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.
Primary Duties and Responsibilities:
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.
Approximately 40% of the duties of this position will be predetermined or structured according to Department and/or University policies, procedures, and protocols. 60% of the duties of this position will require the employee to make decisions that will affect outcomes. These decisions center around participant recruitment and retention, team dynamics, study visits, specimen collections and shipments and study coordination.
The level of job complexity for this position is typically moderate but may be high at times. The position may assist the Principal Investigators in creating or implementing policies, procedures, and protocols that impact the individual programs. This individual will also be required to handle complicated or urgent matters involving patient care or service recovery that require quick thinking, sound independent judgment, and tact. Good communication skills and teamwork are imperative. The overall scope of influence for this position is within the Department of Urology.
Bachelor's degree in science or a 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. Ability to maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
Working Conditions / Demands
Must be able to perform the essential duties and functions of the job with or without accomodation. The person in this role will need to communicate effectively, use a computer for extended periods of time, and work with lab equipment and chemicals.
Equipment utilized: Various lab and clinical equipment, and a computer.
Salary Plan: PAE
Salary Grade: 3RS
Job Function: Research
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
This posting is scheduled to close at 11:59 pm 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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Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment without regard to age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information .
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About Indiana University Purdue University Indianpolis - IUPUI
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.