Center of Excellence for Clinical and Translational Research
The purpose of the CoE CTR is to provide the resources necessary to facilitate translational, community-based, and multi-center clinical research projects at Meharry.
We are expanding existing programs, nurturing new investigators, and encouraging full use of our services. We can conduct your study and execute your data collection. We are here to cultivate your scientific skill set and ensure you are on the road to independent research.
- We review your studies and advise you on their feasibility.
- We help you design and construct studies.
- We execute your studies, drawing and processing biological samples—and collecting the necessary regulatory documents.
- We provide you a CITI-trained nursing staff who meet regularly to discuss your protocol.
- We offer monthly training on developments in the field of translational research.
Participate in a Trial
Advancing our understanding of how the human body works when it is healthy and developing new, more effective vaccines and therapies requires clinical research on human beings. Unfortunately, many studies end prematurely simply because there are not enough participants who qualify, and the scientists conducting studies are unable to locate new participants.
If you would like to be contacted when we have a study relevant to your age, gender, family history, disease history, or other interests, please contact us at (615) 327-6820. The CoE CTR can also help you sign up at ResearchMatch.org, a nationwide registry that matches volunteers with scientific studies. Member institutions and their scientists can now look to the registry for a ready source of potential volunteers.
If you have questions about what it means to be a research participant, please contact the Regulatory Affairs Unit at 615.327.5654 or irb@mmc.edu.
COVID-19 Vaccine Trials
We are currently recruiting for COVID-19 Vaccine Trials. Please complete this form or call 615.327.6820 for information about volunteering.
Center of Excellence for Clinical and Translational Research Team
Rajbir Singh, MBBS
Associate Professor, Department of Internal Medicine
Co- Director, Center for Women’s Health Research
Executive Director, Center of Excellence for Clinical and Translational Research
Executive Director, Precision Medicine and Health Trials Design
Director, Regulatory Compliance Office, NIH AIM-AHEAD Consortium
Co-Director, Center for Women’s Health Research
Co-Investigator, NIH AIM-AHEAD Leadership Core Southeast Hub
Chair, Institutional Review Board (IRB), Meharry Medical College
rsingh@mmc.edu
Jennifer L. Bethune, LPN, CHC
Clinical Research Coordinator-I
Center of Excellence for Clinical and Translational Research
Hannah Connelly
Clinical Research Coordinator I – Phlebotomist
Center of Excellence for Clinical and Translational Research
hannah.connelly@mmc.edu
Abraham Garcia Ortega, M.D.
Clinical Research Coordinator II
Center of Excellence for Clinical and Translational Research
agarcia@mmc.edu
Rebecca Hardin, MSN, RN, PMH-BC
Clinical Research Coordinator-II
Center of Excellence for Clinical and Translational Research
rebecca.hardin@mmc.edu
Sabrina Knight
Clinical Research Coordinator I
Center of Excellence for Clinical and Translational Research
sabrina.knight@mmc.edu
Anaite Montes Bu
Clinical Research Data Analyst
Clinical Research Coordinator
Center of Excellence for Clinical and Translational Research
amontesbu@mmc.edu
John Oleis D.Ph.
Clinical Research Pharmacist
Center of Excellence for Clinical and Translational Research
john.oleis@mmc.edu
Henry Ong, Ph.D.
Program Manager Together for Change
Center of Excellence for Clinical and Translational Research
henry.ong@mmc.edu
DeAnthony Reed, B.A.,M.S.
Clinical Research Coordinator I
Center of Excellence for Clinical and Translational Research
deanthony.reed@mmc.edu
Sheena Simon, DNP, APRN, NP-C
Clinical Research Coordinator-II
Nurse Practitione
ssimon@mmc.edu
Glory Stanton
PCIR CRC I
gstanton@mmc.edu
Zudi-Mwak Takizala, M.D., MBA, MPH
Director of Clinical Operations and Ryan White Program
Department of Internal Medicine
ztakizala@mmc.edu
Cassandra Wheeler, DNP, APRN, FNP-BC
Clinical Research Nurse Practitioner
Center of Excellence for Clinical and Translational Research
cassandra.wheeler@mmc.edu
Sonja White, PharmD
Research Coordinator II/Pharmacist
Office for Research & Innovation
Center of Excellence for Clinical and Translational Research
sowhite@mmc.edu
Major Projects
EMERGE (Electronic Medical Records and Genomics) Trial: Results provided to 500 African American participants enrolled for genomic testing
Nashville Early Diagnosis Lung Cancer Project: High risk participant screening for lung cancer for a period of 5 years
PREVENTABLE Trial: Role of STATINS in elderly (>75 years of age) and dementia and cardiovascular disease-free survival
COVID-19 Vaccine Trials: Meharry’s CTRC approved as a site to conduct COVID-19 vaccines: Received $1.5M from Novavax
Bayer and AMGEN trials: Completed 2020. Closed to accrual.
