Summary
Overview
Work History
Education
Skills
Certification
Interests
Accomplishments
Timeline
Generic

THAIS STOICOW

Clinical Trial Assistant
Kennesaw,GA

Summary

Dedicated professional with a robust background in clinical research, including 8 years of experience in diagnostics of infectious diseases, medical device and drug clinical trials across phases I-III. Expertise in trial coordination, compliance, and managing complex research operations, with a strong focus on stakeholder collaboration and achieving successful outcomes. Recognized for a strong work ethic, exceptional decision-making, and attention to detail. Committed to applying a diverse skill set to drive efficiency and contribute to advancing clinical research initiatives.

Overview

9
9
years of professional experience
1
1
Certification
5
5
Languages

Work History

Office Manager

Infinity Stone
04.2024 - 09.2024
  • Established and optimized e-commerce platforms, enhancing customer engagement and increasing sales.
  • Streamlined office operations and processes, improving productivity through an efficient filing system and managing supply requisitions.
  • Managed vendor relationships, negotiating contracts and ensuring on-time delivery, which improved supply chain efficiency.
  • Developed and maintained record management protocols to ensure efficient retention and disposal of records.
  • Managed office inventory, ensuring optimal stock levels and timely order placement.
  • Improved internal communication by serving as the primary contact for information sharing within the organization.

Clinical Research Associate/Jr Project Manager

Oxford Immunotec
03.2018 - 07.2022
  • Conducted site feasibility assessments, ensuring appropriate site selection aligned with trial objectives.
  • Oversaw the organization and submission of Clinical SOPs and fully executed CDA requests to maintain study integrity.
  • Collaborated with R&D and Legal to write, review, and edit study protocols and finalize contracts, ensuring compliance and operational efficiency.
  • Conducted site initiation visits (SIV), training investigators and site staff on CRF/eCRF completion, informed consent processes, and protocol requirements, including retraining after protocol violations.
  • Performed interim monitoring visits (IMV), remote monitoring visits (RMV), and close-out visits (COV), documenting findings in monitoring reports and ensuring adherence to ICH-GCP, 21CFR812, 21CFR50, study protocols, and internal SOPs.
  • Followed up with sites, collaborating closely to resolve queries and implement corrective actions identified during monitoring to ensure compliance and trial efficiency.
  • Created and maintained project-specific tools, including spreadsheets and comprehensive reports, to streamline trial management and data handling.
  • Preserved and audited the TMF/eTMF quarterly, ensuring complete, accurate, and compliant records with regulatory standards.
  • Managed relationships with vendors and supported site teams to address issues and ensure alignment with study objectives.
  • Developed and delivered PowerPoint presentations for SIVs, COVs, and site staff training, including retraining after protocol violations, to ensure compliance with study protocols, regulatory requirements, CRF/eCRF completion, and informed consent processes.

In-House Clinical Research Associate

Frenova Renal Research (FMC)
03.2017 - 11.2017
  • Supported clinical research studies by ensuring IRB approval and compliance with GCP and FDA regulations.
  • Collected and maintained essential regulatory documentation for assigned projects with precision.
  • Managed and maintained the Trial Master File (TMF/eTMF) ensuring document accuracy, completeness, and regulatory compliance. Ensured TMF/eTMF readiness for FDA inspections following defined protocols.
  • Verified investigator compliance with approved protocols, ICF customization, and GCP procedures on an ongoing basis.
  • Ensured all research activities received necessary IRB approvals and were aligned with regulatory requirements.
  • Monitored and ensured SAE reporting to the IRB in accordance with study protocol and FDA regulations.
  • Collaborated with Sponsors to distribute IND safety reports and alerts to sites and the CRO.
  • Served as the communication and document control liaison for trial activities, building strong working relationships with stakeholders.
  • Established and maintained relationships with sponsors and sites, acting as the primary in-house liaison for site management.
  • Supported preparation for on-site regulatory agency inspections and sponsor audits, ensuring compliance with all industry standards.

