Kenechukwu Ibeanu
Bayonne,NJ
Summary
Detail-oriented and proactive Clinical Research Associate with 6 years of experience in Phase I–III clinical trials. Skilled in site monitoring, regulatory compliance, subject safety oversight, and ensuring adherence to GCP, ICH, SOPs, and study protocols. Strong background in eCRF review, query resolution, TMF maintenance, and vendor coordination. Proven ability to build strong site relationships and support high-quality, timely study execution.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
Memorial Sloan Kettering Cancer Center
New York, NY
06.2023 - Current
- Conduct routine site monitoring visits (SIVs, IMVs, COVs) in accordance with protocol, GCP, and SOPs.
- Perform source data verification and ensure accurate and timely entry of eCRF data.
- Track AEs/SAEs, ensuring timely reporting, documentation, and follow-up with investigators.
- Review regulatory essential documents and contribute to maintaining a complete and audit-ready TMF.
- Assess site performance, identify risks, and implement corrective and preventive actions (CAPA).
- Provide continuous site training on protocol updates, GCP, and compliance issues.
- Collaborate with project teams, data management, and vendors to support study timelines.
- Prepare detailed monitoring reports and follow-up letters within required timelines.
Clinical Study Coordinator
University of Arkansas
Little Rock, AR
03.2019 - 05.2023
- Collaborated with Principal investigators (PI), nurses, and data managers to ensure smooth trial operations.
- Monitored subject adherence to study protocols and managed follow-up visits.
- Reported adverse events (AEs) and serious adverse events (SAEs) following protocol and regulatory guidelines.
- Assisted with patient recruitment, screening, informed consent, and study visits
- Supported monitoring visits and protocol compliance at the site level
Research Assistant
University of Arkansas
Little Rock, AR
06.2016 - 01.2019
- Managed inpatient care log, documenting patient medical history, diagnoses, and medications.
- Utilized hospital systems to monitor and report on individual patient care, including lab results, allergies, and vital signs.
- Provided actionable insights through detailed reports to enhance patient care and operational experience.
Specialist Outreach Coordinator
Color Purple Inc
Pine Bluff, AR
04.2015 - 05.2016
- Facilitated community outreach programs and mentorship initiatives, strengthening organizational presence.
- Revised content based on feedback from the lupus community, ensuring relevance and impact.
- Implemented search optimization strategies and collaborated with professionals to promote visibility.
Education
Master of Arts - Biology
University of Arkansas
Little Rock, AR12.2023
Bachelor - Medical Laboratory Science
Imo State University
Imo State, Nigeria11.2014
Skills
- Clinical Data Management Software (eg REDCap, ClinigenDirect, Clarion, Suvoda and Medidata)
- Vendor and Site Coordination
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Electronic Medical Record (EMR) Systems
- Protocol Information Management Systems (PIMS)
- Risk-Based monitoring (RBM)
Certification
Good Clinical Practice (GCP) Certification, Infection Prevention and Control Training Certification , Human Subject Protection (HSP) Certification
Affiliations
Good Clinical Practice (GCP) Certification, Infection Prevention and Control Training Certification , Human Subject Protection (HSP) Certification
Languages
English
Native or Bilingual
Igbo
Native or Bilingual
Timeline
Clinical Research Associate
Memorial Sloan Kettering Cancer Center
06.2023 - Current
Clinical Study Coordinator
University of Arkansas
03.2019 - 05.2023
Research Assistant
University of Arkansas
06.2016 - 01.2019
Specialist Outreach Coordinator
Color Purple Inc
04.2015 - 05.2016
Master of Arts - Biology
University of Arkansas
Bachelor - Medical Laboratory Science
Imo State University
Core Competencies
Communication skills, Computer literacy, Leadership, Time management, Good Clinical Practice, Infectious Diseases, Organizational Skills, Data Management, Participant Recruitment & Informed Consent