The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is funded by the National Institute on Aging (NIA) to address several major gaps in Alzheimer's disease and related dementia research. LEADS is an observational study that will enroll and follow 500 cognitively impaired participants and 100 cognitively normal participants ages 40-64 years at approximately 15 sites in the United States. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed. The primary goal of LEADS is to develop sensitive clinical and biomarker measures for future clinical and research use.
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
Participates in study budget negotiations and reconciles study budget accounts.
Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)
Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
Stays up to date with knowledge of regulatory affairs and/or issues.
EDUCATION / WORK EXPERIENCE
Bachelor's degree in science or a health-related field and 2 years of clinical research experience OR
Associate's degree in science or a health-related field and 3 years of clinical research experience
Combinations of related education and experience may be considered.
LICENSES AND CERTIFICATES
SOCRA/ARCP Clinical Research Certification Upon Hire
Demonstrated analytical skills
Ability to simultaneously handle multiple priorities
Possesses strong technical aptitude
Demonstrates a high commitment to quality
Excellent organizational skills
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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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
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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.