Senior Clinical Research Coordinator - CCC | Clinical Trials Office

Position Summary

Senior Clinical Research Coordinator serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the Clinical Trials Office (CTO) Multi-Center Trial Program (MCTP); oversees & coordinates conduct of daily activities of research studies; serves as primary reviewer of subsite patient records to assess and identify patients who meet criteria for participation in research studies; ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements; oversees the collection, processing & evaluation of biological samples, as well as follow-through of patient care appointments, procedures, & other diagnostic testing; monitors subsite 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; ensure the site documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in 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.

Job Requirements

Bachelors 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; experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in specialty area preferred; clinical research certification from an accredited certifying agency required; computer skills required with experience using Microsoft Software applications desired.