- 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
- 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