Summary
Overview
Work History
Education
Skills
Websites
Organizations
Certification
Timeline
Generic

Hughette Watson

Chicago,IL

Summary

Qualified Regulatory Coordinator with 5 years of experience overseeing regulatory compliance including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines. Highly effective at aiding development of regulatory strategies, submitting applications in multiple study areas including hematology, breast, gastroenterology, and genitourinary (phase I, II, III). Successful at working collaboratively with cross-functional internal departments as well as external contacts . Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Regulatory Coordinator/ Oncology

Northwestern University
Chicago, IL
03.2022 - 03.2024
  • Coordinates and implements all study specific documents for multiple studies in accordance with the Institutional Review Board (IRB), Standard Operating Procedures (SOP) and study specific protocols and processes
  • Successfully prepared Institutional Review Board (IRB) applications to open and maintain regulatory documentation for pharmaceutical companies and cooperative groups such as Alliance, NRG, RTOG, CTSU, Advarra, WCG, and Investigator Initiated studies.
  • Close or terminate studies once the study has been completed
  • Cultivated strong relationships with study sponsors and regulatory personnel, guaranteeing that studies were conducted in accordance with the Code of Federal Regulations
  • Managed the study trial delegation of authority log, regularly incorporating any amendments
  • Efficiently oversaw management of regulatory documents, encompassing IRB approvals and sponsor memos in both electronic (Complion system) and paper binder formats.

Regulatory Coordinator/ Oncology

Northwestern University VIA Actalent
09.2021 - 03.2022
  • Evaluated appropriate documents and prepared required paperwork, including protocols and informed consent forms.
  • Verifies the correctness of IRB approval letters by ensuring accurate representation of sponsor information and correct identification of NIH grant identifiers.
  • Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
  • Created reports, summaries, and analysis to identify compliance requirements and suggested practice or procedure changes for enhanced compliance effectiveness and efficiency
  • Continuously updated knowledge of rules and regulations in conducting clinical trials with human subjects
  • Ensures seamless integration of changes into ongoing studies and trials by coordinating with relevant personnel.
  • Facilitated effective collaboration between research team members (PIs, faculty), healthcare professionals (nurses), technical staff (technicians), regulatory authorities at different levels (NIH sponsors, government agencies like FDA), by providing alternative options and recommendations tailored to expedite research processes in compliance with rules.

Research Coordinator

NorthShore University HealthSystem
04.2019 - 09.2021
  • Ensures adherence to regulatory guidelines in conducting clinical trials and research.
  • Maintained a well-organized system for storing and retrieving study materials such as regulatory binders, source documents, and correspondence.
  • Prepared and assisted in the development of new projects(study start-up) including submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.
  • Responsible for preparing accurate reports on relevant data and requirement statuses to be presented to investigators and sponsors. Additionally maintains regulatory documents for all study personnel including curriculum vitae, licenses, bio sketches and form FDA 1572. Manages tasks such as close out visits as well as delegation of duties logs.
  • Excellent regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines.
  • Collaborates with departmental staff and facility to develop and complete necessary documentation for continuing renewals, modification, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports.
  • Demonstrates a working knowledge of internal SOP's FDA/ICH guidelines to GCP'S and regulatory compliance.
  • Oversee reporting of AEs, SAEs, IND safety data, violations, deviations, and submission of other study documents to support regulatory compliance and troubleshoot processes and procedures when issues are identified.
  • Conducts site qualifications, study initiation, monitoring and or close out visits.

Education

Bachelor of Liberal Studies -

Roosevelt University
05.2015

Skills

  • MS Office (Outlook, Word, Excel, Power-Point)
  • Knowledge of regulatory policy and procedures
  • Attention to detail and excellent organizational skills
  • Medication Management
  • Medical terminology
  • Clinical Research
  • Clinical Trial

Organizations

  • Black Women in Clinical Research
  • Latinos in Clinical Research

Certification

  • Human Subjects Research (HSR)
  • Human Research/ Biomedical Research
  • Good Clinical Practice (GCP)
  • Essential of Research Administration (ERA)

Timeline

Regulatory Coordinator/ Oncology

Northwestern University
03.2022 - 03.2024

Regulatory Coordinator/ Oncology

Northwestern University VIA Actalent
09.2021 - 03.2022

Research Coordinator

NorthShore University HealthSystem
04.2019 - 09.2021

Bachelor of Liberal Studies -

Roosevelt University

Similar Profiles

CREATE PROFILE
Hughette Watson