Stanley A.

Lead Clinical Research Coordinator at OnSite Clinical Solutions, LLC
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Contact Information
us****@****om
(386) 825-5501
Location
Charlotte Metro

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Credentials

  • Good Clinical Practice
    National Institutes of Health (NIH): Intramural Research Program (IRP)
    Dec, 2021
    - Nov, 2024
  • IATA
    Mayo Clinic
    Dec, 2021
    - Nov, 2024
  • GCP
    Syneos Health
    Nov, 2021
    - Nov, 2024
  • COVID-19 Contact Tracing
    John Hopkins University
    Aug, 2021
    - Nov, 2024

Experience

  • OnSite Clinical Solutions, LLC
    • United States
    • Research Services
    • 1 - 100 Employee
    • Lead Clinical Research Coordinator
      • Jan 2023 - Present

      • Determine the source documentation requirements for pharmaceutical and medical device clinical research studies, ensuring accuracy and successful submission to regulatory authorities. • Compilation of comprehensive health data and obtaining vital signs, electrocardiograms, and lab specimens for Cardiology (Pharmaceuticals & Medical Devices) & Psychiatry clinical trials. • Manage the compilation and entry of clinical trial data into computer systems, and resolve queries accurately adhering to Standard Operating Procedures and FDA/ICH guidelines for data accuracy and integrity, as well as HIPAA regulations regarding data protocol. • Maintain compliance with GCP and ICH guidelines, ensuring that all regulatory requirements are met throughout the clinical trial process. Therapeutic Experience: Cardiology, Neurology and Medical Device Show less

  • New Hope Clinical Research
    • Lead Clinical Research Coordinator
      • Mar 2022 - Dec 2022

      • Managed clinical study protocols & files for 10+ Neurology & Psychiatry clinical studies with oversight of medical & nursing staff members; to ensure adherence to Good Clinical Practice guidelines andrecommended corrective actions in response to discrepancies throughout process.• Tracked & managed execution of 6+ concurrent research studies, ensuring adherence to regulatoryguidelines and patient confidentiality.• Utilized various medical technologies to provide preliminary diagnostic support and accuratelycomplete point-of-care assessments on clinical study patients.• Monitored and tracked patient safety data based on study criteria, identified and reported incidents ofserious adverse events to Principal Investigator with comprehensive documentation.Therapeutic Experience: Neurology & Psychiatry Show less

    • Clinical Research Coordinator
      • Dec 2021 - Mar 2022

      • Initiated studies, screen patients for study eligibility to participate as per protocol, inclusion/exclusion criteria and informed consent process.• Responsible for all data collection, source documentation, completing study-specific case report forms and submission of adverse events; recommend corrective action as appropriate• Data entry of visit procedures and trial drug accountability• Interacted with Principal Investigator to assure patients received appropriate medical evaluation, alerted Principal Investigator of serious adverse events, documented, and reported per all applicable protocol requirements• Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements• Maintained security and confidentiality under HIPAA, GCP, institutional human research regulations. Show less

  • Jackson Park Hospital
    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • MD Intern
      • Jan 2008 - Aug 2008

      Surgery Family Medicine Emergency Medicine Infectious Disease Radiology and Nuclear Medicine Hematology and Oncology Neurology Anesthesiology Ear, Nose and Throat Surgery Family Medicine Emergency Medicine Infectious Disease Radiology and Nuclear Medicine Hematology and Oncology Neurology Anesthesiology Ear, Nose and Throat

  • Adventist Hinsdale Hospital
    • Hinsdale, Illinois, United States
    • MD Intern
      • Aug 2007 - Dec 2007

      Obstetrics and Gynecology Psychiatry Pediatrics Obstetrics and Gynecology Psychiatry Pediatrics

  • WYCOFF HEIGHTS MEDICAL CENTER
    • United States
    • Medical Practices
    • 1 - 100 Employee
    • MD Intern
      • Mar 2007 - May 2007

      Internal Medicine Internal Medicine

Education

  • Uniwersytet Medyczny w Lublinie (Medical University of Lublin)
    ECFMG Certified Doctor of Medicine - MD, Medicine
  • Medical University of Lublin
    Bachelor's degree, PreMedicine/PreMedical studies

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