Clinical Research Coordinator; HS

Overview

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Job Description Summary Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the Department of Orthopaedics; 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.

• Coordinate and perform daily clinical research activities in accordance with approved protocols administered by the Department of Orthopaedics.
• Assess patient records to identify patients who are eligible to participate in specified clinical research protocols; recruit, interview and enroll patients; obtain informed consent and ensure consent process complies with regulatory and sponsor requirements.
• Educate patients and families of purpose, goals, and processes of clinical study.
• Coordinate scheduling and follow-through of patient care appointments, procedures, and other diagnostic testing in accordance with study protocol.
• Participate in the collection, processing and evaluation of biological samples; administer, evaluate and calculate standardized scoring of diagnostic, psychological or behavioral testing or questionnaires.
• Monitor patients for adverse reactions to study treatment, procedure or medication; 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.
• Evaluate patients for compliance related to protocol; assist with collecting, extracting, coding, and analyzing clinical research data; generate reports and reviews to ensure validity of data.
• Support activities to ensure compliance with all IRB, FDA, federal, state and industry sponsor regulations; assist with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors.
• Participate in activities to develop new research protocols and contribute to establishment of study goals to meet protocol requirements.

• Bachelor’s Degree in biological sciences, health sciences or other medical field or an equivalent combination of education and experience required.
• One year experience in a clinical research capacity required; experience or knowledge in Orthopaedics 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.
• Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

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Thank you for your interest in working at Ohio State.

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

The university is an equal opportunity employer, including veterans and…