Under the direction of the Director of the Clinical Trials Unit (CTU) and Principal Investigators, the Clinical Research Coordinator will oversee and conduct clinical research studies within the Columbia University Irving Medical Center (CUIMC) Department of Ophthalmology in adherence with assigned study protocols and manuals of operation and in accordance with clinical research principles.
Gain CUIMC Institutional Review Board (IRB) approval in a timely manner by initiating CUIMC IRB applications, creating informed consent forms using sponsors' templates, responding to IRB correspondents, submitting amendments, renewals, and other regulatory documents required by the sponsor and FDA.
Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of the study according to study-related protocols and ophthalmic manuals.
Work directly with sponsors' designated Clinical Research Organizations (CRO) to complete all required study start-up documents including FDA 1572 forms, investigator signatures, CVs, and medical licenses in a timely manner.
Complete feasibility forms requested by sponsors in a timely manner to assess ophthalmic equipment and examination rooms to conduct the studies.
Serve as the contact person for those interested in study participation and assist with recruitment activities including pre-screening electronic medical records for eligibility, contacting potential subjects, explaining all study procedures, and consenting eligible subjects or assenting parents or guardians for children enrolled in research studies.
Coordinate day-to-day aspects of study related procedures, including, but not limited to: scheduling visits and procedures, data entry, specimen collection, preparing for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, preparation for monitoring visits, site initiation/closeout visits and audits as needed.
Coordinate and perform research testing and imaging for clinical research studies as directed by principal investigators. These may include: visual acuity, dark adaptation, visual field, fluorescein angiography, fundus photography (stereo), optical coherence tomography, ICG angiography, slit lamp photography, MP1, corneal mapping, specular biomicroscopy including confocal imaging, HRT Analyzer (glaucoma), and ERGs.
Obtain and maintain study certifications for clinical trials.
Communicate regularly with the research team and responding to all correspondences in a timely manner.
Prepare for, schedule, and attend a study audit as requested by the Clinical Research Organizations of all study procedures.
Work with the research team and ocular photography department to ensure that all required eye exams and ocular testing are scheduled and completed according to protocol.
Maintain and organize study-related documentation and records using sponsor electronic data capturing platforms, including capturing adverse events and serious adverse events and preparing for audits by Clinical Research Organization.
Be able to administer surveys, such as the National Eye Institute Vision Function Questionnaire (NEI-VFQ-25).
Ensure that all aspects of Good Clinical Practice is followed at all times by developing and ensuring adherence with Standard Operating Procedure (SOP) for clinical studies being conducted in the Ophthalmology Clinical Trials Unit.
Bachelor's degree in a science discipline or equivalent in education, training plus two years of related experience
Must be able to work effectively with minimal supervision.
Prior research experience to include recruiting study participants, conducting standardized protocol visits and data entry.
Excellent verbal and written communication skills and attention to detail required.
Computer skills (Word, Excel) required.
Excellent interpersonal skills.
Willingness to travel to different sites.
Must successfully complete systems training requirements
Certified Clinical Trials Coordinator
Working knowledge of Spanish
Prior experience in ophthalmology
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 504516
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.