Senior Clinical Research Coordinator

Job Description 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 College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Division of Neuromuscular Diseases in the Department of Neurology; oversees, implements amp; 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 amp; administered in compliance to regulatory amp; sponsor requirements; facilitates collection, processing amp; evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, amp; 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, amp; provide appropriate level of care; documents unfavorable responses and notifies research sponsors amp; 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

Bachelors Degree in biological sciences, health sciences or medical field or an equivalent combination of education and experience required.

Required Experience and Certification

3-5 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 while in the job.

Preferred Experience and Skillset

Experience in a progressively responsible management capacity in a medical research environment preferred; experience or knowledge in Neuromuscular diseases / disorders 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