Karina Ordonez, BS
Pfafftown,NC
Summary
Clinical Research Coordinator with experience in Phase I, III, and observational studies. Therapeutic areas include Women's Health, Knee Osteoarthritis, preclinical Alzheimer's, Hyperlipidemia, Hypertension, Influenza Vaccine and COVID-19 Vaccine. Extensive experience interviewing diverse populations to collect statistical data for a federal agency. Experience with post-market medical device regulatory submissions. Bachelor of Science in Biology with an emphasis in pre-medical studies.
Overview
9
9
years of professional experience
Work History
Regulatory Reporting Specialist [Contract]
Kelly Science and Clinical/Johnson & Johnson
Remote , NC
2023.06 - Current
- Submit MedWatch reports to the FDA in compliance with regulations, guidelines, and required timeframes.
- Initiate audit corrections and solicit additional information to ensure all complaints are processed per established company procedures and applicable standards.
- Assist the Joint Reconstruction Health Authority Reporting team with assigned projects.
Virtual Screening Associate
Care Access Research
Remote , NC
2022.05 - 2023.01
- Performed remote screening visits and E-Consenting for an early Alzheimer's study.
- Scheduled on-site lab visits and served as a liaison between patients and remote CRCs.
- Completed CRFs, EDC, and other post-study activities.
Clinical Research Coordinator
Wake Forest University Health Sciences
Winston-Salem , NC
2021.07 - 2022.05
- Collaborated with PI, sponsors, and CROs to facilitate trial activities and comply with research protocols.
- Recruited, screened, and randomized eligible subjects into Cardiology studies.
- Monitored patients for adverse events following the administration of the study medication.
Clinical Research Coordinator
Accellacare
Winston-Salem , NC
2020.11 - 2021.07
- Managed Regulatory binder, collected essential documents and completed IRB submissions.
- Managed trials throughout their entire lifecycle: from initiation, through ongoing maintenance, to final closure.
- Tracked and reported adverse events, protocol deviations and completed appropriate logs.
- Covered patient visits amidst multiple CRC resignations and helped train new staff, naive to clinical research.
Clinical Research Coordinator
Unified Women's Clinical Research
Winston-Salem , NC
2019.03 - 2020.11
- Recruited patients from OB-GYN clinic for Women's Health studies.
- Maintained the appropriate storage, dispensing, and tracking of investigational products and trial-related materials.
- Gathered vital signs and collected lab specimens to support testing procedures.
- Arranged medical equipment and instruments to assist physicians during the examination and care of study participants.
- Managed multiple trials effectively despite a 1/3 reduction in workforce during the COVID pandemic.
- Clinical Research Assistant 03/2019 - 03/2020
- Commuted between two cities to assist CRCs with administrative tasks such as inventory and ordering supplies.
- Ordered catering for meeting and conference attendees.
- Processing and shipping of lab specimens.
Field Representative
U.S. Census Bureau, Dept. of Commerce
Winston-Salem , NC
2015.04 - 2019.03
- Statistical data collection for The Centers for Disease Control and Bureau of Labor & Statistics.
- Adhered to confidentiality laws, and exhibited cultural sensitivity while interviewing diverse populations.
- Supported non-English speakers by translating census materials and ensuring comprehension.
Education
Regulatory Affairs Training Program -
Duke University
Remote, NC 05.2023
BS, Biology -
Winston Salem State University
Winston-Salem, NC05.2018
Skills
- FDA Regulatory Submissions
- Good Clinical Practice
- Informed Consent
- Clinical Trial Management Systems
- Medical Terminology
- Electronic Medical Records
- Medical Device Regulation
- Recruitment
- Microsoft Office
- Bilingual: English/Spanish
Electronic Systems
Medidata Rave, Medrio, Oracle, Bioclinica, Veeva, Y-Prime, Suvoda, ERT, CRIO, Clinical Conductor, StudyTeam, Study Hub, Advarra, Athena, EPIC, Salesforce
Timeline
Regulatory Reporting Specialist [Contract]
Kelly Science and Clinical/Johnson & Johnson
2023.06 - Current
Virtual Screening Associate
Care Access Research
2022.05 - 2023.01
Clinical Research Coordinator
Wake Forest University Health Sciences
2021.07 - 2022.05
Clinical Research Coordinator
Accellacare
2020.11 - 2021.07
Clinical Research Coordinator
Unified Women's Clinical Research
2019.03 - 2020.11
Field Representative
U.S. Census Bureau, Dept. of Commerce
2015.04 - 2019.03
Regulatory Affairs Training Program -
Duke University
BS, Biology -
Winston Salem State University
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