Pre-Market Clinical Research Associate (CRA)

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)

• 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