Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SENI SAFIDIYA

Joppa,MD

Summary

Results-driven Clinical Research Coordinator with 5+ years of experience managing clinical trials from initiation to closeout. Proven expertise in patient screening, enrollment, data collection, and regulatory compliance. Skilled in ICH-GCP, FDA regulations, and ensuring patient safety and protocol adherence.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Clinical Research Associate I

PolyCra
San Antonio, TX
01.2024 - Current
  • Conducted 10+ site visits (PSV, SIV, IMV) ensuring GCP and protocol compliance.
  • Monitored multi-site patient enrollment progress, contributing to a 25% increase in recruitment efficiency.
  • Verified source data for accuracy (SDV), achieving zero critical findings in audits.
  • Authored comprehensive monitoring visit reports within 24-48 hours, improving sponsor communication.
  • Oversaw investigational product accountability with 100% reconciliation at each visit.
  • Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.

Clinical Research Coordinator

Polycraft
San Antonio, TX
07.2019 - 12.2023
  • Managed 5+ Phase II & III clinical trials, ensuring compliance with FDA, GCP, and protocol standards.
  • Screened and enrolled 75+ patients, achieving a 90% retention rate through proactive patient engagement.
  • Led the informed consent process, resulting in zero protocol deviations related to consent.
  • Documented and reported 100% of Serious Adverse Events (SAEs) within regulatory timelines.
  • Resolved 100% data queries within 48 hours, maintaining audit-ready data quality standards.
  • Coordinated with PIs and sponsors across multiple study sites, facilitating study drug administration and imaging procedures.
  • Maintained up-to-date Trial Master Files, achieving zero findings during monitoring visits.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
  • Reviewed CRFs for completeness and accuracy before database entry.

Education

Bachelor of Science - Agricultural Engineering

Federal University of Technology Akure
Nigeria
05-2010

Master of Science - Clinical Research Management (Regulatory Science)

Arizona State University
Tempe, AZ

Skills

  • Clinical Trial Coordination
  • Patient Screening & Enrollment
  • Informed Consent Process
  • FDA & ICH-GCP Compliance
  • Regulatory Documentation & IRB Submissions
  • Adverse Event (SAE/AE) Reporting
  • Source Data Verification (SDV) & Review (SDR)
  • Electronic Data Capture (EDC) Systems
  • Clinical Trial Management Systems (CTMS)
  • CAPA Implementation & Protocol Deviation Management
  • Multisite Collaboration & Communication
  • Trial Master File Maintenance
  • Data Accuracy & Query Resolution
  • Project & Time Management
  • Microsoft Excel

Certification

  • GCP Certification
  • Basic Life Support (BLS) Certification, American Health Training, (2024)
  • Advanced ICH-GCPCertification (AGCPC), CCRPS (2024)
  • CITI Clinical Research Associate Program (2024)
  • Project Management Professional (PMP), Project Management Institute (PMI)- 2022
  • Microsoft Project Fundamentals, GoSkills (2023)

Timeline

Clinical Research Associate I

PolyCra
01.2024 - Current

Clinical Research Coordinator

Polycraft
07.2019 - 12.2023

Bachelor of Science - Agricultural Engineering

Federal University of Technology Akure

Master of Science - Clinical Research Management (Regulatory Science)

Arizona State University

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