Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Department of Psychiatry and Behavioral Health; oversees, implements & coordinates conduct of daily activities of research studies; serves as primary reviewer of patient records to assess and identify patients who meet criteria for participation in research studies; recruits, interviews and promotes study to eligible patients; educates patients and families of purpose, goals, and processes of clinical study; leads patient enrollment activities and ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements; facilitates collection, processing & evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing; monitors 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 collecting, extracting, coding, and analyzing clinical research data; assists with activities to ensure compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; participates in planning, organizing and preparing for external compliance and quality assurance and control reviews; actively participates in internal quality assurance audits; participates in development of new research protocols and contributes to planning of goals to meet study requirements; assists with preparation and submission of publications, research reports, and grant proposals.
Minimum Education Required:
Bachelor’s Level Degree or equivalent combination of education and experience with a Major in biological sciences, health sciences or medical field.
Required Qualifications:
Bachelor’s Degree in biological sciences, health sciences or other relevant field or an equivalent combination of education and experience required; three to five years’ experience in a clinical research capacity conducting clinical research studies required; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in psychology and psychiatry preferred; clinical research certification from an accredited certifying agency required; 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: Research and Scholarship
Sub Function: Clinical Research
Career Band: Individual Contributor Series-Specialized
Career Level: S2
