or project/study-related documents related to monitoring activities, including assisting the study team with day-to-day management of clinical studies.
• May act as a LCRA to track site performance metrics and provide oversight of CROs, internal/contract CRAs, and vendors, serving as a liaison for cross-functional teams.
• May act in a LCRA role capacity to be responsible for the management of Monitoring Visit Report (MVR) review, resolution, and escalation.
• May act in a LCRA role to train, mentor, or supervise junior-level staff.
• May participate in co-monitoring and/or training visits with team members for training purposes.
• Perform other work-related duties as assigned under the direction of the Clinical Trial Manager or Director.
• Undertake additional responsibilities as assigned.

Requirements

• Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting, including 5+ years of on-site monitoring experience.
• Demonstrate core understanding of medical terminology or clinical trial activities.
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines.
• Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision.
• 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.
• Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Willingness to travel up to 70%.

Skills

• Experience in interactions with outside vendors, e.g., CROs and other vendors preferred.
• Experience in CNS preferred.
• Proficiency in Microsoft Office, CTMS, eTMF, and eCRF platforms and organization tools.
• Problem-solving skills.
• Leadership skills.
• Attention to detail.
• Organizational abilities.
• Excellent written communication skills.
• Excellent oral communication skills.
• Presentation skills.
• Interpersonal skills.
• Communication skills (both written and oral).
• Self-motivated.
• Adaptable to a dynamic environment.

Location

• Texas

Work Type

• Field-based
• Full-time

Experience Level

• Senior

Education Level

• BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required.

About the Company

• 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.