Global Medical Information & Clinical Ops Leader

ROSE ALLEN-BASS

Global Medical Information & Clinical Research Operations Specialist

Roxboro, NC 27573 919-***-**** *********@*****.***

PROFESSIONAL SUMMARY

Strategic and detail-oriented Clinical Research professional with over 12 years of experience spanning Global Medical Information (GMI), Regulatory Compliance, and Site Operations. Proven track record in managing complex inquiry cases for pharmaceutical leaders and coordinating high-stakes trials at premier institutions like Duke Cancer Institute. Expert in navigating EMR/EDC systems and ensuring 100% adherence to FDA, IRB, and GCP guidelines.

CORE COMPETENCIES

● Systems: Veeva Vault (MedComms), Salesforce, SharePoint, EPIC, Athena, Rave EDC, InForm, eTMF, Oracle Clinical, Microsoft 365, Twilio Flex.

● Clinical Ops: Trial Start-up, Patient Recruitment & Enrollment, Adverse Event (AE) Reporting, Source Data Verification (SDV), Narrative Writing.

● Regulatory: IRB Submissions, Protocol Development, Site Essential Documents, FDA Compliance, Audit Readiness, Clinical Trial Assistant (CTA) Support.

PROFESSIONAL EXPERIENCE

Global Medical Information Operations Specialist Mindlance (Otsuka Pharma) 2022 – 2025

● Case Management: Managed end-to-end medical information inquiry lifecycles, ensuring global compliance and rapid response times for healthcare provider (HCP) requests.

● Safety Reconciliation: Executed Adverse Event (AE) reporting reconciliation between Medical Information and Pharmacovigilance to ensure seamless safety reporting.

● Operational Optimization: Maintained departmental SharePoint workflows and tracked KPIs/metrics to improve operational transparency for global leadership.

● Evidence Support: Conducted targeted literature database searches and managed article fulfillment to support evidence-based medical responses.

Virtual Study Concierge / Study Assistant Cynet Health (IQVIA) 2021 – 2022

● Remote Trial Support: Provided high-level clinical research support to virtual investigators and study staff, maintaining trial continuity in a decentralized environment.

● Site Onboarding: Facilitated site activation by training staff on virtual platforms and managing delivery and collection timelines for critical study materials.

Senior Clinical Research Specialist Grace Federal (Duke Cancer Institute) 2021

● Oncology Data Management: Supported Bone Marrow Transplant and Hematology programs through rigorous patient chart reviews and clinical data documentation.

● Data Accuracy: Entered study trial data into Electronic Data Capture (EDC) systems with a focus on audit readiness and protocol compliance.

Study Coordinator St. Vincent’s Spine & Brain Institute 2017 – 2020

● Patient Engagement: Successfully screened and consented patients for novel medical device studies, ensuring comprehensive understanding of study protocols.

● Regulatory Maintenance: Managed Excel tracking systems and clinical trial documentation, consistently maintaining "audit-ready" regulatory binders.

Clinical Trials Assistant I Quintiles/IMS (now IQVIA) 2016 – 2017

● Compliance Oversight: Monitored clinical systems for site performance and prepared essential documentation for regulatory reporting.

ADDITIONAL PROFESSIONAL EXPERIENCE

● Regulatory Document Specialist Unified Women’s Clinical Research 2016

● Clinical Research Coordinator II Kelly Services (Duke University Hospital) 2015 – 2016

● Research Regulatory Specialist St. Vincent’s HealthCare Inc. 2015

● Regulatory Document Specialist I InVentiv Health (J&J/Vistakon) 2014 – 2015

● Clinical Research Coordinator General Dynamics (Jacksonville Naval Hospital) 2012 – 2014

EDUCATION

● M.A. Human Service Counseling/Criminal Justice Liberty University

● B.S. Interdisciplinary Studies Liberty University

● A.A.S. Medical Office Administration / Business Administration Piedmont Community College

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