IGNITE (Implementing Genomics in Clinical Practice) Trials: GUARDD-US (Genomic testing to Understand and Address Renal Disease Disparity in US) enrolling African- American participants with hypertension and chronic kidney disease for APOL-1 gene testing.
- ADOPT Precision Medicine
- GUARDD Genomics
- SCARAB: Genomics biomarkers for Sepsis
- Harbinger: Genomics biomarkers for Cancer Screening
- Roche: Genomics biomarkers for Cancer Screening
- PCORnet database: Non-therapeutic
- American Thoracic Society – Vaccination
- American Pulmonology Society – MUSIC
Clinical Trials
Clinical trials are beyond the scope of most researchers’ budgets and staff skill sets. The CTRC will do the heavy lifting for you, helping you design the study, working with the IRB, locating study subjects, providing nursing staff who know your protocol, and more. Contact Rajbir Singh for more information.
Nursing
The CTRC nursing staff provide nursing care to adult research patients and study participants. Research participants are seen on an out-patient basis. When a study requires the use of scatter beds, our staff coordinate with Metropolitan Nashville General Hospital at Meharry. We have an all-registered nursing staff, who are trained in research nursing, good clinical practice, and the IRB’s required CITI course. Additionally the nursing staff are required to attend meetings for clinical protocol training. The nurses provide direct and indirect patient care. They spend additional time completing management support activities. Prep-time includes preparation of the protocol, consent forms, and HIPAA addenda for submission to the IRB. Regulatory documents are also part of the prep-time. The nurse coordinator for each study educates the staff about the study and ensures that the protocol is followed. The staff cross-train to support each other when a coordinator is on leave. We have 24-hour access for patient/nurse contact to address adverse events. Nurses provide support in community health outreach and assistance with Spanish.
Sample Processing
We draw and process blood and urine for distribution to relevant core facilities for analysis. Our core lab is also available to clinical investigators for sample processing and has two bench-top centrifuges, a microhematocrit, and two blood-drawing chairs. An additional laboratory is available to process 24-hour urine samples for shipping. There are also two refrigerators and an ultra-low freezer available for storing biological samples.
Equipment
Beckman Coulter Allegra X-22, X-22R, Avanti J-15R and a VWR Mega Star 1.6 Centrifuges
Enterprise Refrigerator
Ultra-low Freeze (VWR Signature Model 5606)
American Scientific Products Biofuge A Microhematocrit
Cell-Dyn 3500 Hemoglobin Analyzer (Pediatric Research Laboratory
Dupont Super-Speed Centrifuge (Pediatric Research Laboratory)
Waters HPLC (Pediatric Research Library)
Education and Training
Education/training is provided for all interested parties including clinical faculty and staff. The format is a monthly, hour-long seminar running from August to May. Speakers from Meharry are invited to share insights relevant to initiating, sustaining, and navigating the field of clinical research.
Research Pharmacy
The Research Pharmacy is an integral part of the research process at Meharry Medical College, which supports all Meharry investigators in the conduct of industry and federally funded drug studies, investigator-initiated studies, and compassionate and expanded access drug use. Our mission is to provide research pharmacy services to Meharry and Nashville General Hospital patients, investigators, and sponsors, and in the process ensure that research drugs are handled safely, accurately, and effectively while following all FDA guidelines and Sponsor requirements. We offer the following services: Protocol Management/Drug Accountability, Investigational Drug Storage under the protocol specific temperature parameters, sterile medication compounding, record retention, and appropriate disposition per protocol of used, unused, expired, or hazardous investigational medications.
New Trials
- The ARDS, Pneumonia, and Sepsis (APS) Consortium -A Prospective Observational Study to Evaluate Phenotypes, Master and Part B
- PROACTION: PROspective ACcrual to Investigate reprOductive cancers in women (Genomic biomarkers in endometrial Cancer)
- AsseSing a Biomarker PlatfOrm for STratifying IndeterminTe Pulmonary Nodules-The SPOT IT Platform Trial
- T4C GREAT Study: Recruitment will be starting soon to recruit 20,000 participants
- Enhancing the understanding of loss-of-function gene variants in chronic diseases with known health problems (e.g., cancer, diabetes, CKD, psychiatric disorders). 2500 Participants