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:
Axsome Therapeutics is seeking a Senior Clinical Research Associate. Reporting to the Senior Manager of Clinical Monitoring, the Senior CRA 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.
This is a field-based position covering Texas. Candidates must reside within the geography.
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
- Responsible for verifying essential documents and study newsletters are present in the Investigator Site File and tracking/reporting of 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
- 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 the day-to-day management of clinical studies
- May act as a LCRA to track site performance metrics and provide oversight of CROs, internal /contract CRA(s) and vendors, including being a liaison for cross-functional teams
- May act in a LCRA role capacity to be responsible for the management of the Monitoring Visit Report (MVR) review, resolution, and escalation
- May act in a LCRA role, to be responsible for training, mentoring, or supervising 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 and under the direction of the Clinical Trial Manager or Director
- Additional responsibilities as assigned
Requirements / Qualifications
- Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting (including 5+ years on-site monitoring experience)
- BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but not required
- 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, required
- 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%)
Experience and Knowledge:
- Experience in interactions with outside vendors, e.g., CROs and other vendors preferred
- Experience in CNS preferred
- Computer skills including proficiency in the use of Microsoft Office, CTMS, eTMF and eCRF platforms and organization tools
- Demonstrate problem solving and leadership skills
- Solid attention to detail with proven organizational abilities, and excellent written and oral communication and presentation skills
- Solid interpersonal skills and communication skills (both written and oral)
- Self-motivated and adaptable to a dynamic environment