Summary
Overview
Work History
Education
Skills
Licenses Certificates
Therapeutic Experience And Expertise
References
Timeline
Generic
Lexi Bermudez

Lexi Bermudez

Fort Mill,USA

Summary

Versatile, customer-focused Principal Safety Committee Specialist within Pharmacovigilance and Drug Safety with more than 4 years in the clinical research and pharmaceutical industry. Her depth of experience in clinical research involves working as an adjudication safety committee specialist on a wide variety of studies in various therapeutic areas. She works adeptly in team environments and displays strong leadership abilities. Mrs. Bermudez holds a master’s degree in clinical research with a concentration in clinical research management from The Ohio State University and a bachelor’s degree in nursing from Western Carolina University. She is a compassionate Registered Nurse with extensive pediatric hematology/oncology/cellular therapies experience.

Overview

7
7
years of professional experience

Work History

Principal Safety Committee Specialist

PPD
Wilmington, NC
04.2021 - Current
  • Works independently providing expertise in overseeing oversee day to day CEC/DSMB activities.
  • Exercises independent judgement to troubleshoot and resolve project issues and identify areas for improvement.
  • Functions in a lead role. Serves as primary point of contact in the absence of the manager. Mentors less experienced staff.
  • Acts as primary study contact or lead with internal and/or external clients.
  • Initiates CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities.
  • Performs day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.
  • Reviews adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC and DSMB practices.
  • Maintains medical understanding of applicable therapeutic area and disease states.
  • Prepares and QCs CEC dossier compilation and submission.
  • Maintains secure files for DSMB unblinded data.
  • Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to specialty committee activities.
  • Participates in/leads departmental initiatives; serves as a subject matter expert in designated area, including business development.
  • May assist in the preparation and development of departmental and project[1]specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings representing the CEC and/or DSMB specialty committee functions.

Registered Nurse, Pediatric Oncology

Levine Children's Hospital
CHARLOTTE, USA
07.2018 - 04.2021
  • Held roles of Inpatient Nurse, Nurse Educator, and Patient Nurse Navigator
  • Managed 61 teammates educational requirements and activities
  • Provided/developed oncology and BMT specific education, SOPs and policies
  • Held chair on policy and procedure committee, unit-based council, best practice committee, and various quality improvement projects
  • Received multiple Values in Action awards and WOW awards.

Registered Nurse

Golisano Children's Hospital
FORT MYERS, USA
06.2017 - 07.2018
  • Provided inpatient nursing care involving both acute and chronic conditions
  • Spirit Award recipient for exceptional care.

Education

Master of Science - Clinical Research Management

The Ohio State University
Columbus, OH
08.2021

Bachelor of Science - Nursing

Western Carolina University
Cullowhee, NC
05.2017

Skills

  • Customer Relations
  • Quality Assurance
  • Organizational Skills
  • Good clinical practice
  • Study coordination
  • Standard Operating Procedures
  • Medidata Rave
  • Microsoft Office
  • eTMF management
  • Teamwork and Collaboration
  • Resource Allocation

Licenses Certificates

  • Registered Nurse, 2017
  • Association of Pediatric Hematology/Oncology Nurses- Chemotherapy Certification, 2018

Therapeutic Experience And Expertise

  • Leukemia
  • Lymphoma
  • Sickle Cell Disease
  • Aplastic Anemia
  • Bone Marrow Transplant
  • Cellular Therapies
  • Type 1 Diabetes
  • Infectious Disease (CMV/COVID)
  • Cardiomyopathy
  • Amyloidosis
  • Pulmonary Arterial Hypertension
  • COPD
  • Cystic Fibrosis
  • Asthma
  • Stroke
  • Rare Disease

References

References available upon request.

Timeline

Principal Safety Committee Specialist

PPD
04.2021 - Current

Registered Nurse, Pediatric Oncology

Levine Children's Hospital
07.2018 - 04.2021

Registered Nurse

Golisano Children's Hospital
06.2017 - 07.2018

Master of Science - Clinical Research Management

The Ohio State University

Bachelor of Science - Nursing

Western Carolina University

Similar Profiles

CREATE PROFILE
Lexi Bermudez