Cobe Ward
Nashville,TN
Summary
Detail-oriented and results-driven Clinical Trials Associate with 2 years of experience supporting clinical research operations in the diagnostics and healthcare industry. Currently contributing to the success of clinical trials at QuidelOrtho, a leader in diagnostic solutions, by managing trial documentation, ensuring compliance with regulatory requirements, and coordinating cross-functional teams. Proficient in clinical data management, monitoring, and maintaining study protocols, while ensuring accurate and timely reporting. Demonstrated expertise in supporting trial activities from initiation to closeout, improving operational efficiency, and ensuring adherence to Good Clinical Practice (GCP) guidelines. Adept at handling regulatory submissions, site management, and engaging with investigators to drive successful trial outcomes. Passionate about contributing to the development of diagnostic solutions that improve patient care.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Trials Associate
QuidelOrtho Corporation
05.2023 - Current
- Train clinical trial and marketing study site staff on study protocols, diagnostic devices, data management, and workflow during site initiation visits (SIVs), interim monitoring visits (IMVs), and study closeout visits (COVs).
- Monitor clinical trials both on-site and virtually, utilizing Clinical Trial Management Systems (CTMS) to ensure compliance and timely progress.
- Perform immunoassay and molecular testing using both QuidelOrtho and competitor assays for ongoing clinical trials, marketing studies, and internal initiatives, ensuring data accuracy and reliability.
- Collaborate with Technical Support to evaluate and test samples related to customer complaints, followed by data analysis and comprehensive reporting of findings.
- Manage and audit clinical trial comparator testing data, leveraging Microsoft Excel and in-house data scripts to ensure data integrity and accuracy.
- Coordinate acquisition, management, and shipment of materials for clinical trials and marketing studies, including inventory tracking and warehouse management to support trial operations.
Laboratory Assistant
QuidelOrtho Corporation
02.2023 - 05.2023
- Audit clinical trial data for accuracy and compliance, supporting the Clinical Operations team with laboratory activities, including viral culturing, TCID50 testing, specimen aliquoting, reagent preparation, and performing simple to moderately complex assays under supervision.
Laboratory Assistant
Ohio University-Microbiology Support Lab
01.2023 - 05.2023
- Prepared growth media, reagents, bacterial cultures, and scientific instruments to support microbiology courses at Ohio University, ensuring readiness for experiments and classroom activities.
Support Staff
Sheridan Funeral Home
01.2021 - 12.2023
- Via an-call schedule, I performed the removal and transport of the deceased on behalf of Sheridan Funeral Home. I also aided the Funeral Directors in the coordination and oversight of funeral-related activities. These activities included, but were not limited to, visitations, services, burials, cremations, and preparations for embalming.
Cadaver Prosection Lead
Ohio University Lancaster Campus-Biological Sciences Department
05.2022 - 08.2022
- Led the full prosection of a human cadaver and partial prosection of another, demonstrating expertise in anatomical dissection and preparation for educational purposes.
- Assisted in teaching Nursing Anatomy and Physiology I & II, including creating quizzes, providing one-on-one student support, and leading weekly recitation sessions to reinforce course material.
Treasurer and Community Relations Officer
Ohio University Regional Campuses-Regional Science Club
01.2022 - 08.2022
- -I am one of the founding Officers of the Regional Science Club (RSC). The RSC functions to provide science majors enrolled at the Ohio University regional campuses a means of collaboration, professional exposure, program advising, and academic support.
- - I was responsible for managing the RSC's finances, communicating and collaborating with organizations and patrons, and tutoring for courses related to the biological sciences.
Education
Bachelor of Science - Biological Sciences
Ohio University
Athens, OH05-2023
Minor in Chemistry -
Ohio University
Athens, OH05-2023
Associate in Science -
Ohio University
Athens, OH12-2019
Skills
- Good Clinical Practice
- Study Monitoring
- Research Coordination
- Clinical Data Management
- Clinical Trial Management Systems (CTMS)
- Trial Master File (TMF)
- PCR
- Materials Management
- Teamwork
- Presentation Skills & Audience Engagement
Certification
GCP for Clinical Investigations of Devices - CITI Program - August 2026
IATA - CITI Program - June 2026
Bloodborne Pathogens and Lab Training - Ohio University - June 2025
Chemical Hygiene Training - Ohio University - June 2025
Public Company Contributions
ASM-Clinical Virology Symposium - 2023 Poster
Evaluation of Rapid Multiplexed Real-Time PCR Platform for Detection of HSV-1, HSV-2, VZV, and T. pallidum in Clinical Specimens
ASM-Microbe - 2024 Poster
Evaluation of Rapid Multiplexed Real-Time PCR Platform for Detection of HSV-1, HSV-2, and VZV in Clinical Specimens
Timeline
Clinical Trials Associate
QuidelOrtho Corporation
05.2023 - Current
Laboratory Assistant
QuidelOrtho Corporation
02.2023 - 05.2023
Laboratory Assistant
Ohio University-Microbiology Support Lab
01.2023 - 05.2023
Cadaver Prosection Lead
Ohio University Lancaster Campus-Biological Sciences Department
05.2022 - 08.2022
Treasurer and Community Relations Officer
Ohio University Regional Campuses-Regional Science Club
01.2022 - 08.2022
Support Staff
Sheridan Funeral Home
01.2021 - 12.2023
GCP for Clinical Investigations of Devices - CITI Program - August 2026
IATA - CITI Program - June 2026
Bloodborne Pathogens and Lab Training - Ohio University - June 2025
Chemical Hygiene Training - Ohio University - June 2025
Bachelor of Science - Biological Sciences
Ohio University
Minor in Chemistry -
Ohio University
Associate in Science -
Ohio University
Similar Profiles
Rocco CampanaleRocco Campanale
Serology Technician at QuidelOrtho CorporationSerology Technician at QuidelOrtho Corporation
Talia DominicTalia Dominic
Assay Development Associate II at QuidelOrtho CorporationAssay Development Associate II at QuidelOrtho Corporation
Maritza GutierrezMaritza Gutierrez
Accounting Associate III at QuidelOrtho CorporationAccounting Associate III at QuidelOrtho Corporation