Provide overall direction for compliance of all clinical and preclinical research conducted by Radiology and Imaging Sciences. Develop a quality and compliance plan for all internal Radiology and Imaging Sciences research studies. This role will also provide compliance direction to the Radiology clinical research team for auditing, monitoring and validation of data on all Radiology and Imaging Sciences Investigator Initiated Trials and Industry Trials. Utilizing a risk-based stratification, oversee and participate in ongoing quality assurance through monitoring and process improvements. Consult with investigators who have been notified that they will undergo an external audit to correct any deficiencies. Review external audit and monitoring reports and work with researchers and regulatory agencies regarding audit citations, monitor findings and/or suspected non-compliance. Advise administration of any auditing trends or issues and develop quality improvement plans as needed.
Bachelor's degree and four years of experience.
Clinical research certification (ACRP or SoCRA) or Research Compliance (CIP or CCEP) or Quality Improvement Certification (CQIA).
Combinations of education and related experience may be considered.
Excellent communication skills and ability to effectively exchange information, including the ability to train using a variety of methods and communicate compliance requirements to the radiology clinical research teams. Knowledge of procedures and regulations specific to the conduct of clinical trials. Knowledge of Good Clinical Practice Guidelines. Excellent organizational,analytical, prioritization and supervision skills, including the ability to multitask. Demonstrate diplomacy, motivation, tact and a professional demeanor. Demonstrated expertise and experience in auditing and quality improvement.
Master's degree. Monitoring experience.
Working Conditions / Demands
Ability to perform the essential functions of the position with or without accomodation.
Goodman Hall, Neuroscience Center
Salary Plan: PAE
Salary Grade: 3AD
Job Function: Legal, Safety, & Protection
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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.