Indiana University School of Medicine is a national leader in medical research and education. With more than 60 academic departments and specialty divisions across nine campuses statewide and strong clinical partnerships with Indiana's most advanced hospitals and physician networks, the school is continuously advancing its mission to prepare healers and transform health in Indiana and throughout the world. The Indiana CTSI is dedicated to leveraging and strengthening the state's life sciences community to achieve better health for people in Indiana. The Indiana CTSI represents a collaborative partnership among the state's preeminent research enterprises, Indiana University, Purdue University and the University of Notre Dame, that spans all 92 counties in Indiana. Since its founding in 2008, the Indiana CTSI has secured more than $88 million in National Institutes of Health (NIH) funding to improve health in Indiana through research. The institute has built research infrastructure in Indiana, attracted top scientific talent to the state and worked to identify and improve our community's greatest health challenges.
We are looking for an innovative trailblazer and trainer to help shepherd research studies through the IRB process and ensure consistent and complete submissions to improve efficient review of processes. The ideal candidate for the Quality Assurance/Quality Control (QA/QC) Project Manager position will be enjoy creating something new while also paying attention to detail and quality. This position will also navigate the National Center for Advancing Translational Sciences (NCATS) Human Subjects Research (HSR) Prior Approval (PA) process for early career investigators and pilot projects on behalf of the Indiana CTSI. The QA/QC Project Manager will manage the overall HSR PA process in the Human Subjects System and will be the Indiana CTSI point of contact for these submissions. This position will also train early career investigators on regulatory review processes and compliant conduct of human subjects research. Once studies are approved, the QA/QC Project Manager will monitor studies to ensure data quality and compliance. This position is grant funded.
Bachelor's degree and four years of experience in the areas of IRB submissions, research compliance, grant submissions, clinical research, and/or quality assurance/quality control.
Strong interpersonal skills. Ability to take responsibility and resolve problems. Good decision making capabilities and ability to articulate complex situations and prioritize. High level of accuracy and attention to detail. Ability to communicate effectively with multiple stakeholders. Possess understanding of regulatory requirements (45 CFR 46, GCP). Strong understanding of any applicable regulations (e.g., Good Clinical Practice/ICH guidelines, FDA CFR, clinical research ethics, HIPAA and patient privacy laws). Ability to develop and deliver training.
Master's degree or professional graduate degree with five years of experience in the areas of IRB submissions, research compliance, grant submissions, clinical research, and/or quality assurance/quality control. Certification in related field (e.g., CIP, CCRA, CCRP, CCRC). Ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. Experience with Clinical Trial Management Systems (CTMS), IRB and/or grant management systems, Microsoft Word, Excel, Powerpoint.
Working Conditions / Demands
Must be able to perform essential job functions with or without an accommodation.
Equipment utilized: Computers, phone, fax machine, copy machine, printer, scanner, Microsoft Office programs, and Clinical Trials Management Systems (CTMS).
Salary Plan: PAE
Salary Grade: 3AD
Job Function: Compliance & Regulatory Affair
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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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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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.