Clinical Trials Compliance & ClinicalTrials.Gov Team

Contact Information

Phone: 404-778-3840

Email: jprozon@emory.edu

Biography

Jennifer Prozonic is the Associate Executive Director for the Clinical Trials Transparency & Oversight team in Emory University's Office for Clinical Research (OCR). Jennifer has worked at Emory since 2009 and joined OCR in 2010. Her current work focuses on ClinicalTrials.gov compliance with federal regulations and NIH policy, as well as facilitating research and billing compliance with investigator-initiated, federal, and industry-sponsored clinical research on behalf of Emory. She has over twenty years of experience in both clinical and basic science research, which also includes regulatory and budgetary expertise.

Jennifer has a Master of Public Health in Informatics from the Medical College of Georgia. She is also certified in Healthcare Research Compliance (CHRC) with the Health Care Compliance Association (HCCA) and is a certified Clinical Research Coordinator (CCRC) with the Association of Clinical Research Professionals (ACRP).

Contact Information

Phone: 404-778-1538

Email: ianzola@emory.edu

Biography

Isabel joined the Office for Clinical Research in May 2019, with more than seven years of experience in clinical research at Emory University. In her current position as a Research Service Consultant in Clinical Trials Compliance, she assists study teams throughout Emory with ClinicalTrials.gov concerns and clinical trial questions. She registers studies into ClinicalTrials.gov, ensures that records remain in compliance with federal registration laws, and assists study teams with entering study results.

Isabel had been a Clinical Research Coordinator and a Postdoctoral Research Fellow at the Emory University Division of Endocrinology, Metabolism and Lipids, working in long-term multi-site clinical trials of inpatient glycemic control for type II diabetes. She has vast experience with clinical research management and procedures. Isabel has a Doctor of Medicine degree from the Universidad Central de Venezuela.

Contact Information

Phone: 404-610-4503

Email: scardon@emory.edu

Biography

Saumeth Cardona has joined the Office for Clinical Research in August 2021 with more than 10 years of experience clinical research at Emory University. In her current position as a Research Service Consultant in Clinical Trials Compliance, she assists study teams throughout Emory with ClinicalTrials.gov concerns and clinical trial questions. She registers studies into ClinicalTrials.gov, ensures that records remain in compliance with federal registration laws, and assists study teams with entering study results. She has been actively involved in clinical trials at the Emory University with the Endocrinology division, focused on diabetes and metabolism, specifically related to an individuals’ risk for development of stress hyperglycemia, finding best strategies to treat hospitalized patients with diabetes, and on finding predictors associated with outcomes in patients with hyperglycemia in the hospital and ambulatory setting. Saumeth was actively involved in several inpatient diabetes trials, evaluating the efficacy of newer ultralong acting insulins in the hospital setting and assessing the accuracy of continuous glucose monitors in a hospitalized population. She has vast experience with clinical research management and procedures. She was the recipient of the Ruth L. Kirschstein National Research Service Award during her post-doctoral research fellowship. She earned her medical degree from Zaparozhye State Medical University in Ukraine and has an MPH from the Emory Rollins School of Public Health in 2016.

Contact Information

Phone:404-712-3239

Email: anna.lafae@emory.edu

Biography

Anna LaFae is a Senior Clinical Trials Compliance Manager for the Clinical Trials Transparency & Oversight team in Emory University's Office for Clinical Research (OCR). She has worked on research projects at Emory University since 2005 when she was a student and began full-time employment upon graduation. She has been a Research Coordinator in the Department of Epidemiology working on a long-term cohort study and worked on a wide variety of projects as a Clinical Research Coordinator in the adult and pediatric Infectious Disease divisions. Her background education and work has focused on reproductive health, endocrine disruption, multidrug resistant organisms, sexually transmitted infections, HIV, and hepatitis C. As well as the day-to-day operations of research studies, she has experience with regulatory aspects of federal and industry-sponsored studies. Anna joined the Office for Clinical Research in January of 2016 and assists study teams throughout Emory with ClinicalTrials.gov concerns. She registers studies into ClinicalTrials.gov, ensures that records remain in compliance with federal registration regulations, and assists study teams with entering study results. She loves to fit complex study designs into the required format of ClinicalTrials.gov.

Anna earned a Bachelor of Science in Health Sciences from Boise State University and a Master of Public Health in Epidemiology from Emory University. Anna is certified in Healthcare Research Compliance (CHRC) with the Health Care Compliance Association (HCCA).

Contact Information

Phone: 404-712-5953

Email: rekha.g.menon@emory.edu

Biography

Rekha joined the Office for Clinical Research in 2010 and has over 10 years of experience in clinical research. She has a hands-on working knowledge of research and has been actively involved in clinical trials. In her current position as a Research Consultant in Clinical Trials Compliance, Rekha is responsible for the thorough review of complex study protocols and the optimal application of federal guidance documents and Emory University institutional policies. She is responsible for the review of complex study protocols and Informed Consent Documents (ICDs) to identify all Emory Healthcare (EHC) and/or Grady billable items or services that may require a of Prospective Reimbursement Analysis (PRA) for research billing compliance.

Rekha is responsible for the review of Clinical Trial and Applicable Clinical Trial determination criteria to ensure compliance with FDA, ICMJE, NIH and Emory University policies and guidelines. She also provides policy and process interpretation to academic departments/ schools and divisions related to ClinicalTrials.gov. Rekha has earned her M.B.B.S. from the University of Bombay and has a CHRC certification from the Healthcare Compliance Association.