Lead Clinical Research Associate

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Aug 22, 2019
Ref
2019-4081
Hotbed
BioMidwest
Required Education
Associate Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a Lead Clinical Research Associate (CRA) who will manage CRAs within the assigned region in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting.

Responsibilities

  • Project Support
    • Ensuring harmonization of field and in-house monitoring practices.
    • Perform primary CRA role and associated CRA responsibilities for assigned trial site(s).
    • Performs co-monitoring, SWAT monitoring visits.
    • Provides back-up coverage for CRA outages / PTO.
    • Reviews CRA trip reports.
    • Performs CRA mentoring, training, metrics analysis.
    • Participates in continuous improvement initiatives for function or department.
  • Functional Management and Staff Development
    • Supports the implementation and execution of strategies employed by Clinical Operations staff to meet corporate goals or directives.
    • May establish, analyze and review appropriate metrics to ensure staff are compliant with goals and objectives.
    • May support the identification of training needs within function and the development of training materials to meet those needs. May provide mentoring or training as required to improve core competency and skill set of the function or region.
    • May participate and implement continuous improvement processes for function or organization.
    • May directly supervise staff, including training, development, hiring, discipline, and terminations.


Qualifications

  • A minimum of 1 year on-site monitoring experience.
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • Must have at least a bachelor's degree, preferably in a life science.
  • Master's degree preferred.
  • Approximately 50% overnight travel for meetings, oversight visits.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills as demonstrated at a management level.
  • Demonstrated computer skills (MS Office, MS PowerPoint, EDC, CTMS, IRWS and eTMF preferred).
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
  • Knowledge of GCP as it relates to clinical trial management.
  • Strong written and verbal communication skills; learn quickly; handle multiple studies and aggressive timelines.


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.

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