Reports to: Director, Clinical Operations
Sr. / Clinical Research Associate (West Coast)
Axsome Therapeutics (Axsome) is currently searching for a west coast based Clinical Research Associate to support our exciting clinical development programs. We are a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. By focusing on this therapeutic area, Axsome is addressing growing markets where current treatment options are limited or inadequate. Axsome has a balanced portfolio of clinical development stage as well as research stage product candidates. Axsome is located in New York City. For further information on Axsome, please visit our web site at www.axsome.com.
The ideal candidate is based in the Mountain or West Coast time zones. Preference will be given to candidates with senior-level experience.
The 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. Additional responsibilities will include in-house data review and occasionally leading the planning and development of study set-up.
Study Planning and Conduct:
- Lead and execute the timely implementation of clinical research activities for assigned projects.
- Performs clinical monitoring activities (site selection, initiation, interim monitoring visits and close-out) and provides overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
- Acts as primary point of contact for assigned investigational sites and cross functional teams and escalates to the study lead as necessary
- Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including contracts/site payments
- Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT
- Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the CTM or above as needed
- Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates
- Participates in the selection, training, and evaluation of investigative sites, study personnel (contractors, CRO, internal) and third party vendors.
- Assists with providing oversight of CROs, contract CRA(s) and vendors, including managing cross-functional teams
- Reviews monitoring trip reports and track resolution of all action items
- May participate in co-monitoring and/or training visits with junior team members for training purposes
- Collaborates with internal cross functional teams to ensure effective delivery of the assigned project milestones and corporate objectives and goals
- Assists with the organization and management of internal team meetings, investigator meetings, and other trial specific meetings as required
- Maintains completion of required corporate training on standards, policies and work instructions
- Performs other work-related duties as assigned and under the direction of the Clinical Trial Manager or Director
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required
- Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
- Solid attention to detail and excellent organization skills
- Solid interpersonal skills and communication skills (both written and oral)
- Excellent team player; 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
- Demonstrates 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
- Willingness to travel (up to 70%)
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
Education and Experience Requirements:
- BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but is not required
- Minimum of 3 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 1+ years on-site monitoring experience)
- Demonstrates core understanding of medical terminology or clinical trial activities
- Experience in interactions with outside vendors, e.g., CROs and other vendors is preferred
- Experience in CNS preferred