Summary
Overview
Work history
Education
Skills
Certification
Timeline
Generic

Paige Wolfe

Wilburton,CAM

Summary

A highly motivated and customer-focused Safety Reporting Coordinator within the Filing Team, with two years of experience in the clinical research and pharmaceutical industry. I have demonstrated a comprehensive understanding of Study Close-Out, Audit, and File Return processes, encompassing all study protocols. My expertise includes research development, protocol development, complete submissions, and study close-out activities across North America, Asia Pacific, and Europe.

Offering strong organisational skills and keen ability to manage multiple tasks in fast-paced environments. Knowledgeable about coordinating schedules, communicating clearly, and solving problems quickly. Ready to use and develop skills in time management, teamwork, and communication in my role.

Overview

8
8
years of professional experience
1
1
Certification

Work history

Safety Reporting Coordinator

Thermo Fisher
Hybrid, CAM
03.2023 - Current
  • Assumes responsibility for receiving and preparing study close-out notifications to applicable parties, ensuring compliance with regulatory timelines and country-specific legislations.
  • Demonstrates a thorough understanding of Standard Operating Procedures (SOPs), Guidance Documents (GDs), and project-related documentation.
  • Provides regular updates to clients and the filing team regarding each protocol.
  • Facilitates effective communication with the audit and filing return teams, including sharing ideas and suggestions to enhance productivity.
  • Manages the retrieval of hard copy files and prepares them for dispatch to the client's specified address.
  • Resolves issues in accordance with Operating Procedures and Guidance Documents.
  • Maintains ongoing communication throughout the entire return process of protocol files with relevant parties.
    Lead for Moderna and Audit Readiness
  • Oversees and coordinates all activities related to audit readiness and compliance for Moderna projects, ensuring alignment with regulatory standards.
  • Leads efforts to maintain high standards in quality control, file returns, file reviews, manual filing, and web-portal filing.
  • Conducts training sessions for team members on best practices and regulatory compliance.
  • Implements process improvements and technology integrations to enhance efficiency and accuracy in audit readiness and file management.

Warehouse Operative

Unipart Logistics
Bury St Edmunds , Suffolk
07.2021 - 03.2023
  • Picked, packed and dispatched high-volume orders, consistently exceeding warehouse performance targets.
  • Attended Health and Safety training to ensure consistent adherence to warehouse safety policies.
  • Maintained high levels of cleanliness in working
  • areas, meeting compliance standards for health, safety and hygiene regulations.
  • Reported issues and damages to senior warehouse staff, enabling prompt, effective resolutions.
  • Operated forklifts to lift and move heavy cargo to designated areas.
  • Assisted Administration to help set up the shift and maintain help from the desk to ensure stock and colleagues ran smoothly.

Mc Donald's

Crew trainer
Barton Mills, Suffolk
04.2019 - 07.2021
  • Cooked and prepared foods and monitored food production according to quality and sanitation standards.
  • Greeted customers promptly and took orders to keep flow of traffic moving.
  • Reduced customer wait times by quickly operating customer window and sales register.
  • Followed food safety procedures outlined in company policies and health and sanitation regulations to prevent food borne illness.
  • Performed shift change tasks each day to keep store neat and running smoothly.
  • Cleaned counter surfaces, dining areas and food preparation areas for maximum health, safety and customer satisfaction.
  • Promptly resolved customer complaints, escalating major issues to supervisor.

Staff Member

BX (RAF Lakenheath)
Lakenheath , Suffolk
03.2017 - 04.2019
  • Increased customer satisfaction by greeting visitors promptly and professionally.
  • Assessed client satisfaction and communicated issues to organisational leaders.
  • Standardised department filing system to increase efficiency.
  • Handling food products
  • Maintained reception area in orderly manner to provide visitors with positive first impression of company.

Education

High School Diploma - Travel And Tourism

West Suffolk College
Bury St Edmunds, Suffolk
07.2019

High School Diploma - Mathematics

Mildenhall College Academy
Mildenhall, Suffolk
06.2017

High School Diploma - English

Mildenhall College Academy
Mildenhall, Suffolk
06.2017

High School Diploma - BCS Level 2 ECDL in IT Application Skills

Mildenhall College Academy
Mildenhall
06.2017

Skills

  • Clinical Research and Pharmaceutical Industry Experience
  • Study Close-Out and Audit Processes
  • Organizational and Time Management
  • Regulatory and Compliance Knowledge
  • Client Communication and Issue Resolution
  • Audit Readiness and Quality Control
  • Process Improvement and Technology Integration
  • Warehouse Operations and Safety Compliance
  • Customer Service and Satisfaction
  • Administrative and Filing System Management
  • Food Safety and Hygiene Compliance

Certification

  • Licensed mental health first aider - 2022-2025
  • Health and Safety Rep ongoing education- 30/1/23

Timeline

Safety Reporting Coordinator

Thermo Fisher
03.2023 - Current

Warehouse Operative

Unipart Logistics
07.2021 - 03.2023

Mc Donald's

Crew trainer
04.2019 - 07.2021

Staff Member

BX (RAF Lakenheath)
03.2017 - 04.2019

High School Diploma - BCS Level 2 ECDL in IT Application Skills

Mildenhall College Academy

High School Diploma - Travel And Tourism

West Suffolk College

High School Diploma - Mathematics

Mildenhall College Academy

High School Diploma - English

Mildenhall College Academy

Similar Profiles

Create profile
Paige Wolfe