Clinical Trial Resource Center


Clinical Trial Resource Center

Research Center Profile:
Meharry Medical College- PCIR

Center Information

Donna C. Skupien
Associate Director
Meharry Medical College- PCIR
1005 Dr. DB Todd Jr. Boulevard
Nashville, TN 37208-5399
USA
615.327.5725
615.327.5835 (fax)
dskupien@mmc.edu
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Contact Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dental and Oral Health
Dermatology
Endocrinology
Gastroenterology
Genetic Disease
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Otolaryngology (Ear, Nose, Throat)
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

Meharry Medical College strives for excellence as a community-focused, quality-driven academic health center noted for preeminence in health disparities research, for significant contributions to the diversity of the nation’s work force in health professions and biomedical research, and culturally sensitive evidence-based healthcare services.

Meharry Medical College is the largest private historically black institution in the United States solely dedicated to educating health care professionals and scientists. Nashville General Hospital at Meharry is a publicly supported, academically affiliated, community-based hospital. We are committed to providing excellent healthcare regardless of age, race, creed, gender, sexual preference or ability to pay. With the alliance of Meharry Medical College and Vanderbilt University, the medical staff and our employees provide comprehensive, compassionate, acute care services to those in need.

Participant and Clinical Interactions Resource

The Participant and Clinical Interactions Resources (PCIR) at Meharry Medical College is a joint project of the Minority Biomedical Research Support (MBRS), the General Clinical Research Centers (GCRC) Program of the Division of Research Resources, National Institutes of Health and Research Centers in Minority Institutions Program (RCMI) of the National Center for Research Resources.

The purpose of the PCIR is to provide the resources necessary to facilitate clinical research in a minority academic setting by expanding existing programs, nurturing new investigators, and encouraging full utilization of its services.

Our mission is to:

  • Promote the advancement of clinical research and improve the health and welfare of disadvantaged and minority populations through participation in clinical studies.
  • Promote and environment that encourages, stimulates, nurtures, and attracts clinical research by providing leadership and support for conducting clinical research.

Clinical Research Experience

Clinical research has been a part of Meharry throughout its history. One of the hallmark research projects was the Meharry Cohort Study, a longitudinal study comparison of mortality and morbidity in medical students at Meharry and Johns Hopkins University which began in the 1950’s. The current period of clinical research development began in 1982 when the college received support from NIH exclusively for clinical research, and with the establishment in 1987 of a Clinical Research Center.

Sponsors and CROs that Meharry Medical College has worked with on clinical research studies include:

Abbott LaboratoriesPfizer, Inc.
Actelion Pharmaceuticals, LtdPPD Development, LLC
Artisan PharmaPRA International Inc.
AmgenQuintiles, Inc.
AstraZeneca LPRoche Laboratories, Inc.
Baxter Healthcare CorporationElan Pharmaceuticals
Bayer Healthcare PharmaceuticalsEli Lilly
Boehringer-IngelheimEndo Pharmaceuticals
Bristol Myers SquibbGenentech, Inc.
Bronchus TechnologiesGilead
Cardiokine Inc.GlaxoSmithKline
Cardium TherapeuticsHoffman-LaRoche Inc.
Celgene CorporationICON Clinical Research
Centocor Ortho Biotech Services, LLCInspire Pharmaceuticals
CovanceJohnson & Johnson PRD
Cystyc / HologicSanofi Pasteur
Keryx BiopharmaceuticalsSanofi Aventis
MDS HarrisSchering-Plough Corporation
MedImmune Inc.Southwest Oncology Group
Novartis Pharmaceutical, Inc.Takeda Pharmaceuticals
Novartis Vaccines and DiagnosticsUnited BioSource Corporation
Osiris TherapeuticsValeant
Parexel International Wyeth Pharmaceuticals
PDL BioPharma Inc.Xanodyne Pharmaceuticals


Clinical Research Services:

  • Clinical research mentorship, guidance with overall process for new investigators and navigation support for experienced investigators
  • Successful clinical protocol development, planning, and implementation support
  • Contract and budget negotiation services, grant process assistance
  • Regulatory management service including assistance with initial IRB protocol submission and all ongoing reporting requirements
  • Qualified research nurse clinical support including study patient recruitment, study eligibility assistance, proper written informed consent process, initial clinical assessment of adverse events and concomitant medications review, and study medication dispensation and post-dose safety monitoring.
  • Proper clinical specimen collection, processing and distribution to relevant core facilities for analysis, storage and shipment.
  • Timely data collection, reporting, and management.
  • Internal speakers from the college are invited to share insight relevant to initiating, sustaining and navigating in the field of clinical research.

Facility Description

The PCIR is conveniently located on the fourth floor of the Old Hospital, readily accessible to both investigators and study patients. Dedicated facility includes administrative research offices, clinical space including 4 fully-equipped exam rooms, and a dedicated centralized and secure with limited access investigational pharmacy. The PCIR Receiving Laboratory / Sample Processing Core is available to investigators for sample collection and processing. Secure, locked storage space is allocated to regulatory and data storage, all study-related materials, and lab equipment and supplies. Ample space is available to provide to study subjects on extended visits, including, lunch room, TV/DVD area, and a bed to rest.

