Clinical Research Coordinator

Overview

NVISION® Eye Centers is one of the largest ophthalmology providers in the U.S., with over eighty centers across six states including California, Nevada, Oregon, Arizona, Texas, and Utah. An innovative leader in ophthalmology, we are dedicated to providing the best patient experience through the use of the latest technology and treatment by the most talented and experienced surgeons in the industry. With more than 3,000 eye doctors referring their patients and trusting their own eyes to NVISION surgeons, NVISION Eye Centers is the Eye Doctors' #1 Choice®.

Responsibilities

• The Clinical Research Coordinator will complete all study related procedures and distribute study medication and instructions to research subjects under the direction of the Lead and the Principal Investigator
• Maintain accurate, confidential files and documentation of study participants.
• The Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
• Obtains detailed knowledge of all components of each study protocol through review of study information with Lead prior to the effective date of the study.
• Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Reviews with Lead and Principal Investigator, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manages studies with direct oversight from Lead, and Principal Investigator to ensure compliance with protocol requirements.
• Manages studies with Lead and Principal Investigator to develop effective programs for study enrollment.
• Contribute to the SOP review and development as delegated by the Lead
• Perform study activities as delegated by the Principal Investigator and under the supervision of the Lead
• Attends the investigator meeting for each assigned protocol, as appropriate with directive from Lead
• Will work with Lead and Principal Investigator to ensure adherence to the study protocols and document AE's and protocol violations with sponsors and other outside regulatory organizations, as required
• Screen, enroll subjects and schedule subject visits
• Review and obtain informed consent form with potential candidate
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations, as required
• Maintain, organize, complete accurate study records
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects
• Enter data as appropriate for study protocol (paper/electronic data capture)
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol
• Perform study close-out procedures
• Store study records appropriately

Qualifications

• Able to communicate with investigator, providers, co-workers, sponsors, and others in a courteous manner.
• Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the study protocols, regulatory requirements, and company policy.
• Understands regulatory requirements, as well as Good Clinical Practices (GCP)
• Excellent communication skills (interpersonal, written, verbal)
• Basic computer skills to include Word, Excel, as well as EDC applications unique to clinical research industry