Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures.
Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol; performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals; collects patient consent and authorization for treatment intervention documents and performs those interventions as needed.
Conducts routine experiments and/or coordinates research study procedures in accordance with SOPs; receives, collects, and records study data in database; communicates and keeps researchers and/or PI up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.
Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.
Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.
Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments.
Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription).
Stays up-to-date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
EDUCATION / WORK EXPERIENCE
Bachelor's degree in science or a health-related field OR
Associate's degree in an allied health profession and 1 year of patient-related or research experience OR
Bachelor's degree in any field OR 3 years of college-level science and 2 years of patient-related or research experience OR
High school diploma or GED and 5 years of patient-related or research experience that includes 2 years of experience with clinical studies
Combinations of related education and experience may be considered.
Proficient communication skills
Maintains a high degree of professionalism
Demonstrated time management and priority setting skills
Demonstrates a high commitment to quality
Possesses flexibility to work in a fast paced, dynamic environment
Highly thorough and dependable
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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Beginning with the fall 2021 semester, all Indiana University students, faculty, and staff will be required to be fully vaccinated for COVID-19 as a condition of enrollment / employment.To learn more about this requirement, view ourCOVID-19 vaccine information page .
Equal Employment Opportunity
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.