Danijela Gregory, CCRA

Clinical Research Associate/Auditor at Levine Cancer Institute
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Monroe, North Carolina, United States, US
Languages
  • English Full professional proficiency
  • Serbian Native or bilingual proficiency
  • Croatian Native or bilingual proficiency
  • Bosnian Native or bilingual proficiency
Skills

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • CCRA
    Association of Clinical Research Professionals
    Apr, 2015
    - Oct, 2024
  • CCRC
    Association of Clinical Research Professionals
    Mar, 2008
    - Oct, 2024

Experience

  • Levine Cancer Institute
    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • Clinical Research Associate/Auditor
      • 2012 - Present

      − Verify research site personnel, including investigators, are conducting the study according to the clinical protocol, Good Clinical Practices, and regulatory requirements. − Verifying that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification). − Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools). − Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC. − Verify Investigational Product accountability. − Conduct remote monitoring and routine monitoring visits by traveling to local sites when needed. − Prepare for FDA, Sponsor, and NCI Cooperative Group (SWOG, NSABP, RTOG, COG, GOG etc.) audits. − Develop training materials for LCI research stuff identified through risk based monitoring. − Perform training for new employees and refresher training for existing employees. − Assist with organization of annual Research Academy. − Create and edit SOPs. − Attend Research Conferences. Show less

  • Carolinas HealthCare System
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Oncology Research Data Coordinator
      • 2011 - 2012

      − Managed data of Phase I, II, III, Melanoma and Renal Cell Carcinoma studies. − Completed Case Report Forms (CRFs) and query resolutions within various electronic data capture systems. − Collected and submitted pertinent information from subject’s chart and other source documents on appropriate data forms/flow sheets/databases. − Maintained subjects’ shadow charts with appropriate source documentation. − Ensured accuracy and timeliness of subject data in clinical trials software programs. − Prepared data for research audits. − SAE filing and follow-up. − Coordinated the collection, preparation and shipping of all biological samples. Show less

  • PMG Research
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Certified Clinical Research Coordinator II
      • 2006 - 2011

      − Adhered to the study protocol. Maintained proper documentation according to the protocol, regulatory requirements, and internal SOPs. Complied with all federal and local regulatory requirements, sponsors, protocol requirements and company procedures.− Performed study start-up duties including the production of a phone screener, progress notes, as well as phone screening patients.− Developed and executed recruitment plans that generate randomized patients and maximizing patient retention rates.− Performed technical requirements i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, hep-locks, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.− Performed continuous review reports as well as any IRB related documents.− Established strong relationships with PIs, Monitors and Sponsors.− Prepared study documentation in the event of a sponsor or FDA audit.− Internally monitored and reviewed charts of other coordinators and support staff. Show less

    • Laboratory Research Coordinator
      • 2004 - 2006

      − Collected, processed and shipped all laboratory samples to various central laboratories. − Organized storage rooms. Preformed inventory and ordered all laboratory and clinical supplies. − Assisted all research coordinators with clinical procedures as time permitted. − Complied with OSHA regulations. − Maintained freezer and refrigerator

Education

  • University of Belgrade
    Bachelor's Degree, Molecular Biology and Physiology
    1994 - 2001

Community

You need to have a working account to view this content. Click here to join now