Monene Kamm, AS
Monene joined the Deprtment of Radiology in 2003 as a Clinical Research Coordinator and was promoted to Clinical Research Manager in 2018. Her experience includes granted, industry sponsored, and investigator initiated research in multiple imaging modalities and disciplines. In 2015, in addition to her coordinator responsibilities, she was appointed to serve as an Imaging Research Navigator/Liaison for the Radiology Department and Office of Clinical Research to aid researchers within the University of Cincinnati Medical Center when they require radiology/imaging services as part of their research. Currently Monene is assisting Radiology leadership in the design and development of the Core Imaging Lab as part of the department's long term vision. She came to UC Health over 10 years’ experience in microbiological and clinical research experience with a contract research provider.
Monene has broad knowledge of the coordination of clinical trials including protocol and consent development, laws and regulations governing clinical research, IRB submission, patient recruitment and follow-up, and monitoring and audit of clinical research with a focus on imaging research. She enjoys and values mentoring new researchers, which aids her ability to actively serve on the following committees: UC Department of Radiology Research Committee, UC Health Coordinator’s Council, ECOG-ACRIN Imaging Research Associate Executive Committee.
Shantala P. Gangatirkar, MS
Shantala joined the Department of Radiology in October, 2015 as a full time clinical research coordinator after serving for a year as a volunteer coordinator for the UC Department of Neurology. Her experience includes sponsor initiated international oncology and neurology trials. Currently her responsibilities in radiology include study design and coordination, CRF design and data management using REDCap, grant, regulatory, and publication submissions.
Shantala has a Bachelor’s Degree in Ayurvedic (Alternative) Medicine & Surgery from the Maharashtra University of Health Sciences, India. She also has a graduate certificate in clinical research and data management from Pune University, India. In April of 2018, she completed her masters in drug development from UC's James L. Winkle College of Pharmacy.
Vivek J. Khandwala, PhD
Vivek joined the Radiology Department April 2018 as a research associate. He received his bachelor’s degree in Computer Science from Florida Atlantic University followed by MS and PhD in Biomedical Engineering. His doctoral research focused on how upper limb voluntary movements requiring sensory motor integration changed as a function of healthy aging, Parkinson’s disease and subthalamic deep brain stimulation. Through the course of his research he gained significant experience working with human subjects, data (behavioral, 3D motion and EMG) acquisition, validation, processing, verification and analyses. After getting his PhD, he worked as a post-doctoral associate in the department of Neurology at the University of Rochester. His post-doctoral work involved development of an algorithm that used clinically relevant measures extracted from inertial sensors worn by Parkinson’s disease patients for the purpose of aiding the programming of the deep brain stimulator. Beyond his research interests, Vivek likes to volunteer as an emergency medical tech. He will be predominantly working with post data collection pipelines and analyses in the imaging core labs.
Janice Carrozzella, MSN, CNP, RT(R), CCRC
Janice Carrozzella has over 20 years acute stroke trial experience working in multiple capacities from intentional radiology technologist, nurse and certified research professional on both multicenter NIH and industry-sponsored trials to Project Manager for NIH StrokeNet NCC conducted trials. Her experience includes the ability to indepentently manage and execute all aspects of clinical trials from planning, start-up to closeout. She can prepare, submit and maintain multiple levels of research regulatory documentation (e.g., IRB and FDA IND submissions and annual reports, grant renewals, SAE Medwatch reporting, Trial Master File maintenance, CRF, Manual of Procedures, Imaging Charter and Imaging Manual development, etc.) as well as register and maintain Clinicaltrial.gov records.
In addition, Janice has vast experience as the Imaging Data Manager for the UC Neuroimaging Core Lab. She is proficient in overseeing all aspects of study set up services for imaging related components and study site coordination, assurance on anonymization with strict HIPAA compliance, tracking of data transfers, and quality control of imaging data in support of the central imaging readers for multicenter, international NIH and industry-funded stroke trials.
Sadie Caldwell, MS
Sadie Caldwell joined the Department of Radiology in May, 2018 as a Clinical Research Associate after spending ten years in the OB/GYN field. Her initial work as a Medical Assistant/Perinatal Navigator focused on non-invasive prenatal testing (NIPT) in the division of Maternal Fetal Medicine where she also served on the Safety Committee before being promoted to their Research Department in 2016. Sadie's experience includes coordination of activities surrounding study development to ensure compliance with protocol and overall trial objectives as well as facilitating Institutional Review Board submissions and renewals. In addition she prepares and maintains patient recruitment and retention strategies and other duties necessary to maintain the smooth operation of the research enterprise.