Clinical Research Coordinator

4 weeks ago


Huntington Beach, United States CareerBuilder Full time

Overview:
NVISION Eye Centers is the leading ophthalmology partner comprised of the nations 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.

Responsibilities:
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 physicians time/schedule, and minimize patients appointment time
Oversee research patient visit schedule and modify doctors/tech/staffs 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

Qualifications:
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

Min:
USD $21.00/Hr.

Max:
USD $25.00/Hr.
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