Clinical Trials Coordinator

University of Colorado•Aurora, CO

1d•Onsite

About The Position

The Virtual Hearing Lab of Dr. Vinaya Manchaiah, Professor and Director of Audiology in the Department of Otolaryngology, is seeking a Clinical Research Trials Coordinator for a part time (.5 FTE) position on the University of Colorado Denver Anschutz Medical Campus in Aurora, CO in the Department of Otolaryngology. The Virtual Hearing Lab is an interdisciplinary collaborative research initiative with the aim to improve hearing health access.

Requirements

Bachelor’s degree in any field
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
One (1) year clinical research or related experience
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
Outstanding customer service skills

Nice To Haves

Bachelor’s degree in science or health related field
Clinical research or related experience
Experience with electronic data capture systems

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies
Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order