CLINICAL RESEARCH COORDINATOR

3 weeks ago

New York NY USA, United States Columbia University Full time
* Job Type: Officer of Administration
* Regular/Temporary: Regular
* Hours Per Week: 35
* Salary Range: $62,400 - $65,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

Under the direction of the Director of the Clinical Trials Unit (CTU) and Principal Investigators, the Clinical Research Coordinator will conduct clinical research studies (industry-sponsored and investigator-initiated) 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.

Responsibilities

* 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, 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.
* Be able to coordinate and perform research testing and imaging for clinical research studies including but not limited to visual acuity, refraction, dark adaptation, visual field, microperimetry, fluorescein angiography, fundus photography, optical coherence tomography (OCT), ICG angiography, slit lamp photography, MP1, corneal mapping, specular biomicroscopy including confocal imaging, HRT Analyzer (glaucoma), and ERGs.
* Be able to administer surveys, such as the National Eye Institute Vision Function Questionnaire (NEI-VFQ-25), EuroQOL-5 Dimension, Reading speed, Health Utilities Index.
* 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.
* Obtain and maintain study certifications for ETDRS, OCT, and photography for clinical trials.
* Obtain access to sponsors' electronic data capture (EDC) systems, complete EDC trainings, and enter data into the EDC within 5 days of seeing the study patient.
* Maintain and organize study-related documentation and records using the EDC platforms, including capturing adverse events and serious adverse events and preparing for monitoring visits.
* Respond to all sponsor-related queries in a timely manner.
* Ensure that all aspects of Good Clinical Practice are 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.
* Work with the Regulatory Manager to gain CUIMC Institutional Review Board (IRB) approval in a timely manner by creating informed consent forms using sponsors' templates, responding to IRB correspondents, submitting amendments, renewals, modifications, and other regulatory documents required by the sponsor and FDA, including progress reports.
* Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of the study according to study-related protocols and 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, medical licenses, Conflict of Interest, HIPAA, and Human Subjects Trainings 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.

Minimum Qualifications

* Bachelor's degree or equivalent in education and experience, plus minimum of 1 to 2 years of related experience.
* Conform to all applicable HIPAA, billing compliance and safety requirements.
* 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.

Preferred Qualifications

* Working knowledge of Spanish
* Phlebotomy license
* Prior experience in ophthalmology

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

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