Data Management Clinical Research

Jennifer (Underhill) Garbarino, MA, CCRC

Clinical Monitor and Data Management Professional

************@*****.*** 919-***-**** Pittsboro, NC 27312 SUMMARY

Dynamic and strategic Clinical Monitor and data reviewer with over 15 years of experience driving successful clinical research operations. Adept at identifying and mitigating risk while championing subject safety across all study phases. Proven track record in data management, ensuring accuracy, reliability, and compliance in clinical documentation. Recognized for fostering cross-functional collaboration and serving as a trusted advocate for study subjects. Skilled mentor and trainer, accelerating new hire performance through targeted education and support. Detail-oriented Site Manager Associate, maintaining site readiness, organization, and regulatory compliance. CORE COMPETENCIES

●Data management

●Protocol deviation review and reporting

●Query creation

●Source document monitoring

●TMF auditing and review

●Investigational product auditing

●Report writing

●Risk-based monitoring

●Site risk assessment

●Case Report Form completion (EDC)

●Good Clinical Practice (GCP)

●Advocate for patients and/or their

guardians

●Proficient in Microsoft Office Suite

●Complete IRB documentation for

renewals and updates

● Regulatory Compliance

● Phase I – III Clinical Trials

●Clinical Trial Management Systems

(CTMS)

● Interactive Randomization

Systems (IRT)

EXPERIENCE

ICON plc. Raleigh, NC November 2024 – April 2025 Site Management Associate II (SMA II)

● Proactively managed active clinical sites through monthly outreach to track outstanding data, resolve queries, and ensure TMF document compliance.

● Reviewed and validated site documentation and informed consent forms (ICFs) to ensure alignment with GCP and study-specific requirements.

● Collaborated with sites to resolve clinical issues, escalating safety concerns and risk indicators to study leadership when necessary.

● Created and maintained document tracking systems for high-risk or complex sites, improving TMF accuracy and audit readiness.

● Developed organized, accessible documentation processes for new hires, enhancing onboarding efficiency and daily operational accuracy.

SYNEOS HEALTH, INC. Morrisville, NC April 2021-July 2024 Clinical Monitor II (CM II)

● Led central monitoring operations, evaluating risk indicators and escalating subject safety concerns to study leadership.

● Maintained study matrix and processed clinical data across multiple projects, ensuring clean, validated, and audit-ready records.

● Streamlined RECIST/iRECIST training and reporting, enabling 100% data maintenance within three days of site entry.

● Designed and implemented a successful mentoring program, achieving a 100% new hire success rate.

● Enhanced FDA audit readiness through detailed site data reviews and compliance-driven documentation practices.

LINEBERGER COMPREHENSIVE CANCER CENTER Chapel Hill, NC October 2016- March 2021 Lead Research Study Coordinator (SC3), Protocol Office

● Supported the full clinical trial lifecycle by managing visits, maintaining project documentation, and completing CRFs with accuracy and timeliness.

● Acted as liaison among investigators, sponsors, site staff, and university personnel, ensuring consistent communication and trial efficiency.

1

● Revitalized a struggling Phase I oncology department into a top-enrolling unit through strategic planning and SC3 standard implementation.

● Led Phase I and melanoma coordinator teams, assigning daily tasks and conducting staff training to optimize team performance.

● Spearheaded monthly meetings and policy development, accelerating study start-up timelines and supporting innovative oncology treatment protocols.

Chapel Hill, NC October 2016- October 2018

Phase 1 Research Study Coordinator

● Coordinated clinical study operations, collaborating with site staff, sponsors, and stakeholders to ensure GCP-compliant research execution.

● Supported study leadership by preparing participants, organizing critical materials, and facilitating smooth study start-up and conduct.

● Mentored site and study team members, delivering targeted task-specific guidance to improve performance and study efficiency.

SANFORD CARDIOLOGY Sanford, NC November 2009- September 2016 Lead Research Study Coordinator

● Directed end-to-end coordination of cardiology trials, from initial contact to study closeout, ensuring smooth and compliant operations.

● Managed vital study documentation, including CRFs, activity logs, and source records across both paper and electronic systems.

● Assessed site readiness and addressed operational concerns, assembling appropriate personnel to meet protocol requirements.

● Secured and maintained trial approvals by collaborating with central IRBs, ensuring full regulatory compliance. UNIVERSITY OF NORTH CAROLINA Chapel Hill, NC October 2006- October 2009 Research Study Coordinator, Division of Medicine and Cardiology

● Led coordination of cardiology trials with a focus on cardiac catheterization and electrophysiology labs, ensuring seamless operations.

● Secured and maintained IRB approvals for both industry-sponsored and physician-initiated studies, emphasizing protocol adherence and documentation accuracy.

● Assessed investigator-initiated trial requirements, supporting the development and integration of new study protocols.

EDUCATION

Master of Arts in Exercise Physiology The College of St. Scholastica Duluth, MN Bachelor of Science in Athletic Training, CAAHEP Sacred Heart University Fairfield, CT Phlebotomy Technician Certificate Central Carolina Community College Sanford, NC CERTIFICATIONS

Professional Rescuer First Aid/CPR Certification Active Automatic External Defibrillator (AED) Certification Active Protection of Human Research Subject CITI Certification Active Research Study Coordinator Certification Association of Clinical Research Professionals (ACRP) Active Dangerous Goods Shipment Certification IATA Active PUBLICATIONS

Underhill, J. (2005). Take charge of your profession: Exercise physiology. Professionalization of Exercise Physiology Journal Online. 8(4)

Garbarino, J. (2011). Insights into the inhibition of platelet activation by omega-3 polyunsaturated fatty acids: Beyond aspirin and clopidogrel. Thrombosis Research Journal. 10.1016/j.thromres.2011.04.023 2

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