Founded in 1887, the Indiana University School of Medicine Department of Urology is one of the oldest and most trusted urology departments in the country with world-renowned clinicians, educators and researchers in the areas of testis cancer, bladder cancer, prostate cancer, pediatric urology and stone disease as well as other urologic subspecialties.
The Clinical Research Coordinator will coordinate, manage, and participate in clinical research studies conducted by Indiana University School of Medicine Department of Urology investigators. Performs a variety of patient/subject related care and administrative duties to support activities that meet objectives of assigned research protocol(s). Sponsor support and training provided.
Provides subject screening, care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical principals.
Confers with study subjects to explain purpose of investigation. Explains diagnostic procedures, risk, and methods of treatment to patients and family. Obtain written consent from participants in study prior to initiation of any protocol procedures.
Coordinates screening, consenting and scheduling of test or exams of study subjects. Assist with and/or leads study initiation visits and monitoring visits by research sponsors.
Collects pertinent data from subjects, charts and interviews. Maintains research regulatory documentation for the department and individual study sponsor.
Completes case report forms (CRFs) in accordance with research guidelines. Reviews CRFs, source documentation and study files with representatives from sponsor or from the Food and Drug Administration (FDA). Make necessary corrections to CRFs and submit requested documentation in a timely manner.
Complies with standard operating procedures of institution review board (IRB). Submits reports, documents and correspondence as necessary to the IRB or sponsor.
Maintains current knowledge of regulations governing clinical research. Initiates and participates in problem solving discussions within a functional teamwork concept. Attends research meetings and conferences as required.
Bachelor's degree in science or health-related field; OR associate's degree in Allied Health professions/bachelor's degree in other fields and three years of experience in clinical research.
Clinical Research Certification (ARCP or SOCRA).
Knowledge of regulatory affairs and/or issues. Familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings. Ability to effectively communicate and exchange information.
Working Conditions / Demands
Good attendance, bending, minor lifting, carrying, reaching, twisting, writing, sitting, or standing for prolonged periods of time, talking, hearing, moving, and seeing. He/she will also work with lab equipment, word processors, and chemicals. Must be able to perform essential functions of the job with or without an accommodation.
Salary Plan: PAE
Salary Grade: 3RS
Job Function: Research
This posting is scheduled to close at 11:59pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.