Gabrielle Seliber

Clinical Trial Associate at Reata Pharmaceuticals, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
US
Languages
  • English Native or bilingual proficiency
  • Russian Native or bilingual proficiency
  • Spanish Limited working proficiency

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Credentials

  • CRC Foundations
    CITI Program
    Oct, 2020
    - Nov, 2024
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices
    CITI Program
    Oct, 2020
    - Nov, 2024
  • Foreign Corrupt Practices Act (FCPA)
    CITI Program
    Jul, 2021
    - Nov, 2024

Experience

  • Reata Pharmaceuticals, Inc.
    • United States
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Clinical Trial Associate
      • May 2022 - Present

      - Facilitation and tracking of site enrollment, ongoing regulatory compliance, debarment, protocol deviation categorization and entry, lab samples, kit inventory, vendor access, ICF review and general study maintenance. - Liaison between clinical sites, vendors and internal departments for budget/contract negotiation, revision and approvals through established approval process. - Site/Subject invoice verification, payment, and reimbursement (Greenphire eGPS/Clincard). - Maintain CTMS & TMF - Lead project initiatives such as Laboratory Vendor Issue Tracking, DOA reconciliation, ISF Checklists

  • Reistone Biopharma
    • China
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Trial Assistant
      • Nov 2021 - Apr 2022

      - Execute regulatory, site selection, start-up and trial maintenance operations according to applicable federal regulations. - Perform quality control of documents filed in eTMF. Preparing, handling, distributing and filing clinical documentation and reports according to scope of work and assist with periodic review of study files. - Maintain the clinical trial management system, including contact database, monitoring visits, and invoice payments. - Responsible for trial vendor access relations, study user access, and documentation/compliance. (Veeva Vault TMF, Bioclinica CTMS, Calyx IRT, Labcorp Central Laboratory, EDC Medidata, Central & Local IRB) - Responsible for trial related IRB/Ethics Committee Safety Report submissions and tracking.

  • Ora, Inc.
    • United States
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Clinical Research Coordinator
      • Oct 2020 - Nov 2021

      - Collect and organize research information for clinical projects, while ensuring compliance with clinical project protocol and overall clinical objectives. - Perform clinical skills identified in trial SOP’s directly with subjects at a number of clinics across the United States. - Maintained comprehensive trial specific source documentation and regulatory accountability. - Partnered with Senior Clinical Research Coordinators and Clinical Project Managers to execute protocol directives, working cross functionally with internal and external teams such as Investigators and Sponsors.

  • Clinical Research Fastrack
    • Hospitals and Health Care
    • 100 - 200 Employee
    • Clinical Research Training
      • Sep 2020 - Sep 2020

      - ICH GCP Guidelines - FDA Regulations 21CFR11, 50, 54, 56 - Data Entry and Management - Informed Consent Process - Clinical Trial Operations - GDP following ALCOA-C principles - QA/Regulatory Affairs (Essential Docs) - Dissection of Protocol - Identification/Reporting of AEs & SAEs - ICH GCP Guidelines - FDA Regulations 21CFR11, 50, 54, 56 - Data Entry and Management - Informed Consent Process - Clinical Trial Operations - GDP following ALCOA-C principles - QA/Regulatory Affairs (Essential Docs) - Dissection of Protocol - Identification/Reporting of AEs & SAEs

  • Nuwellis, Inc.
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Clinical Research / Marketing
      • Jun 2019 - Sep 2020

      - Data entry for feasibility, retrospective, and pivotal studies into clinicaltrials.gov (PRRS). Reviewed pediatric registry study protocol and eCRFs prior to IRB submission. - Created digital data management process to increase accuracy/precision and avoid error for medical device feasibility study. - Aided in organization and review of eTMF documents/system health. - Oversaw Aquadex Flexflow​® System ​marketing material management/distribution. Aided new field hire on-boarding and tradeshow/event planning. Created Vendor Credentialing guide for field support and HR relief.

  • International Ophthalmology Consulting
    • Alicante, Spain
    • Administrative Assistant
      • Jan 2019 - May 2019

      - Inspected budget reports for financial accuracy. - Academic record keeping. Entered ophthalmology medical student grades/scores in a digital database. Coordinated and transcribed communications for ophthalmologist Dr. Jorge Alió, international pioneer and professor. - Work and communication fully in Spanish. - Inspected budget reports for financial accuracy. - Academic record keeping. Entered ophthalmology medical student grades/scores in a digital database. Coordinated and transcribed communications for ophthalmologist Dr. Jorge Alió, international pioneer and professor. - Work and communication fully in Spanish.

  • University of Minnesota, Department of Food Science and Nutrition
    • Greater Minneapolis-St. Paul Area
    • Laboratory Assistant
      • May 2018 - Dec 2018

      - Collected and analyzed data trend visuals. - Captured molecular research images using stained & polarized microscopy. - Handled complex, high tech. laboratory machinery (MVAG, HPLC, plasma, freeze dry, FTIR). - Collected and analyzed data trend visuals. - Captured molecular research images using stained & polarized microscopy. - Handled complex, high tech. laboratory machinery (MVAG, HPLC, plasma, freeze dry, FTIR).

  • University of Minnesota Department of Plant Pathology
    • United States
    • Higher Education
    • 1 - 100 Employee
    • Laboratory Assistant
      • May 2017 - Aug 2017

      Organized and labeled project seeds, plant handling and maintenance, and necessary field work for the continuation of wheat stem rust pathology research. Organized and labeled project seeds, plant handling and maintenance, and necessary field work for the continuation of wheat stem rust pathology research.

  • On-Site Care
    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Dental Hygienist Assistant
      • Jun 2015 - Aug 2016

      - Comprehension of patient confidentiality and HIPAA standards. - Assisted in geriatric dental care by determining premedication, equipment handling, and dental charting. - Coordination of geriatric patient retrieval for scheduled appointments at a multitude of senior-living facilities. - Comprehension of patient confidentiality and HIPAA standards. - Assisted in geriatric dental care by determining premedication, equipment handling, and dental charting. - Coordination of geriatric patient retrieval for scheduled appointments at a multitude of senior-living facilities.

Education

  • University of Minnesota-Twin Cities
    Biology Major, Spanish Minor, Biology/Biological Sciences, General
    2016 - 2020

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