Ohio State University Wexner Medical Center
Senior Clinical Research Coordinator
Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43224
Overview
The Senior Clinical Research Coordinator
is a leadership position focused on ALS clinical trials and studies only. Responsibilities 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 (CCRM) for the Division of Neuromuscular in the Department of Neurology. Oversee, implement and coordinate conduct of daily activities of research studies. Serve as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies. Recruit, interview and promote study to eligible patients; educate patients and families of purpose, goals, and processes of clinical study; lead patient enrollment activities and ensure informed consent authorization is obtained and administered in compliance with regulatory and sponsor requirements. Facilitate collection, processing and evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, and other diagnostic testing. Monitor patients for adverse reactions to study treatment, procedure or medication and notify appropriate clinical professional to evaluate patient response, identify status of complications, and provide appropriate level of care. Document unfavorable responses and notify research sponsors and applicable regulatory agencies. Participate in collecting, extracting, coding, and analyzing clinical research data; assist with activities to ensure compliance with Institutional Review Boards (IRB), FDA, federal, state and industry sponsor regulations. Participate in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participate in internal quality assurance audits. Participate in development of new research protocols and contribute to planning of goals to meet study requirements; assist with preparation and submission of publications, research reports, and grant proposals. Minimum Education Required Bachelors Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required. Minimum Experience Required Three years experience in a clinical research capacity conducting clinical research studies required. 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. Skills and Qualifications Desired/Preferred Four to six years of clinical research experience preferred; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in neurological movement disorders preferred; computer skills required with experience using Microsoft Software applications desired. CAREER/STATUS: FUNCTION/SUBFUNCTION: Research and Scholarship/Clinical Research CAREER BAND: Specialized CAREER LEVEL: S3
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The Senior Clinical Research Coordinator
is a leadership position focused on ALS clinical trials and studies only. Responsibilities 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 (CCRM) for the Division of Neuromuscular in the Department of Neurology. Oversee, implement and coordinate conduct of daily activities of research studies. Serve as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies. Recruit, interview and promote study to eligible patients; educate patients and families of purpose, goals, and processes of clinical study; lead patient enrollment activities and ensure informed consent authorization is obtained and administered in compliance with regulatory and sponsor requirements. Facilitate collection, processing and evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, and other diagnostic testing. Monitor patients for adverse reactions to study treatment, procedure or medication and notify appropriate clinical professional to evaluate patient response, identify status of complications, and provide appropriate level of care. Document unfavorable responses and notify research sponsors and applicable regulatory agencies. Participate in collecting, extracting, coding, and analyzing clinical research data; assist with activities to ensure compliance with Institutional Review Boards (IRB), FDA, federal, state and industry sponsor regulations. Participate in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participate in internal quality assurance audits. Participate in development of new research protocols and contribute to planning of goals to meet study requirements; assist with preparation and submission of publications, research reports, and grant proposals. Minimum Education Required Bachelors Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required. Minimum Experience Required Three years experience in a clinical research capacity conducting clinical research studies required. 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. Skills and Qualifications Desired/Preferred Four to six years of clinical research experience preferred; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in neurological movement disorders preferred; computer skills required with experience using Microsoft Software applications desired. CAREER/STATUS: FUNCTION/SUBFUNCTION: Research and Scholarship/Clinical Research CAREER BAND: Specialized CAREER LEVEL: S3
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