
Ohio State University
Description
The Ohio State University sets the stage for academic achievement and innovation. It's where friendships are forged, tradition is brought to life and a better global community is built. Our mission is as clear today as it was 150 years ago: to illuminate a pathway to education, research and health care that creates vibrant futures.
Roles and Responsibilities
- Senior Clinical Research Coordinator who serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Division of Endocrinology, Diabetes and Metabolism within the Department of Internal Medicine.
- 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 Required
- Bachelor's Level Degree or equivalent combination of education and experience with a Major in biological sciences and 4 years of relevant experience.
Required Qualifications
- Bachelor’s Degree in biological sciences health sciences or other relevant field or an equivalent combination of education and experience required. 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 gynecology and/or oncology preferred clinical research certification from an accredited certifying agency required Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical including a drug screen.