Summary
Overview
Work History
Education
Skills
Timeline
Generic

Kelly Duddy, CRA

Summary

To leverage my comprehensive experience in clinical research operations and regulatory compliance as a dedicated Global Trial Specialist, contributing to high-impact projects at Bristol Myers Squibb through meticulous study management and cross-functional collaboration.

Overview

9
9
years of professional experience

Work History

CRA - Site Monitor

Syneos Health
05.2024 - Current
  • Managed clinical trial activities to ensure adherence to protocols and regulatory requirements.
  • Reviewed subject diaries for compliance, severe reactions, and symptom resolution.
  • Monitored study progress, resolved issues, and ensured data accuracy.
  • Collaborated with investigators, site staff, and sponsors to maintain effective communication and project timelines.
  • Reviewed and analyzed clinical data, prepared reports, and contributed to study documentation.
  • Ensured adherence to Good Clinical Practice (GCP) guidelines and company SOPs.
  • Implemented corrective actions and risk mitigation strategies to address study challenges.

CMA II - Clinical Monitoring

Syneos Health
09.2023 - 05.2024
  • Reviewed and resolved issues and actions, protocol deviations, and data queries.
  • Collected Investigator signature pages, submitted documents to TMF, reconciled TMF documents, and assisted study staff with systems access requests and updates.
  • Supported audit preparation for a high-level program, including reviewing SSDDL, trainings, and supporting documents.
  • Reviewed out-of-window monitoring visits to ensure proper documentation is in place.

Senior Global Trial Specialist

Syneos Health, FSP - Bristol Myers Squibb
08.2020 - 09.2023
  • Supported in-house organization, management, and execution of global clinical research projects in compliance with protocols, regulations, SOPs, GCPs, and ICH Guidelines.
  • Managed Trial Master File (TMF), conducted quality reviews, and facilitated Investigator Eligibility Review Process as Subject Matter Expert (SME).
  • Utilized Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Electronic Data Capture (EDC) systems, and contributed to Investigational Product (IP) reconciliation.
  • Reviewed monitoring visit reports for data quality and safety event reporting compliance.
  • Spearheaded initiatives such as new hire onboarding packets and a podcasting program to enhance site education on clinical trial program aspects.
  • Assumed responsibilities in the absence of Global Trial Manager (GTM), including cost approvals, CRO CRA capability assessments, and oversight of out-of-scope tasks.

Registered Dental Hygienist

Joseph Derario, DMD & Ariane Seto DMD, LLC
02.2017 - 08.2020
  • Managed the dental hygiene department and served as the primary point of contact.
  • Conducted clinical screenings and performed procedures.
  • Oversaw supply inventory management and maintained expense reports.
  • Directed office marketing and promotional activities, including newsletters and community outreach.
  • Developed a periodontal program to enhance patient care standards.
  • Ensured accuracy of medical and dental records through meticulous documentation of patient data.

Registered Dental Hygienist

Dental Fillings, Inc
07.2015 - 08.2020
  • Quickly adapted to new office environments, equipment, and team members as a temporary dental hygienist.
  • Earned trust from dental patients as a new team member.
  • Became a highly requested hygienist within the agency by building strong rapport with dental offices.

Registered Dental Hygienist

Valerie Barba, DDS, LLC
07.2015 - 02.2017
  • Utilized assessment data and clinical expertise to deliver tailored treatment and optimal standard of care to every patient.
  • Demonstrated responsibility and accountability for professional practice, conduct, and decision-making in clinical settings.

Education

IAOCR Accredited, CRA

Syneos Health Clinical Training Institute (CTI)
Morrisville, NC
2023

A.A.S. - Dental Hygiene

Middlesex College
Edison, NJ
2015

B.A. - Contemporary Arts - Design

Ramapo College of New Jersey
Mahwah, NJ
2009

A.S. - Biology

Ocean County College
Toms River, NJ
2007

Skills

  • Clinical Research Experience: Proven track record in global clinical research, ensuring adherence to protocols, regulations, and GCP
  • Project Management: Successfully managed study timelines, plans, and documents, ensuring on-time project delivery
  • Regulatory Compliance: Knowledge of ICH/GCP guidelines, adept at developing and submitting regulatory documents
  • Technical Proficiency: Expertise in CTMS, IRT, EDC systems, and MS Office for reporting and documentation
  • Team Collaboration: Effective collaboration with cross-functional teams and stakeholders to achieve study objectives
  • Problem Solving and Risk Management: Skilled in identifying issues, developing solutions, and managing risks for smooth study execution
  • Communication Skills: Strong oral and written communication, adept at coordinating meetings and presenting findings
  • Vendor Management: Experience overseeing CRO systems/vendors, including selection, oversight, and payment tracking
  • Quality Assurance: Conducted quality reviews, managed TMF, and ensured compliance with SOPs and quality systems
  • Adaptability and Initiative: Ability to adapt to changing demands, drive process enhancements, and contribute to team and corporate goals

Timeline

CRA - Site Monitor

Syneos Health
05.2024 - Current

CMA II - Clinical Monitoring

Syneos Health
09.2023 - 05.2024

Senior Global Trial Specialist

Syneos Health, FSP - Bristol Myers Squibb
08.2020 - 09.2023

Registered Dental Hygienist

Joseph Derario, DMD & Ariane Seto DMD, LLC
02.2017 - 08.2020

Registered Dental Hygienist

Dental Fillings, Inc
07.2015 - 08.2020

Registered Dental Hygienist

Valerie Barba, DDS, LLC
07.2015 - 02.2017

IAOCR Accredited, CRA

Syneos Health Clinical Training Institute (CTI)

A.A.S. - Dental Hygiene

Middlesex College

B.A. - Contemporary Arts - Design

Ramapo College of New Jersey

A.S. - Biology

Ocean County College

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Kelly Duddy, CRA