Senior Clinical Research Associate (Texas Region)

Axsome Therapeutics•Austin, TX

4d•Remote

About The Position

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.

Requirements

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 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

Nice To Haves

Experience in CNS preferred

Responsibilities

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