Clinical Research Associate

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 07, 2018
Ref
2018-2416
Hotbed
BioMidwest
Required Education
Associate Degree
Position Type
Full time
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. 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 protect patient safety and ensure data integrity.

Responsibilities

  • Coordinate Clinical Trials including activities such as:
  • Visiting trial sites regularly
  • Acting as liaison between project managers and research-site personnel
  • Maintaining the quality of the work and relationships
  • Monitoring the conduct of clinical trials and compliance with established timelines
  • Ensuring harmonization of in-house monitoring practices
  • Ensure Quality Assurance of projects including:Adhering to protocol regulatory requirements
  • Good clinical practice regulations, and standard operating procedures
  • Assessing the trial site and applicable personnel on an ongoing basis
  • Ensuring compliance with the patient-consent process
  • Verifying the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation
  • Verifying compliance and quality of collected data
  • Ensuring compliance with the procedures to apply in the event of serious adverse events
  • Drafting an appropriate intervention plan for the avoidance of redundant errors and deviations
  • Verifying investigator records and checks for consistency with the contents of sponsor files
  • Assesses site qualification potential: reviews study requirements; conducts pre-study visits and drafts pre-study evaluation reports.
  • Participates in the implementation of clinical.
  • studies: communicates with investigators and their staff; ensures compliance with terms and conditions; properly trains site personnel and writes initiation visit reports.
  • Supervises the conduct of clinical studies: acts as liaison between site personnel and the sponsor; performs monitoring in the field; ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.
  • Ensures the quality of the project: verifies materials and data integrity; assists site personnel with internal audits or regulatory inspections; and perform ongoing follow-up with the in-house project team.
  • Closes clinical studies: verifies the integrity of investigator files; ensures availability of clinical and non-clinical materials; jointly reviews with investigators the obligations inherent at the end of the study and writes closure visit reports.


Qualifications

  • 5 years' experience as an on-site CRA/full-site manager that has completed all types of monitoring visits. This cannot be someone that's only ever been an in-house CRA or who was a SWAT CRA that only did pre-study visits.
  • Experience with multiple eCRF platforms, CTMS, eTMF a plus
  • Prefer candidates with previous experience in complex therapeutic indications; pediatrics a plus
  • Must have at least a bachelor's degree, preferably in a life science.
  • Must be available to travel 75-80%.
  • Must have 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.