Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management for the Division of Neuromuscular Diseases in the Department of Neurology; oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies; recruits, interviews and promotes study to eligible patients; educates patients and families of purpose, goals, and processes of clinical study; leads patient enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements; facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing; monitors patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in collecting, extracting, coding, and analyzing clinical research data; assists with activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.
Minimum Education and Skills/Experience Required/Desired
Bachelors Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required; three to five years experience in a clinical research capacity conducting clinical research studies required; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in Neuromuscular diseases and disorders preferred; clinical research certification from an accredited certifying agency required; computer skills required with experience using Microsoft Software applications desired. Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.
One of the largest centers for neuromuscular disorders in the United States
Forty years ago, Jerry Mendell, MD, an internationally known expert in Duchennes muscular dystrophy, founded what has grown into the Ohio State Neuromuscular Center, one of the largest nerve and muscle centers in the United States, focusing on excellent care for patients with nerve and muscle disease and state-of-the-art clinical and basic research. Our Neuromuscular Center serves our Neurological Institute, which brings together physicians, scientists, nurses and therapists to develop new technologies and better treatments for people with complex neurological conditions.
Researchers at our Neuromuscular Center have carried out hallmark research in Duchennes muscular dystrophy, have identified a critical mechanism in the pathology of dermatomyositis and are now involved in gene therapy trials for disorders including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS).
The Ohio State University is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. Founded in 1870, Ohio State is a world-class public research university and the leading comprehensive teaching and research institution in the state of Ohio. With more than 63,000 students (including 57,000 in Columbus), the Wexner Medical Center, 14 colleges, 80 centers and 175 majors, the university offers its students tremendous breadth and depth of opportunity in the liberal arts, the sciences and the professions.