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Regulatory Submissions Coordinator

Location:
Maineville, Ohio, United States
Salary:
60,000
Posted:
October 17, 2018

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Resume:

KATELIN STAPLETON

**** ********** ****** **********, ** 45039 513-***-****

ac7e08@r.postjobfree.com Katelin (Henninger) Stapleton

Graduate of Kettering College with a Bachelor's degree in pre-med with an interest in medical research. Recognized by employers for initiative, attention to detail and strict adherence to company policies. Ease and success and dependability in team environments. Experience and skill in multiple laboratory techniques.

EXPERIENCE

FEBRUARY 2018 – PRESENT

REGULATORY SUBMISSIONS COORDINATOR, Medpace

Distribute, track, review, and approve individual site trial master file (TMF) essential documentation at project start

Collect, review, organize, and assemble regulatory submissions

Maintain timelines for study start-up submissions and all subsequent submissions

Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements

Review pertinent regulations and guides to develop proactive solutions to clinical trial submissions issues and challenges

Collaborate with document center to ensure necessary documentation is present

Train and assist CRAs on the collection of essential documentation for the ongoing phase of the project

DECEMBER 2016 – FEBRUARY 2018

STYLIST, Davids Bridal

Provide customer service for brides, attendants, and family members

APRIL 2014 – JANUARY 2018

UNIVERSAL CARE WORKER, Legacy Village

Provided daily personal care and transportation of residents in the assisted living and the Memory Care Units of the facility

AUGUST 2014 – JULY 2017

TUTOR, Kettering COllege

Broke down complex problems to individual learning levels

Helped students build continuously increasing knowledge

Held group and one-on-one tutoring sessions

Tutored a wide range of mathematics and science courses

JULY 2016 – DECEMBER 2016

DELEGATED NURSE/IN-HOME CAREGIVER, Residential community care

Administered prescriptions medicine and provided transportation, meal preparation, personal care, household maintenance, and overnight care for MRDD patients

EDUCATION

APRIL 2017

BACHELOR OF SCIENCE IN HUMAN BIOLOGY (PRE-MED), Kettering College

Graduated magna cum lade with honors

SKILLS

Microsoft Office

Laboratory techniques/skills: animal specimen dissections, DNA extraction, titrations, cultures, cadaver lab, gel electrophoresis (western blot)

First Aid and CPR certificate, American Safety & Health Institute

ACTIVITIES

Volunteer Work:

Truth for Today Medical Missions

Medical assistant August 2015-David, Panama

oDetermine vitals on every patient in the clinic

oPatient liaison

Leadership opportunities:

Greene County 4-H

Exhibitor January 2005-August 2015

oAnimal husbandry, caretaking, and exhibition

oAmbassador, public speaking

oGoal-setting and implementation



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