Jhande Gardiner
Forney,TX
Summary
Accomplished Clinical Research Professional with a robust background in overseeing project timelines, and cross-functional teams within clinical operations. Demonstrated expertise in identifying and mitigating risks, ensuring stringent regulatory compliance, and fostering productive sponsor communication to achieve study and program objectives. Current Clinical Research Coordinator with hands-on experience managing 26 different Phase 1 clinical research studies in various therapeutic areas, offering a comprehensive understanding of clinical trial processes, site management and meticulous attention to detail. Seeking to leverage extensive skills and knowledge of day-to-day site conduct to deliver accurate and realistic timelines, and overall client satisfaction in a dynamic Project Manager role with a strong focus on facilitating smooth project execution, supporting senior PMs, and driving efficiency in all aspects of project administration.
Overview
5
5
years of professional experience
Work History
Clinical Research Coordinator II
Fortrea Clinical Research Organization (CRO)
Dallas, TX
06.2021 - Current
- Managed sponsor expectations and served as the primary point of contact between site teams, sponsors, and vendors, ensuring alignment with SOPs, program objectives, GCP/ICH guidelines, and regulatory requirements, while maintaining clear communication of project progress, issues, and resolutions throughout the trial lifecycle.
•Supported project managers in the creation and development of study protocol, informed consent document, electronic case report forms completion guidelines, protocol deviation definitions, risk registrar and source documents.
•Drafted site-specific IRB documents as well as reviewed and provided input on all IRB submitted documents.
•Participated in the review, development and testing of study eSource and electronic database.
•Led site wide clinical planning meetings, ensuring thorough review of study protocol, logistics and potential risks. Created meeting agendas, presentations and tracked follow up action items from meetings. Coordinated follow-up communications to ensure timely implementation of decisions made during the meetings.
•Created and managed site profiles for multiple third-party vendors, such as shipment pick-up, central lab services, and cardiac analysis. Coordinated with vendors to ensure timely delivery of necessary supplies to the site.
•Utilized Study Management Accountability and Responsibility (SMART) Tool to track site adherence to project milestones ensuring successful on-time deliverables.
•Provided training to study staff on protocol requirements and GCP regulations. Coordinated with internal teams to achieve efficient study execution and supported milestone achievements.
•Proactively identified operational risks and collaborated with internal teams to develop and implement risk mitigation strategies. Tracked implementation of resolution from start to finish and conducted efficacy checks.
•Attended weekly sponsor calls and effectively communicated vital information including sponsor goals and study deadlines to relevant internal staff members. Reported project status through weekly sponsor call, providing key site updates including weekly patient recruitment/study enrollment and adverse event updates.
•Proactively identified situations required deviation from the protocol or SOPs and ensured appropriate documentation of these deviations for eTMF.
•Worked closely with CRAs to achieve query resolution within the electronic database capture system and successful eTMF maintenance and reconciliation of project document files.
•Key member of quality assurance audits at site to ensure adherence to protocols, SOPs, regulations, guidelines.
Research Technician II
Fortrea Clinical Research Organization (CRO)
Dallas, Texas
10.2019 - 06.2021
- Demonstrated proficiency in key clinical skills including vital sign assessment, ECG performance, phlebotomy procedures, and dosage administration.
•Managed scheduling and execution of screening appointments and outpatient visits.
•Reviewed screening charts to determine if participants met eligibility requirements at check-in.
•Documented subject's AEs and communicated updates to physicians.
•Managed data collection and documentation processes to ensure accuracy and consistency.
•Ensured adherence to good clinical practices guidelines throughout all study phases.
Education
Master of Science - Biomedical Sciences
University of The Incarnate Word
San Antonio, TX05-2020
Bachelor of Science - Genetics
Texas A&M University
College Station, TX05-2018
Skills
- Regulatory Compliance (GCP/ICH)
Medidata, CIMS, and Veeva Experience
Risk Management
Client Relationship Management
Site Management
MS Excel
MS Word
- Detail-Oriented and Critical Thinker
Task Prioritization
Self-Motivation
Effective Communication
Accountability and Urgency
MS PowerPoint
MS Project
Accomplishments
- Fortrea Dallas Employee of The Month February 2023
• Global CPS Cultural Belief of “Customer Connect” December 2023
o This recognition is awarded to individuals who drive a proactive approach to deliver successful outcomes.
Timeline
Clinical Research Coordinator II
Fortrea Clinical Research Organization (CRO)
06.2021 - Current
Research Technician II
Fortrea Clinical Research Organization (CRO)
10.2019 - 06.2021
Master of Science - Biomedical Sciences
University of The Incarnate Word
Bachelor of Science - Genetics
Texas A&M University
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