Senior 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 & Behavioral Health in partnership with the College of Medicine (COM) Center for Clinical Research Management; oversees, implements & coordinates conduct of daily activities of research studies; recruits, interviews and promotes study to eligible participants; educates participants and families of purpose, goals, and processes of clinical study; leads participant 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 study visits, procedures, & other testing; monitors participants for adverse reactions to study procedures and notifies appropriate clinical professional to evaluate participant 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 and Skills/Experience Required
Bachelor’s Degree in biological sciences, health sciences or medical 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. Clinical research certification from an accredited certifying agency required (SOCRA or ACRP) and must be maintained.
Experience/Skills Preferred
Experience in a progressively independent management capacity in a medical research environment preferred; experience or knowledge in psychiatry/behavioral health and imaging clinical research preferred; 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: S3
Regular 40 First Shift
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