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Elizabeth Kane

@elizabethkane

Clinical research and IRB quality assurance professional improving compliance, data integrity, and trial operations across cross-functional teams.

United States
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What I'm looking for

I’m looking for an IRB/regulatory-quality role where I can drive FDA/ICH-GCP compliance, strengthen documentation and data workflows, and partner with investigators to streamline study submissions and improve participant experience.

I’m a certified Clinical Research and Quality Assurance professional with over four years of experience in IRB coordination, clinical trials, regulatory compliance, and human subjects research. I ensure strict adherence to federal regulations (FDA, ICH-GCP, CFR) and internal SOPs while optimizing internal operations and strengthening stakeholder engagement.

In my IRB Coordinator + Quality Assurance Specialist role, I led IRB submissions and quality assurance reviews, coordinated meetings and expedited reviews, and partnered with PIs and research staff to resolve application deficiencies. I also managed document control systems (IRBManager, GlobeSync), trained new hires, and improved clarity and efficiency through client-facing guidance materials and SOP/process optimization.

Experience

Work history, roles, and key accomplishments

DR

Children's Ski Instructor

Diamond Peak Ski Resort

Nov 2025 - May 2026 (6 months)

Instructed children ages 3–12 in beginner-to-advanced alpine skiing through group and private lessons, adapting instruction to different skill levels while enforcing mountain safety. Supervised students on ski runs, supported equipment setup, and communicated lesson progress with parents and ski school staff while responding to changing weather and on-mountain situations.

SV

IRB Coordinator & QA Specialist

Salus IRB and Versiti

May 2023 - Jun 2025 (2 years 1 month)

Ensured FDA, ICH-GCP, and CFR compliance across IRB processes by conducting quality assurance reviews of submissions including protocols, amendments, consent forms, recruitment materials, and deviation reports. Coordinated IRB meeting agendas, facilitation, follow-ups, and expedited reviews, and resolved application deficiencies with PIs and research staff to meet review requirements.

PA

Research Associate & Coordinator II

PsyBrain Laboratory (UT Austin)

Oct 2022 - Feb 2023 (4 months)

Supported TRACK-TBI (NCT05201833) by recruiting and working with trauma head-injury patients in the emergency department, administering MoCA/WAIS/TMT, and completing informed consent. Processed blood using the Abbott i-STAT Alinity device, led 4-hour patient appointments, and entered/uploaded accurate participant data into EDC for scheduled follow-ups at 2 weeks, 6 weeks, 3 months, and 6 months.

MH

Clinical Research Coordinator II

Massachusetts General Hospital

Jun 2021 - Jul 2022 (1 year 1 month)

Facilitated in-person participant assessments across multiple MGH hospital sites and developed recruitment plans using REDCap surveys and data intake tools. Cleaned and managed large datasets with SQL and REDCap, supported IRB submission processes (including protocol preparation and de-identification), and maintained compliance with federal regulations and ICH-GCP.

AA

Care Coordinator / Case Manager

Aspire Health Alliance

Mar 2021 - Aug 2021 (5 months)

Developed individualized, person-centered care plans and coordinated services across healthcare providers, social services, and family systems. Facilitated access to appointments, transportation, and wraparound services while monitoring progress, reducing hospitalizations, and supporting care goal achievement.

Education

Degrees, certifications, and relevant coursework

University of New Hampshire logoUH

University of New Hampshire

Bachelor of Arts, Psychology

Bachelor of Arts in Psychology from the University of New Hampshire (Durham, NH), graduating in 2020.

Tech stack

Software and tools used professionally

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