Carolyn Smith
Fayetteville
Summary
Clinical Research Site Manager and Senior Clinical Research Coordinator with 17+ years of progressive experience spanning academic research, laboratory management, and Phase II-IV clinical trial operations. Experienced in regulatory compliance, study start-up, financial oversight, team leadership, and audit readiness. Proven success managing 20+ concurrent trials while maintaining GCP and FDA compliance. Strong background in laboratory sciences with multiple peer-reviewed publications.
Overview
17
17
years of professional experience
Work History
Clinical Research Site Manager
Cross Creek Medical Clinic, PA
Fayetteville
10.2025 - Current
- Successful Management of over 20 Phase II-IV Clinical Trials
- Ensured compliance of all studies with the protocol, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulations.
- Coordinated startup activities to ensure timely study initiation and compliance with protocols.
- Ensured smooth study activation by coordinating SIV meetings, preparing training logs, and overseeing Delegation of Authority logs.
- IRB submissions including initial study applications, protocol modifications and continuing review and study closeout applications
- Drafted and adapted Informed Consent Forms (ICF), Assents, and regulatory documents for IRB submissions
- Scheduled and conducted Monitor Visits, maintaining regulatory files systematically for easy access.
- Coordinated responses to audits and inspections from sponsors, CROs, and FDA to maintain regulatory compliance and uphold study integrity.
- Facilitated budget and contract negotiations with sponsors/CROs to secure favorable terms for study execution.
- Monitor study financial performance: revenue and internal costs
- Demonstrated proficiency in using clinical trial management systems (CTMs), electronic data capture (EDCs), and interactive response technology (IRT) systems.
- Lead CAPA (Corrective and Preventive Actions) when issues are identified
- Recruit, hire, and train new coordinators
- Supervise coordinators, research nurses, regulatory staff, and support staff
- Assign studies and workloads across the team
- Acted as Senior CRC and Regulatory Coordinator for various studies.
Clinical Research Coordinator
The Geneva Foundation
Fort Liberty
07.2021 - 10.2025
- Led participant recruitment and served as primary contact throughout study.
- IRB submissions including initial study applications, protocol modifications and continuing review and study closeout applications
- Coordinated preparation of regulatory applications and administration of study procedures at Ft Bragg and NMCCL.
- Maintain and update regulatory documents such as protocols, approvals, amendments, and modifications
- Managed data collection and ensured integrity for analysis systems.
- Entered participant data accurately into Fitbir and RedCap systems.
- Review study consent documents with participants and answer study questions
- Conduct follow-up appointments
- Conduct clinical testing for the CAMP study
- Prepare and submit annual project reports
- Provided training to new staff members.
- Engaged in Eirb training meetings and conferences to enhance knowledge.
- Adhere to Good Clinical Practices
- Follow, maintain, and update the standard operating procedure.
Customer Service Representative
Walgreens
Columbus
04.2021 - 08.2021
- Provided customer service support to address patient inquiries and enhance experience
- Answer questions in regards to vaccination and Covid testing
- Assisted with Covid vaccine registration to facilitate community access to vaccination
- Book and reschedule appointments
- Entered patient information into electronic health records to maintain accurate and up-to-date documentation.
Research Assistant II
LSU Health Shreveport
Shreveport
05.2020 - 10.2020
- COVID-19 diagnostic testing site research assistant
- Processed clinical samples to support accurate diagnostic testing.
- Perform Real-time PCR using SARS-COVID2 controls
- Perform RNA extractions using Mag-Bind Viral RNA Xpress Kit and the Hamilton Micro Lab Star or Eppendorf extraction system
- Troubleshoot the Hamilton Micro Lab Star or Eppendorf extraction systems
- Linked PCR results through REDCAP
- Trained new laboratory personnel on Hamilton Micro Lab Star and Eppendorf systems to ensure proficiency in testing procedures.