Clinical Trial Associate

Frenova Renal Research (FMC)
03.2016 - 08.2016
  • Tracked and monitored study activities using an EMR system (eCube) and a CTMS (Clinical Conductor), ensuring accurate documentation, progress tracking against study timelines, and maintaining department logs to monitor metrics and ongoing study developments.
  • Procured and maintained regulatory documents from study sites, ensuring compliance with regulatory standards and facilitating timely submissions for IRBs, study sponsors, and field staff, while managing licensure and regulatory updates.
  • Supported internal audits and prepared for quarterly and annual regulatory audits, ensuring compliance with study protocols, industry regulations, and applicable standards.
  • Coordinated communication across multiple stakeholders, including IRBs, study sponsors, field staff, and physicians, ensuring efficient information exchange and issue resolution throughout the study lifecycle.
  • Assisted with contracting processes and document preparation, ensuring proper contract management and the alignment of agreements with study objectives and legal requirements.
  • Managed clinical trial agreement payments and tracked financial records to ensure budget compliance and on-time payment processing.
  • Provided general support for research projects, assisting under Managerial and Director guidance, and reinforcing FMC culture by adhering to customer service standards and core values.
  • Efficiently handled general administrative tasks, including phone and fax operations, presentation preparation, and contributing to overall study operations

Administrative Assistant

Covidien/Medtronic
08.2015 - 03.2016
  • Optimized workflows across Clinical, R&D, Manufacturing, and Quality departments, encompassing meetings, schedules, and collaborative projects.
  • Oversaw office supplies, financial transactions, and invoice processing to guarantee resource availability and precision.
  • Facilitated shipping, receiving, internal communication, and Workplace Safety Inspections to ensure seamless operations.
  • Coordinated and replenished kitchens, managed shared data, and aided in company relocation for a seamless transition.

Education

Associate of Science - Criminal Justice

Strayer University
Miami, FL

Criminal Justice -

Middlesex Community College
Burlington, MA

Skills

  • Site Monitoring

  • Project Management

  • Vendor Management

  • Clinical Data Management

  • Regulatory Compliance Management

  • Audit and Quality Control

  • SOP Development

  • OpenClinica

  • Clinical Conductor

  • eCube

  • SharePoint

  • Salesforce

  • Adobe Pro

MS Office

Certification

Barnett International Certifications

Interests

Sourdough enthusiast

Plant lover

Travel

Fitness

Health and Wellness Research

Autism Advocacy

Content Creation for English Learners

Accomplishments

Increased Company Growth through E-commerce Initiatives

Infinity Stone

Developed and sustained the company's online e-commerce platforms to enhance customer engagement, resulting in significant sales growth and a stronger position in the market.


Lead Clinical Associate Role

Oxford Immunotec

Managed and organized the entire clinical trial processes, ensuring compliance with regulations and smooth operations, which was crucial for achieving successful trial completions.

Ensured all site files were meticulously organized and fully compliant in preparation for an FDA audit as a new hire. Dedicated additional hours, including weekends, to guarantee audit readiness, resulting in a highly successful audit outcome.


Regulatory Compliance Leadership

Frenova Renal Research

A leader in regulatory compliance, ensuring exemplary standards for documentation and TMF/eTMF management throughout clinical trials.

Timeline

Office Manager

Infinity Stone
04.2024 - 09.2024

Clinical Research Associate/Jr Project Manager

Oxford Immunotec
03.2018 - 07.2022

In-House Clinical Research Associate

Frenova Renal Research (FMC)
03.2017 - 11.2017

Clinical Trial Associate

Frenova Renal Research (FMC)
03.2016 - 08.2016

Administrative Assistant

Covidien/Medtronic
08.2015 - 03.2016

Associate of Science - Criminal Justice

Strayer University

Criminal Justice -

Middlesex Community College

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THAIS STOICOWClinical Trial Assistant