Clinical Research Coordinator-Clinical Trials Management Office

Job Summary

Clinical Research Coordinator 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 Gastro/Hepatology/Nutrition Division in the Department of Internal Medicine working on Inflammatory Bowel Disease (IBD) clinical research studies.

Responsibilities

• 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
• Schedules and follows through with patient care appointments, procedures, & other diagnostic testing in accordance with study protocol
• Collects, processes & evaluates biological samples
• Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires
• Makes sure patients are monitored for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professionals
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies
• Evaluates patients for compliance related to protocol
• Collects, extracts, codes, and analyzes 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
• Coordinates and prepares for external quality assurance and control reviews by IRB, federal or industry sponsors
• Participates in developing new research protocols and contributing to the establishment of study goals to meet protocol requirements

Requirements

• Minimum Education Required: Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
• Minimum Experience Required: One year experience in a clinical research capacity required.

Skills and/or Experience Preferred

• Experience or knowledge in inflammatory bowel diseases such as Crohn's
• Knowledge of medical terminology desired
• Clinical research certification from an accredited certifying agency desired
• Computer skills required with experience using Microsoft Software applications desired