Research Assistant II
LSU Health Shreveport
Shreveport
01.2018 - 10.2020
- Prepared Lab reports
- Experiment planning and troubleshooting
- Cataloged and updated the sample database.
- Continuously updated the electronic chemical inventory
- Prepared sequencing samples
- Perform Real-time PCR
- Endpoint Genotyping Assay
- Optimized and performed fluorescent immunohistochemistry protocols
- Utilized Zeiss AxioObserver & Apotome microscope to quantify IHC and generate images
- Perform DNA and RNA extractions using various kits and Magna Pure extraction system
- Handled and tested clinical samples for a number of viruses
- Used Peoplesoft to create, review and update requisitions
- Completed monthly procurement card reconsolidation.
- Managed lab supply inventory, ordered supplies, and restocked as needed.
- Diagnosed and resolved equipment malfunctions in the lab.
- Trained new lab members and medical interns on protocols and procedures.
- Performed maintenance on the Magna Pure extraction system.
- Organized the proper storage and disposal of reagents and biohazard materials
- Prepared buffers, dilutions, and reagent solutions.
- Entered data and managed databases effectively.
Research Assistant II and Lab Manager
UT Southwestern Medical Center
Dallas
08.2015 - 10.2017
- Responsible for setting up flow cytometers in the morning
- Sorted and analyzed data in various flow cytometers (BD AriasII, BD Fusion, BD Canto Analyzers, and BD LSR Fortessa) to support research objectives
- Provide customer support
- Trained new users on flow cytometry protocols and equipment operation to enhance lab proficiency
- Provide customer support
- Responsible for running maintenance and performance check (CST and Accudrop)
- Maintain antibodies, buffers and supplies in stock
- Troubleshoot flow cytometers
- Switched out filters and sample lines to ensure optimal instrument performance and reliability
- Autoclave and dispose of biohazardous material.
Laboratory Assistant
Sanford Burnham Medical Research Institute
Orlando
03.2014 - 07.2015
- Studying the molecular causes and histomorphology of arterial calcification
• Sectioned with a cryostat tissue for IHC protocols
• Performed immunohistochemistry staining
• Optimized and performed fluorescent immunohistochemistry protocols
• Utilized Nikon A1R VAAS Inverted confocal microscope to quantify IHC and generate images
• Assisted in collection of data and performed statistical analyses
• Performed stereological cell counts using an Image J
• Organized the proper storage and disposal of reagents and biohazard materials
• Prepared buffers, dilutions, and reagent solutions.
Research Assistant
University of North Carolina Wilmington
Wilmington
03.2013 - 03.2014
- Assist in collection of data and perform statistical analyses
- Handle animals in preparation for treatments and behavioral tests
- Perform DNA and RNA purifications
- Perform Real-time PCR
- Perform ELISA's Assays
- Responsible for data entry
- Mouse line maintenance
- Responsible for training new laboratory members
- Organized the proper storage and disposal of reagents and biohazard materials
- Continuously updated the electronic chemical inventory.
