Senior Clinical Research Coordinator

The Ohio State University • Columbus, OH

1d • Onsite

About The Position

Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Division of Multiple Sclerosis (MS) 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.

Requirements

• Bachelor’s Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required.
• 3-5 years' experience in a clinical research capacity conducting clinical research studies required
• Clinical research certification from an accredited certifying agency required (SOCRA or ACRP) and must be maintained while in the job.
• Requires successful completion of a background check.
• Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

Nice To Haves

• Experience in a progressively responsible management capacity in a medical research environment preferred
• Experience or knowledge in Neuromuscular diseases/disorders preferred
• Computer skills required with experience using Microsoft Software applications desired.

Responsibilities

• 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.

Benefits

• Eligible Ohio State employees receive comprehensive benefits packages, including medical, dental and vision insurance, tuition assistance for employees and their dependents, and state or alternative retirement options with competitive employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees