Summary
Overview
Work History
Education
Skills
Certifications Training
Therapeutic Areas
References
Timeline
Generic

NANCY ASUNI

Peachtree Corners,GA

Summary

Detail-oriented Clinical Research professional with extensive experience in healthcare IT support and clinical trial monitoring. Proven ability to enhance trial procedures and ensure data integrity through effective communication and proactive problem-solving. Demonstrated expertise in participant recruitment, regulatory compliance, and managing multiple tasks efficiently, supported by strong organizational skills. Committed to advancing clinical research practices while maintaining strict adherence to protocols.

Overview

7
7
years of professional experience

Work History

Clinical Research Coordinator II

Smiths Medical Center
11.2023 - Current
  • Responsible for coordinating all aspects of clinical trials with strict adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocols, regulations, and policies
  • Scheduled collection of data, documented and reported adverse events, protocol deviations, and other unanticipated problems appropriately
  • Reviewed and tracked study essential documents such as IRB approvals, CVs, investigator licenses, and board certifications/lab certifications
  • Analyzed and logged clinical data using EDC systems, ensuring data integrity and consistency
  • Performed administrative and regulatory duties as appropriate
  • Updated product/accountability logs, ensuring the site received accurate information and supplies from sponsors (source, protocol, scales, supplies, approvals, contacts)
  • Educated potential participants and caregivers on protocol-specific details and expectations
  • Addressed specific inclusion/exclusion criteria questions, including responding to safety questions
  • Thoroughly reviewed informed consent documents (ICFs) to ensure consent was obtained and documented appropriately
  • Documented and tracked all outstanding site-specific protocol-related issues
  • Monitored Serious Adverse Events (SAEs) and Adverse Events (AEs) reporting, ensuring adherence to protocol
  • Performed safety activities in compliance with regulatory authorities (local or global) reporting requirements, including external and internal safety audits

Clinical Research Coordinator

Dumog Research
02.2021 - 11.2023
  • Supported the Clinical Operations teams with the ongoing conduct of studies
  • Assisted project teams with study-specific documentation and guidelines as appropriate
  • Set up, organized, and maintained clinical study documentation (e.g., Main Study Files, CRFs, etc.), including preparation for internal/external audits, final reconciliation, and archival
  • Processed Data Collection Forms, including log-in, tracking, and quality control, as appropriate for the study
  • Reviewed study records, including case report forms, informed consent forms (ICF), and other materials
  • Reviewed and tracked study essential documents such as IRB approvals, CVs, investigator licenses, and board certifications/lab certifications
  • Escalated observed deficiencies and issues and presented potential solutions, following all issues through to resolution
  • Facilitated subject enrollment and ICF process
  • Verified timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs)
  • Documented all findings and activities at the site and completed monitoring visit reports
  • Performed other clinical operations duties as necessary

Healthcare IT Support Experience
05.2018 - 11.2023
  • Provided technical support for EPIC and CERNER applications, ensuring seamless operation of electronic health records (EHR) and other healthcare IT systems
  • Assisted end-users with troubleshooting, system navigation, and resolving software and hardware issues in hospital and clinical settings
  • Conducted training sessions for healthcare professionals on system functionalities, workflow optimization, and regulatory compliance
  • Worked closely with clinicians and administrative staff to enhance system usability, reducing downtime and increasing operational efficiency
  • Managed and supported multiple healthcare IT modules, including Patient Registration, Scheduling, Billing, and Clinical Documentation
  • Collaborated with IT teams and vendors to implement software updates, system configurations, and troubleshoot complex system errors
  • Ensured data integrity and compliance with HIPAA regulations, protecting patient confidentiality and maintaining security protocols
  • Provided remote and on-site support for system upgrades, go-live support, and post-implementation troubleshooting
  • Analyzed and resolved EHR-related issues to enhance clinical workflows and improve patient care delivery

Education

Master of Business Administration -

University of South Wales
United Kingdom
01.2004

Bachelor of Law - Law

Obafemi Awolowo University
Ile-Ife Nigeria
10-1995

Skills

  • Progressive On-site monitoring experience with SQV, SIV, IMV & COV
  • Strong experience with GCP, FDA regulations and ICH guidelines
  • Clinical Trial Management
  • Regulatory Compliance (FDA, ICH-GCP, HIPAA)
  • Patient Recruitment & Retention
  • Data Management & Analysis
  • Informed Consent Process
  • Adverse Event Reporting
  • EDC Systems (Veeva)
  • Study Protocols & SOPs
  • Clinical Monitoring & Site Management
  • Medical Terminology & Documentation
  • Medical Research & Statistics
  • Strong Communication & Teamwork
  • Epic and Cerner Training Specialist

Certifications Training

  • Introduction to Clinical Research - IITA Institute
  • Clinical Research Associate (CRA) Trainee - IITA Institute
  • Good Clinical Practice and ICH Certificate - Collaborative Institutional Training Initiative (CITI)
  • Audit and Inspections of Clinical Trials - Collaborative Institutional Training Initiative

Therapeutic Areas

  • Medical Device (Class II/III)
  • Respiratory / Infectious Diseases - COVID-19 (Specimen Collection), COVID-19 (Phase 2)
  • Pediatrics – Endocrinology & Neurology

References

References available upon request.

Timeline

Clinical Research Coordinator II

Smiths Medical Center
11.2023 - Current

Clinical Research Coordinator

Dumog Research
02.2021 - 11.2023

Healthcare IT Support Experience
05.2018 - 11.2023

Master of Business Administration -

University of South Wales

Bachelor of Law - Law

Obafemi Awolowo University

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