Pre-Market Clinical Research Associate (CRA)

Dallas, TX

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Job Description

Job Description

  • Seeking a clinical research monitor/medical device rep to support device in the Operating Room and collect clinical study data/forms 
  • Must be able to attend all surgical cases
    • Confirm final inclusion/exclusion criteria
    • Intraoperative randomization
    • Data collection
    • Capture of images
  • Will work with experienced study coordinators at the sites
  • Understand how device works & # of sequences required for successful case
  • Experience in proctoring
  • Availability critical- must be able to travel weekly for ~4 to 6 month enrollment period, then will transition to remote monitoring and occasional site visits
  • Monitor support on OR surgical case day then QC next day
  • Follow-up & monitoring after 30 day visit will be remote: 3, 6 , 12, 18, 24 months (electronic forms: PROs, con-meds)
  • After 30 day  endpoint- will increase site assignments and monitor via electronic data capture (EDC)

Skills & Requirements

  • EXPERIENCE AND QUALIFICATION

    • Bachelor's Degree
    • Experience: Three (3) to five (5) years minimum experience conducting clinical trials on the sponsor side.  Experience in a medical device company preferred.
    • License/Certification(s): CRA or CRC, preferred
    • OR experience, Urology a plus, but not necessary
    • EDC experience

    Skills/Abilities:

    • Excellent organizational skills
    • Strong scientific/clinical background with ability to work independently.
    • Strong communication skills via telephone and email.
    • Proficient Microsoft Office and database applications skills.
    • Knowledge of Medical Devices Standards and Regulations (21 CFR Parts 11, 50, 54, 803, 812, 814, 822, 820; ICH GCP, 45 CFR Part 46; ISO 13485; and any other applicable regulations)
    • CITI training/cert a plus