"Clinical Research Coordinator"

Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for the Department of Neurosurgery 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.

Bachelor's Level Degree or equivalent combination of education and experience with a Major in allied medicine professions or biological sciences

One year experience in a clinical research capacity conducting clinical research studies required.

Experience or knowledge in Neurosurgery 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