Clinical Research Coordinator

The Ohio State University

21h • Remote

About The Position

Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Department of Obstetrics and Gynecology Maternal Fetal Medicine Clinical Research Team; assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring 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 evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.

Requirements

• Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
• 1 year of relevant experience required.
• 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

• 2-4 years of relevant experience preferred.
• Experience or knowledge in specialty area preferred
• Knowledge of medical terminology desired
• Clinical research certification from an accredited certifying agency desired
• Computer skills required with experience using Microsoft Software applications desired.

Responsibilities

• Coordinate and perform daily clinical research activities in accordance with approved protocols
• Assist with assessing patient records to identify eligible patients
• Recruit, interview, and enroll patients
• Obtain informed consent
• Educate patients and families about the study
• Coordinate patient care appointments and procedures
• Participate in the collection, processing, and evaluation of biological samples
• Administer and evaluate diagnostic, psychological, or behavioral testing
• Monitor patients for adverse reactions and notify appropriate clinical professionals
• Document unfavorable responses and notify research sponsors and regulatory agencies
• Evaluate patients for compliance related to protocol
• Assist with collecting, extracting, coding, and analyzing clinical research data
• Generate reports and reviews to ensure data validity
• Support activities to ensure compliance with IRB, FDA, and other regulations
• Assist with coordinating and preparing for external quality assurance reviews
• Participate in activities to develop new research protocols and contribute to study goals

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: Part-time
• Career Level: Mid Level