Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Khrystyna Gomenyuk

Mississauga

Summary

Detail-Oriented Clinical Research Coordinator with hands-on experience supporting all phases of clinical trials in compliance with GCP, ICH, and FDA regulations. Skilled in patient recruitment, informed consent, phlebotomy, and data accuracy. Trusted for problem-solving, regulatory precision, and supporting patient safety and protocol compliance. Dedicated to delivering successful study outcomes with precision and efficiency.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Parental Leave

Baby Boss (Self- Managed)
03.2022 - Current
  • Took planned parental leave to care for two “chief executives,” developing advanced multitasking, organization, and time-management skills.
  • Stayed current with clinical research trends and best practices, now fully available and eager to return to a clinical role with renewed energy and focus.

Clinical Research Coordinator

DermEdge Clinical Research
03.2021 - 03.2022
  • Supported all phases of clinical trials, including patient screening, recruitment, and informed consent, ensuring compliance with GCP, ICH, and FDA guidelines.
  • Scheduled and conducted study visits; collected patient data in source documents and completed eCRFs/CRFs per protocol requirements.
  • Performed phlebotomy and on-site testing (e.g., vitals, ECGs); processed and shipped lab specimens while maintaining accurate logs and documentation.
  • Managed Investigational Product (oral and injectable): received, stored, dispensed, and documented per pharmacy manual; maintained Master IP logs.
  • Maintained Investigator Site File and patient binders; reported AEs/SAEs, supported monitoring visits, and trained patients on e-diaries to ensure compliance.

Pharmacy Assistant

Dundas Kipling Pharmacy
01.2020 - 07.2020
  • Assisted patients with prescription pick-up and transactions, maintaining professionalism and confidentiality.
  • Accurately filled prescriptions by verifying DINs, counting, labeling, and packaging medications.
  • Managed inventory by restocking, monitoring expiration dates, and verifying medication deliveries.
  • Communicated proactively with patients by phone to notify prescription readiness.
  • Ensured adherence to safety and storage protocols for all medications.

Pharmacy Assistant

Pharmasave Westdale Mall
09.2019 - 12.2019
  • Performed the same tasks as listed above
  • Accurately filled prescriptions using Kroll System

Summer Research Studentship

Mount Sinai Hospital
04.2018 - 08.2018
  • Conducted a comprehensive literature review of 100+ articles on cricoid pressure and associated adverse events to support a meta-analysis.
  • Communicated study details to patients pre-surgery, ensuring informed understanding and consent.
  • Collected and recorded data on the accuracy of cricoid pressure application during surgery, including video documentation of tracheal intubation.
  • Collaborated in manuscript preparation; contributed to research published in BMC Anesthesiology.

Summer Research Studentship

St. Michael's Hospital
04.2017 - 08.2017
  • Project Name: Assessment of Patients with Thrombotic Complications after Tranexamic Acid Administration for Major Joint Arthroplasty
  • Analyzed 50+ patient records to identify thrombotic complications, contributing to a local conference presentation.
  • Developed data visualizations to clearly communicate study findings.
  • Maintained organized study documentation and records.
  • Conducted literature reviews to inform study design and stay current with research trends.

Education

Clinical Research Program, Ontario Graduate Certificate - Clinical Research

Humber College
08.2021

Bachelor of Science - Biological Sciences

University of Guelph
Guelph, Ontario
04.2019

Skills

  • Regulatory Compliance: GCP, FDA, IRB procedures
  • Patient Recruitment & Retention
  • Phlebotomy & Basic Laboratory Procedures
  • Data Management: EDC systems, accurate entry & verification
  • Clinical Trial Coordination: protocol adherence & monitoring
  • Strong Communication & Problem-Solving
  • Excellent Organization, Time Management & Attention to Detail
  • Knowledge of IATA Shipping Regulations
  • Team Player with Ability to Work Independently
  • Technical Proficiency: Clinical trial management systems, MS Office (Word, Excel, PowerPoint, Access, Outlook, OneNote)
  • Languages: English, Ukrainian, Russian

Certification

  • Clinical Research Graduate Certificate
  • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Course on Research Ethics (TCPS 2: CORE) Certificate
  • Health Canada Food and Drug Regulations Part C, Division 5: Drugs for Clinical Trials Involving Human Subjects Certificate (Version 4.0)
  • ICH Harmonized Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) Certificate (Version 5.0)
  • RFMH- A002a- The CSSRS Training Certificate
  • 2017 Keenan Research Summer Student Poster Competition Certificate
  • Completed training: TCPS2, Health Canada division 5 and GCP certificate, CPR certified, Smart Serve certified

Timeline

Parental Leave

Baby Boss (Self- Managed)
03.2022 - Current

Clinical Research Coordinator

DermEdge Clinical Research
03.2021 - 03.2022

Pharmacy Assistant

Dundas Kipling Pharmacy
01.2020 - 07.2020

Pharmacy Assistant

Pharmasave Westdale Mall
09.2019 - 12.2019

Summer Research Studentship

Mount Sinai Hospital
04.2018 - 08.2018

Summer Research Studentship

St. Michael's Hospital
04.2017 - 08.2017

Clinical Research Program, Ontario Graduate Certificate - Clinical Research

Humber College

Bachelor of Science - Biological Sciences

University of Guelph

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Khrystyna Gomenyuk