Senior Clinical Research Coordinator

The Ohio State University

185d

About The Position

The Senior Clinical Research Coordinator is a leadership position focused on ALS clinical trials and studies only. The Sr. CRC 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 (CCRM) for the Division of Neuromuscular 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.
• Three years’ experience in a clinical research capacity conducting clinical research studies required.
• Clinical research certification from an accredited certifying agency required.
• Successful completion of a background check.

Nice To Haves

• 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.

Responsibilities

• Oversee, implement & coordinate conduct of daily activities of research studies.
• Serve as primary reviewer of patient records to assess and identify patients for participation in research studies.
• Recruit, interview and promote study to eligible patients.
• Educate patients and families about the purpose, goals, and processes of clinical study.
• Lead patient enrollment activities and ensure informed consent authorization is obtained & administered.
• Facilitate collection, processing & evaluation of biological samples.
• Schedule and follow-through of patient care appointments, procedures, & other diagnostic testing.
• Monitor patients for adverse reactions to study treatment, procedure or medication.
• Document unfavorable responses and notify research sponsors & applicable regulatory agencies.
• Participate in collecting, extracting, coding, and analyzing clinical research data.
• Assist with activities to ensure compliance with IRB, FDA, federal, state and industry sponsor regulations.
• Participate in planning, organizing and preparing for external compliance and quality assurance 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.

Benefits

• Comprehensive benefits packages, including medical, dental and vision insurance.
• Tuition assistance for employees and their dependents.
• State or alternative retirement options with competitive employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree