Summary
Overview
Work History
Education
Skills
Publications
Timeline
Generic

Carly Guzzardo

Phoenixville,PA

Summary

Results-driven Clinical Trial Associate with a solid foundation in clinical research and study coordination. Demonstrates exceptional communication and problem-solving skills to facilitate successful trial outcomes through effective collaboration. Proven ability to meticulously adhere to protocol requirements, ensuring compliance and enhancing study efficiency. Committed to continuous professional growth in the field of clinical research.

Overview

5
5
years of professional experience

Work History

Clinical Trial Associate

KPS Life
Malvern, PA
08.2023 - Current
  • Supports study team in ensuring successful execution of clinical trials from conception to close-out.
  • Maintains the Trial Master File (TMF) and makes requests for outstanding documents when necessary. Regularly performs TMF quality reviews to ensure completeness, and inspection readiness.
  • Creates and maintains study tracking tools for feasibility and site selection, study supplies, system accesses, regulatory documents, and debarment checks.
  • Assists with submissions to the IRB/IEC.
  • Contributes to the development of study documents and provides feedback.
  • Oversees the preparation, tracking, and handling of study supply shipments and returns. Coordinates with CROs, vendors, and sites to ensure the timely delivery of essential study supplies, resolves any issues, enhances study efficiency, and improves vendor and site relations.
  • Works directly with site personnel and ensures effective communication between sites and the study team. Schedules, prepares, and participates in the study meetings, including internal team members, vendors, risk assessment, investigators, and CRAs.
  • Participates in the monthly review of data listings and protocol deviations, and attends meetings.
  • Handles access requests and revocations for various systems. Conducts periodic reviews of system accesses.
  • Assigns protocol-specific trainings for study team.
  • Analyzes eCOA, EDC, and IRT data weekly, supporting the primary endpoint and driving process improvements.
  • Works directly with the sites and CRAs, and escalates to the Clinical Trial Manager, when necessary.
  • Collaborates with internal team, CROs, vendors, CRAs, and sites to enhance study efficiency.
  • Demonstrates proficiency in ICH-GCP guidelines, regulations and applicable SOPs for clinical trials.

Site Management Associate

ICON Clinical Research
Blue Bell, PA
10.2021 - 07.2023
  • Assisted in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating and reviewing responses to site recruitment questionnaires.
  • Completed essential document collection and review throughout the study lifecycle inclusive of site activation. Organized and maintained site clinical Trial Master File (TMF) documents.
  • Set up and maintained site-related data in applicable clinical systems according to procedures and guidelines.
  • Acted as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting off-site central monitoring visits/contacts (pre-study, initiation, monitoring and close-out visits). Escalates issues and risks as needed.
  • Ensured timely and complete data entry by site. Performed data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
  • Performed risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow-up items and issue escalation.
  • Performed all tasks in accordance with applicable guidelines (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, and local regulatory requirements.
  • Completed notifications to regulatory authorities, ethics committees, and other bodies.
  • Performs and documents clinical data review, query creation, query resolution, offsite central monitoring contacts/visits, and site management communications, as outlined in the study plans (and/or other processes).).
  • Set up and maintained study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems, according to project protocol, applicable SOPs and project plans.

Project Associate

ICON Clinical Research
Blue Bell, PA
09.2020 - 09.2021
  • Managed internal and client project reporting. Generated and reviewed for accuracy reports to facilitate project status and financial reporting. Completed system updates and queries.
  • Supported Project Manager with financial tasks. Had oversight of purchase order process including creating and processing purchase orders and processing study invoices. Processed investigator payments.
  • Organized study information and supplies. Generated and maintained organizational charts, team calendar, newsletters, mass mailings, project specific information including but not limited to process flow charts, contact lists, holiday lists, study website, and mailing labels. Tracked, dispatched and maintained study supplies following applicable company processes.
  • Used the Learning Management System to assign project-specific training to team members and tracked training compliance.
  • Supported preparation of study files by maintaining and distributing project documents. Ensured documents within the electronic master file comply with filing/naming guidelines and have the correct status.
  • Organized project team and client meetings including scheduling, meeting materials, binders, agendas and meeting minutes.

Education

Master of Public Health - Environmental Health

West Chester University of Pennsylvania
West Chester, PA
08.2020

Bachelor of Science - Public Health

Temple University
Philadelphia, PA
08.2018

Skills

  • Knowledge of clinical trial process, quality and data management, and clinical operations
  • Critical thinking and resourcefulness
  • Excellent oral and written communication skills, including CRO, vendor, and site relationships
  • Problem Resolution
  • Organizational and time management skills
  • Strong attention to detail
  • Computer/System Skills, including Microsoft Office, Clinical Trial Management System (CTMS), Interactive Response Technology (IRT), Electronic Data Capture (EDC), and Trial Master File (TMF)

Publications

Carrieri, M.; Guzzardo, C.; Farcas, D.; Cena, L.G. Characterization of Silica Exposure during Manufacturing of Artificial Stone Countertops. Int. J. Environ. Res. Public Health 2020, 17, 4489.

Timeline

Clinical Trial Associate

KPS Life
08.2023 - Current

Site Management Associate

ICON Clinical Research
10.2021 - 07.2023

Project Associate

ICON Clinical Research
09.2020 - 09.2021

Master of Public Health - Environmental Health

West Chester University of Pennsylvania

Bachelor of Science - Public Health

Temple University

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