Research Assistant
Ichan School of Medicine at Mount Sinai
New York
05.2012 - 02.2013
- Studying the molecular and cellular mechanisms of neurological disorders such as Parkinson's, Huntington's and Alzheimer's disease
- Perform transcardial perfusion on mice
- Executed DNA and RNA purifications to support molecular analysis of neurological disorders
- Perform Real-time PCR
- Mouse line maintenance
- Monitored animal genetic crosses to ensure proper lineage and genetic integrity
- Conducted animal genotyping (tail clipping) to confirm genetic profiles for research purposes
Research Assistant
Hunter College of the City University of New York
New York
01.2012 - 05.2012
- Studying the role of prostaglandin J2 (PGJ2) in Parkinson's Disease
- Prepare buffers, dilutions, and reagent solutions
- Optimize and perform fluorescent immunohistochemistry protocols
- Prepare tissue samples for western blot
- Optimize and perform western blot analysis
- Perform transcardial perfusion on mice
- Perform stereological cell counts using an AxioVision microscope
- Assist in collection of data and perform statistical analyses
- Handle animals in preparation for treatments and behavioral tests
- Quantify and analyze cylinder test (behavioral assay)
- Quantify and analyze pole test (behavioral assay)
- Prepare buffers, dilutions, and reagent solutions
- Handle animals in preparation for treatments and behavioral tests
- Keep track of animal genetic crosses
- Animal Genotyping (Tail clipping)
- Perform DNA and RNA purifications
- Perform Real-time PCR
- Perform ELISA's Assays
- Responsible for data entry
- Mouse line maintenance
Research Assistant
Hunter College of the City University of New York
New York
03.2009 - 01.2012
- Studied the role of striatal neuropeptides in methamphetamine-induced toxicity
- Organized the proper storage and disposal of reagents and biohazard materials
- Continuously updated the electronic chemical inventory
- Prepared buffers, dilutions, and reagent solutions
- Sectioned with a cryostat tissue for IHC protocols
- Optimized and performed fluorescent immunohistochemistry protocols
- Prepared tissue samples for western blot
- Performed western blot analysis
- Prepared and treated mice with intraperitoneal (IP) injections
- Performed transcardial perfusion in ICR mice
- Prepared animals and assisted in stereotaxic surgery on mice
- Utilized Leica scanning confocal microscope to quantify IHC and generate images
- Assisted in collection of data and performed statistical analyses
- Responsible for training new laboratory members.
Summer Intern
Columbia University
New York
05.2010 - 08.2010
- Conducted a forward genetic screen for genes required for neuronal morphogenesis identified autophagy-related 1 (Atg1)
- Conducted a forward genetic screen in Drosophila melanogaster to identify a complementation group consisting of four alleles that all showed similar dendritic abnormalities
- Performed mapping experiments to identify the gene mutated in the fly lines
- Performed genetic crosses between the mutant lines and several deficiency strains containing large deletions on the third chromosome
- Localized the mutation's cytological interval
- Ran immunofluorescence protocols
- Worked with Leica Confocal microscopes
- Performed statistical analysis of the data collected.
Education
MASTERS OF PUBLIC HEALTH ADMINISTRATION -
Louisiana State University Shreveport
Shreveport, LA10-2020
BACHELOR OF ARTS - PSYCHOLOGY
Hunter College of the City University of New York
05-2012
EMERGENCY MEDICAL TECHNICIAN -
Bergen County EMS Training School
05-2008
Skills
- IRB Submissions
- Phase II-IV Clinical Trial Management
- GCP & Regulatory Compliance
- Participant Recruitment
- SOP Development and Implementation
- Budget reconciliation
- Assess Study Feasibility
- Quality Assurance
- Database Management (EDC)
- Project Management
- Internal Audit Management
- Lab Specimens and Collections
- Data Analysis
- Workflow optimization
- Site management
Publications
- The Role of the Neuropeptide Somatostatin on Methamphetamine and Glutamate-Induced Neurotoxicity in the Striatum of Mice., Lauriaselle Afanador, Ina Mexhitaj, Carolyn Diaz, Dalila Ordonez, Lisa Baker, and Jesus A. Angulo., Brain Research, May 2013
