Clinical Research Coordinator-Clinical Trials Management Office

About the role

The Clinical Research Coordinator will coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Department of Internal Medicine/Division of Immunology and Rheumatology.

Responsibilities

• Assesses 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.
• Schedules and follows through with patient care appointments, procedures, & other diagnostic testing in accordance with study protocol.
• Collects, processes & evaluates biological samples.
• Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires.
• Maintains patient safety by monitoring for adverse reactions to study treatment, procedure or medication and notifying appropriate clinical professionals.
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies.
• Evaluates patients for compliance related to protocol.
• Collects, extracts, codes, and analyzes clinical research data.
• Generates reports and reviews to ensure validity of data.
• Maintains compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations.
• Collaborates with external parties to coordinate and prepare for external quality assurance and control reviews by IRB, federal or industry sponsors.
• Contributes to the development of new research protocols and establishes study goals to meet protocol requirements.

Requirements

• Minimum Education: Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
• Experience: One year experience in a clinical research capacity required.
• Preferred Experience: Experience or knowledge in inpatient clinical research 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.

Skills

• Computer skills required with experience using Microsoft Software applications.

Benefits

Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

Function/Subfunction

Research and Scholarship/Clinical Research

Career Band

Individual Contributor- Specialized

Career Level

S2

This position is patient facing and is required to be onsite at The Ohio State University Wexner Medical Center. Evenings, weekends, holidays, and on-call hours may be required as dictated by the clinical research activity. Some travel to other Ohio State University Wexner Medical Center outpatient sites may be required. Travel will be within the Columbus Metropolitan Area and may include Dublin, New Albany, Martha Morehouse, University Hospital, and Powell.