Clinical Research Coordinator - Surgery​/Center Clinical Research Management

Clinical Research Specialist 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 Surgery Division of Trauma Critical Care and Burn; 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.

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

This is a patient facing position and the employee is required to be onsite. In addition, evenings, weekends, and on-call hours will be required, including holidays.