Summary
Overview
Work History
Education
Skills
computer software skills
relevant coursework projects
Timeline
Generic

KATHRYN SULLIVAN

Charlotte,NC

Summary

Hardworking Clinical Research Associate with 2 years of experience performing regulatory document collection, source data verification/review, and interim monitoring visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.

Overview

8
8
years of professional experience

Work History

Clinical Research Associate

PPD
01.2022 - Current
  • Performs and coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
  • Conducts site visits to determine protocol and regulatory compliance and prepares required documentation
  • Develops collaborative relationships with investigative sites and client company personnel.

Clinical Trial Coordinator

PPD
08.2020 - 01.2022
  • Provides clinical support for the clinical team through tracking and filing regulatory documents and ensured all documents met ALCOA guidelines for a Phase III randomized, stratified, observer-blind, placebo-controlled Vaccine trial in adult subjects
  • Leads a SWAT team of 12 people through audit preparation and reconciliation of 100 sites for a high-profile study
  • Trains new team members on effective document tracking/filing, provides them with support, and ensures they are familiar with all programs used daily
  • Won CEO Defining Principles "Will to Win" award in January of 2021 for keeping up with the fast moving pace of a well-known study.

Recruiting Assistant

Experis
09.2019 - 08.2020
  • Provides SAP Fieldglass support including submitting candidates and funneling interview details to recruiters
  • Forms and maintains close relationships with the Fieldglass representatives for the company's top enterprise account
  • Effectively provides data analysis of candidate profiles.

iScribes Medical Scribe

iScribes Inc.
08.2017 - 05.2019
  • Responsible for listening to physician patient encounters and efficiently completing medical charts for patients
  • Works closely with physicians, documenting electronic medical recordings
  • Updates and maintains medical history, assessment and planning, findings and procedures for medical patients.

Physical Therapy and Occupational Therapy Volunteer

UNC Health Care Hospital System
08.2016 - 05.2019
  • Volunteered on the rehabilitation floor and unit at the UNC Rehabilitation Center, assisting physical therapists and occupational therapists
  • Volunteered at the Burn Center answering phone calls, delivering food and beverages to patients, and ordering out-of-stock products.

Campus Recreation Marketing and Promotions Specialist

UNC Chapel Hill
06.2017 - 01.2018
  • Responsible for effectively promoting UNC Chapel Hill Campus Recreation to incoming students via on-campus events and trade booths
  • Developed and facilitated information sessions during freshman and transfer orientation
  • Educated students about making a commitment to a healthy and active lifestyle through various campus recreational programs such as intramural sports, fitness classes, and sporting clubs.

Education

Bachelor of Arts - Exercise And Sport Science

University of North Carolina At Chapel Hill
Chapel Hill, NC
05.2019

Skills

  • Electronic Data Compliance (InForm, Medidata Rave)
  • eTMF Systems (Veeva Vault)
  • CTMS Systems
  • Protocol Adherence
  • Patient Safety
  • Site Monitoring
  • Clinical Documentation
  • Quality Assurance

computer software skills

  • CTMS
  • VeevaVault
  • InForm (EDC)
  • SBIR
  • GoBalto
  • Microsoft Office Suite - (Word, Powerpoint, Excel, Outlook, Access, Publisher, SharePoint, OneDrive, OneNote)
  • Google Platform - (GMAIL, Google Calendars, Google Sheets, Google Docs)

relevant coursework projects

  • Human Anatomy
  • Physical Activity in Contemporary Society
  • Sport and Exercise Psychology
  • Research in Exercise and Sport Science
  • Human Physiology
  • Emergency Care of Athletic Injuries and Illnesses
  • Physiological Basis of Human Performance
  • Neuromuscular Control and Learning
  • Biomechanics of Sport
  • Biology
  • Chemistry
  • Mock Research Project: "Stimulants: Are Athletes Likely to be Prescribed Stimulants Before Entering College or During College?"

Timeline

Clinical Research Associate

PPD
01.2022 - Current

Clinical Trial Coordinator

PPD
08.2020 - 01.2022

Recruiting Assistant

Experis
09.2019 - 08.2020

iScribes Medical Scribe

iScribes Inc.
08.2017 - 05.2019

Campus Recreation Marketing and Promotions Specialist

UNC Chapel Hill
06.2017 - 01.2018

Physical Therapy and Occupational Therapy Volunteer

UNC Health Care Hospital System
08.2016 - 05.2019

Bachelor of Arts - Exercise And Sport Science

University of North Carolina At Chapel Hill

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