Investigator Experience

Medical Director, PCIR

John J. Murray, M.D., Ph.D., is Associate Vice President for Research and Professor of Internal Medicine and Biomedical Sciences at Meharry Medical College, Adjunct Professor of Medicine and Pharmacology at Vanderbilt Medical School, and attending physician at Nashville General Hospital and Vanderbilt Hospital. Dr. Murray’s primary role at Meharry is to oversee the clinical research enterprise that includes supervising clinical trials, educating clinical investigators, and ensuring compliance with regulatory and ethical aspects of human research.

After graduation from Harvard College, he received doctoral degrees in Medicine and Pharmacology from Vanderbilt and was an Exchange Fellow of the National Institute of Health and the Soviet Academy of Sciences. After completing a residency and chief residency in internal medicine and a research fellowship in clinical pharmacology at Vanderbilt, he was a postdoctoral fellow in rheumatology/immunology and allergy/immunology/pulmonary medicine at Duke School of Medicine remaining on the faculty until his return to Vanderbilt holding the Elizabeth and John Murray Chair of Medicine prior to his recent roles at Meharry. In addition to being an associate editor for Lipids, Dr. Murray serves as a reviewer for such journals as the New England Journal of Medicine and the Journal of Immunology. Dr. Murray is the author of nearly 300 articles and abstracts, serves as an invited lecturer at national and international meetings, and is included in Best Doctors in America and Who’s Who in Medicine and Healthcare. In addition to his active clinical practice, he lectures, oversees research supported by the NIH, foundations and private organizations, and has directed numerous clinical trials of novel therapies in a variety of disease.

Staff Expertise

Associate Director, PCIR

Donna Skupien RN, BSN, CCRP is Associate Director of the clinical research operations of the Participant and Clinical Interactions Resource (PCIR) at Meharry Medical College. The overall objective of the PCIR is to retain the strengths of Meharry’s RCRII-supported Clinical Research Center (CRC) while evaluating and extending a recent reorganization that improves the support of translational, community-based, and industry-sponsored studies. Ms. Skupien has over 24 years of clinical research experience and 15 years of successful leadership and management roles within commercial and academic research facilities and models, with the expertise to manage the operations, strategic planning and the future program development of the PCIR. In 1996, Ms. Skupien founded QUEST Research Institute (Bingham Farms, MI) a dedicated multispecialty clinical research site. She identified, trained, and managed clinical research professionals ranging from entry-level research assistants to clinical investigators. Prior experience of providing consulting expertise in clinical research program development to academic medical centers, community hospitals, and physician practice groups will be fundamental in the approach to developing the critical infrastructure needed to support the projected growth of the PCIR.

PCIR Team members

The PCIR clinical research team is lead by a Medical Director who provides clinical and academic mentorship and expertise to participating investigators. An Associate Director who supports the Medical Director in promoting and supporting the mission of the PCIR and managing the day to day operations and research activities of the site. Research nurses and study coordinators are experienced and certified in the conduct of research in human participants. All team members receive CITI training, including FDA Good Clinical Practice Guidelines and PCIR Standard Operating Procedure training. All available team members attend all study planning and start-up meetings to become familiar with the specifications and clinical logistics of the study. Team meets weekly to review subject recruitment, conduct, patient safety, and future planning for successful study management. All PCIR team members are current members of SoCRA (Society of Clinical Research Associates) and all qualified staff are encouraged to pursue CCRP certification.

Patient Demographics

Consistent with Meharry’s mission and commitment to serve the community, educate and train African American and ethnic minority dentists and physicians is its commitment to developing the competitiveness of its faculty to conduct patient-oriented research with special emphasis on improving oral health conditions and medical conditions that disproportionately affect society’s most disadvantaged and underserved minorities.

Focused subject recruitment campaigns are implemented early on in the study initiation process. Once recruitment materials are IRB approved, they are used to educate and in-service staff about study unique patient populations and considerations. Internal physician referrals from our clinics are supplemented with additional methods including internet outlets including ResearchMatch, CenterWatch, and the Meharry Medical College ResearchPoint intranet. Broadcast e-mails communicating our current research opportunities are sent routinely to the entire Meharry community, including faculty, staff and students. Print campaigns are launched for recruitment posters, flyers, and print advertising. The hands-on approach of the PCIR team to reach the Nashville community through local churches, support groups, and health fairs is fundamental to our grassroots approach to patient education and successful subject recruitment.

Other Information

The Meharry Medical College Institutional Review Board is fully accredited and meets twice monthly. While our IRB is prided to be very efficient and industry-sponsored research friendly, we are able to utilize a central IRB, if deemed appropriate.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.

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