Clinical Research Coordinator - NVISION Eye Centers

NVISION® Eye Centers is the leading ophthalmology partner comprised of the nation’s leading providers of ophthalmic physician services. Based in Aliso Viejo, California, the Company operates over 50 locations (clinics and ASCs). We strive to delight our patients by providing unrivaled care and service that exceeds their expectations. We are The Eye Doctors’ #1 Choice®.

• Ensure site readiness for new clinical trials:
• • Complete initial regulatory document submissions as required by Sponsor
  • Oversee the training and certification of all study staff
  • Create study source documents
  • Implement pre-screening process for potential candidates, if possible

• Perform study procedures in accordance with ICH-GCP regulations and study protocols, which can include, but is not limited to:
• • Consenting patients
  • Medication and adverse event review
  • Refraction
  • Imaging or testing
  • Lab collection, processing, and shipping – previous IATA training is a plus

• Analyze clinic flow in order to strategically use clinic workup rooms, properly make use of physician’s time/schedule, and minimize patient’s appointment time

• Oversee research patient visit schedule and modify doctors/tech/staff’s schedule to comply with visit window requirements

• Work collaboratively with the investigators, study vendors, Sponsors, and study monitors to ensure that trial is properly conducted, all data is correct and complete, and study timelines are met
• Discuss and inform study participants with PI to ensure patient safety and PI oversight
• Report adverse events/serious adverse events to Sponsor, following Sponsor required deadlines, and follow up as necessary
• Assess and maintain quality control of subject paper source, electronic subject data, and regulatory documents
• Cultivate enthusiastic and professional relationships with patients and sponsors alike

• Prior experience as a study coordinator is a MUST
• The position requires at least a high school diploma or equivalent, but individuals with college degrees are preferred.
• Must possess excellent clerical skills and good interpersonal skills
• Computer skills related to data management (including MS Office)
• Experience with electronic medical records (EMR) and other clinical software a plus
• Friendly attitude and people skills, with an emphasis on being a team player
• High degree of attention to detail and organizational skills
• Spanish-speaking a plus