- Diet-induced obesity attenuates cytokine production following an immune challenge., Katherine M Baumgarner, MS; Sharay Setti; Carolyn Diaz; Alyssa Littlefield; Amanda Jones; Rachel Ann Kohman, PhD., Behavioral Brain Research, July 2014
- Vascular Smooth Muscle LRP6 Limits Arteriosclerotic Calcification in Diabetic LDLR-/- Mice By Restraining Noncanonical Wnt Signals., Su-Li Cheng, Bindu Ramachandran, Abraham Behrmann, Jian-Su Shao, Megan Mead, Carolyn Smith, Karen Krchma, Yoanna Bello, Attila Kovacs, Kapil Kapoor, Larry Brill, Ranjan Perera, Bart O. Williams and Dwight Towler., Circulation Research, July 2015
- Epidemiological and molecular characterization of a novel adenovirus of squirrel monkeys after fatal infection during immunosuppression., Donna L. Rogers, Julio C. Ruiz, Wallace B. Baze, Gloria B. McClure, Carolyn Smith, Ricky Urbanowski, Theresa Boston, Joe H. Simmons, Lawrence Williams, Christian R. Abee and John A. Vanchiere., Microbial Genomics, March 2020
References
References available upon request
Abstracts And Conferences
- Somatostatin attenuates methamphetamine-induced dopamine terminal damage in the murine striatum., Diaz, C., Afanador, L, and Angulo, J.A., Annual Biomedical Research Convention, Saint Louis, MO, 2011
- Modulation of methamphetamine-induced neuronal nitric oxide formation by somatostatin agonist., Diaz, C., Afanador, L, and Angulo, J.A., 20th Annual Neuron Convention, New York, NY, 2011
- Forward genetic screen for genes required for neuronal morphogenesis identifies autophagy-related 1 (Atg1)., Diaz, C., and Grueber, W., CUNY Science Fair, New York, NY, 2011
- The role of autophagy-related 1 in neuron morphology., Diaz, C., and Grueber, W., Annual International Symposium, RNA Structure and Function, New York, NY, 2011
- The role of somatostatin agonist in regulating methamphetamine neurotoxicity., Diaz, C., Afanador, L, and Angulo, J.A., Hunter College Science Poster Day, New York, NY, 2010
- The endogenous product of inflammation prostaglandin J2 induces dopaminergic neuronal loss, microglia activation and progressive behavioral deficits in a murine model of Parkinson disease., Shivers, K.-Y., Diaz C., Machlovi, S., Ordonez, D., and Figueiredo-Pereira, M. E., Society for Neuroscience 42nd Annual Meeting, New Orleans, LA, 2012
- Prostaglandin J2-induced progressive model of Parkinson disease., Shivers, K.-Y., Diaz C., Machlovi, S., Ordonez, D. G., and Figueiredo-Pereira, M. E., 13th Research Centers in Minority Institutions (RCMI) International Symposium on Health Disparities, San Juan, PR, 2012
- Duration of sickness behavior following endotoxin in aged and adult animals., Setti, S., Diaz C., Jones A. and Kohman R., 2014
- Clinical and Molecular Epidemiology of Colonizing Group B Streptococcal Isolates in Pregnant Women of Northwest Louisiana., Butler, K., Smith, C., Donna, R., and Vanchiere, J., 2020
Languages
Spanish
Native/ Bilingual
Timeline
Clinical Research Site Manager
Cross Creek Medical Clinic, PA
10.2025 - Current
Clinical Research Coordinator
The Geneva Foundation
07.2021 - 10.2025
Customer Service Representative
Walgreens
04.2021 - 08.2021
Research Assistant II
LSU Health Shreveport
05.2020 - 10.2020
Research Assistant II
LSU Health Shreveport
01.2018 - 10.2020
Research Assistant II and Lab Manager
UT Southwestern Medical Center
08.2015 - 10.2017
Laboratory Assistant
Sanford Burnham Medical Research Institute
03.2014 - 07.2015
Research Assistant
University of North Carolina Wilmington
03.2013 - 03.2014
Research Assistant
Ichan School of Medicine at Mount Sinai
05.2012 - 02.2013
Research Assistant
Hunter College of the City University of New York
01.2012 - 05.2012
Summer Intern
Columbia University
05.2010 - 08.2010
Research Assistant
Hunter College of the City University of New York
03.2009 - 01.2012
MASTERS OF PUBLIC HEALTH ADMINISTRATION -
Louisiana State University Shreveport
BACHELOR OF ARTS - PSYCHOLOGY
Hunter College of the City University of New York
EMERGENCY MEDICAL TECHNICIAN -
Bergen County EMS Training School