Public Health Clinical Trial

BERGONIAS SESSOU

Minneapolis, MN ***************@*****.*** 720-***-****

Master of Public Health with 2+ years driving data-driven population-health initiatives and regulatory compliance, clinical trial management, and public health research. Expert in protocol development, program evaluation, and community interventions—adept at transforming complex data into policy-shaping insights.

CORE COMPETENCIES

- Program Evaluation & Performance Metrics - Health Equity & Policy Implementation

- Data Visualization (SAS STATA) - Stakeholder Engagement & Communications

- Regulatory Affairs & IRB Compliance (FDA COMIRB ICH-GCP) - Process Optimization & Systems Thinking

- Community Outreach & Stakeholder Engagement - Research Infrastructure & Lifecycle PROFESSIONAL EXPERIENCE

Research Coordinator (Regulatory & Compliance) Nov 2022 - Present University of Colorado Anschutz Dept. of Ob/Gyn Remote

● Managed the full regulatory lifecycle for 250+ studies, including industry-sponsored, federally funded, and local projects, ensuring 100% compliance with IRB deadlines.

● Streamlined 30+ FDA & ClinicalTrials.gov submissions, cutting document turnaround time by 20%.

● Drafted, reviewed, and executed 50+ Material Transfer Agreements (MTA), Confidential Disclosure/Non-Disclosure Agreements

(CDA/NDA), and Data Use Agreements (DUAs) facilitating multi-institutional research collaborations while maintaining 100% adherence to institutional and federal guidelines.

● Served as lead liaison for 40+ investigators across industry, federal, and investigator-initiated protocols.

● Established and maintained comprehensive data records for 300+ clinical trials, achieving 99% data accuracy through meticulous tracking and quality control procedures.

● Developed SOPs, trained staff, and presented compliance updates at department-wide faculty meetings, increasing understanding of clinical trial guidelines and reducing protocol violations by 15%.

● Acted as primary contact for regulatory troubleshooting, and sponsor coordination. Public Health Research Assistant Jun 2023 - Nov 2023 NIH-Funded Peer Navigator Project University of Zambia Lusaka, Zambia

● Developed and piloted a peer-navigator intervention to raise PrEP & contraception awareness among 200+ students.

● Conducted qualitative focus groups and surveys; analyzed data in SAS/STATA and Atlas.ti to inform Ministry of Health policy briefs.

● Assisted in manuscript preparation with data-driven insights for publication, demonstrating the effectiveness of the intervention.

● Collaborated with local researchers and healthcare professionals to navigate regulatory and cultural considerations in research implementation. Contact Tracer Oct 2021 - Oct 2022

Colorado Department of Public Health & Environment Aurora, CO

● Mapped COVID-19 transmission clusters and hotspots; insights informed targeted interventions that reduced local outbreak spread by 15%.

● Automated weekly trend reports; improved data accuracy/timeliness by 20% through process enhancements.

● Synthesized interview data to identify clusters of infections and emerging hotspots, supporting targeted public health interventions. Provider Relations Associate Analyst Oct 2020 - May 2021 Cigna Behavioral Health Minnetonka, MN

● Guided 30+ healthcare providers weekly on eligibility, benefits, and authorization requirements, ensuring accurate and timely service delivery.

● Resolved 85% of claims processing issues on first contact, reducing follow-up inquiries and enhancing provider satisfaction.

● Implemented monthly compliance updates, maintaining 100% accuracy in information dissemination across the department. EDUCATION

Master of Public Health, Maternal & Child Health; Global health Graduated Dec 2023 University of Colorado Anschutz School of Public Health Bachelor of Science, Health Service Management; Minor in Public Health Graduated May 2020 University of Minnesota, Twin Cities

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