Clinical Research Coordinator-IRP

Job Summary:

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)Clinical Trials Management Organization for The Department of Obstetrics and Gynecology Maternal Fetal Medicine; 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, amp; other diagnostic testing in accordance with study protocol; participates in the collection, processing amp; 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, amp; provide appropriate level of care; documents unfavorable responses and notifies research sponsors amp; 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.

Minimum Education Required:

Bachelors Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.

Experience Required:

1 year of relevant experience required.

Preferred Experience:

2-4 years of relevant experience preferred.

Preferred Qualifications and Skills:

Experience or knowledge in maternal fetal medicine and general OB/GYN 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.

FUNCTION/SUBFUNCTION: Research and Scholarship/Clinical Research

CAREER BAND: Individual Contributor-Specialized

CAREER LEVEL: S2

This position will require various hours which will include evenings, weekends, and holidays as needed.