Natalie Johnson
Senior Clinical Research Associate | Drug Accountability, Regulatory Documentation
- Role
- Senior Clinical Research Associate at Biorasi
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Natalie Johnson
6+ years in the Clinical Research Industry with experience in various therapeutic areas…
Experience
Senior Clinical Research Associate
Sep 2022 — Present · Atlanta, GA, US
Manages and monitors the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.• Executes project plans, budgets, monitoring visits, schedules, and trainings.• Provides expert level recommendations on data analysis, research, and public health.• Drafts, edits, and ensures proper facilitation of presentations, training initiatives, study policies and procedures for the Sponsor, and additional stakeholders.• Develops corrective action preventive action (CAPA) plans to assess risk and appropriate mitigation strategies. • Assists with the creation and development of policies to ensure all sites are following applicable standardization requirements.• Conducts scientific and clinical studies to support the development of public health initiatives to decrease disease, disability, and health disparities.• Reviews site budgets, in conjunction with finance, site marketing, legal documents, with applicable team members to ensure contracts are completed prior to study procedures.• Perform investigational product inventory reconciliation and ensure return of unused investigational product to designated location or verify destruction as required.• Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.• Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.• Measures and analyzes data outcomes to support public health initiatives, and treatment of diseases.• Consistently evaluates, and reviews regulatory products, regulations, guidance documents, SOPs, involving high level and sensitive data.
Education
Spelman College
Bachelor's degree
2010 — 2014
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