• Clinical Research Associate

    Job Locations US-Remote
    Posted Date 2 weeks ago(2/6/2019 4:00 PM)
    Job ID
    2019-2972
    # of Openings
    1
    Category
    Clinical Operations
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking a Clinical Research Associate who will be responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. 

    Responsibilities

    • Project Support
      • Acts as primary liaison for assigned study sites to convey project information, answer questions and resolve site-related issues in accordance with the clinical monitoring plan
      • Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and applicable SOPs
      • Attends Investigator Meetings and study-specific training for assigned trials
      • Knowledgeable of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites
      • Collaborates with the CTOM to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics
      • Completes pre-study qualification visits, site initiation visits, routine monitoring and close-out visits within established timelines, documents activities in reports and as applicable in accordance with applicable SOPs and plans
      • Develops and maintains collaborative working relationships with clinical investigative sites
      • Communicates with investigators and their staff; ensures compliance with contractual terms and conditions; properly trains site personnel
      • Assures the trial site adequacy and applicable personnel qualifications on an ongoing basis
      • Accountable for data integrity, patient safety and regulatory compliance for all assigned sites
      • Monitors recruitment and data quality while on site and remotely through EDC systems and communication with sites
      • Responsible for ongoing data review and source data verification to study-specific targets and deadlines
      • Performs on-site drug accountability, reconciliation, and return, when applicable. Verifies trial product receipt, handling, accounting, and storage meets protocol requirements
      • Maintains current Investigator Site Files (ISF) in accordance with applicable SOPs and study Trial Master File (TMF) plans. Performs ongoing review of the ISF to assure quality of the documentation and compliance with applicable SOPs, GCP and ICH Guidelines while on site.  Submits documents as required to the TMF and reconciles ISF with TMF to ensure completeness
      • Assists the study team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation
      • Prepares, collaborates and implements corrective action plans with investigative sites with oversight from Clinical Trial Operations Manager (CTOM)
      • Attends site audits according to the Audit Management Plan and executes audit action plans with support from CTOM as appropriate
      • Assures adequate and appropriate dissemination of information between project team members to ensure project success
    • Functional Support
      • May perform CRA mentoring, training, review trip reports
      • May participate in continuous improvement initiatives for function or department
      • May identify training needs, develop training materials to meet those needs, and provide training as required to improve competency and skill set of the function (this includes sharing of lessons learned and best practices across the project team members and/or Clinical Operations)
    • Administration
      • Ensures compliance with the application of all applicable AveXis policies, procedures, and fundamentals

    Qualifications

    • 2 years on-site monitoring experience.
    • 4 years progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
    • Bachelor’s degree, preferably in a life science.
    • Demonstrated computer skills (MS Office, MS PowerPoint, EDC, CTMS, IRWS and eTMF preferred).
    • Overnight travel 50 – 80%.
    • Knowledge of GCP as it relates to clinical trial management.
    • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
    • Strong written and verbal communication skills; learn quickly; handle multiple studies and aggressive timelines.
    • Great team player.

     

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

     

    #LI-EC1

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed