Initiates, conducts, completes, and reports clinical research studies. Identifies and selects potential research study subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s). Oversees and ensures compliance with protocol, regulatory, standard operating procedures, and Good Clinical Practices. Develops solutions to complex problems that impact the timeliness and accuracy of the conduct of clinical research studies
This individual will be a primary contact for large multi-site research studies. The individual will work directly with the Principal Investigator and Coordinators at each site. The individual will work directly with the Indiana University Genetics Biobank staff. Responsibilities include: develop and maintain training manuals for study sites. Train study sites in correct collection, processing and shipping of biospecimens and data. Update study protocols and consents as necessary to meet changing needs of the study. Provide consent template language to study sites. Prepare study progress reports and present information on a weekly basis to the study sponsor and PIs of study sites. Work directly with study participants to determine subject eligibility and obtain consent. Educate participant and families on disease and study protocol. Maintain current scientific knowledge of biospecimen collection and uses. Educate participants and families on study protocol. Monitor sites for study compliance, regulatory compliance and quality control. Position involves ability to make decision that directly impact the study and subsequently the study funding.
Must meet one of the following qualifications:
Bachelor's degree in science or a health-related field and two years of clinical research experience; OR
Associate's degree in science or a health-related field and three years of clinical research experience.
Demonstrated analytical skills. Ability to simultaneously handle multiple priorities. Possesses strong technical aptitude. Demonstrates a high commitment to quality. Excellent organizational skills.
SOCRA/ARCP clinical research certification.
Working Conditions / Demands
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
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.