Clinical Research Coordinator (HS)- Neurological Surgery

The Ohio State University

11d • Onsite

About The Position

Clinical Research Coordinator to 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 Neurological Surgery Human Gene Therapy 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 an equivalent combination of education and experience required.
• One year experience in a clinical research capacity required.
• Requires successful completion of a background check.

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

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