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Regulatory Affairs Associate/Paralegal

Memphis, TN

Elizabeth Starling
Memphis, TN | 910-583-4666 | Elizabethstarling93@gmail.com

Education

M.S. | DECEMBER 2018 | THE OHIO STATE UNIVERSITY
· Major: Applied Clinical and PreClinical Research
· Specialization: Regulatory Affairs
SUPPLEMENTAL EDUCATION PRE-MASTER’S | SPR/SUM 2017 | PAMLICO COMMUNITY COLLEGE
· Human Anatomy and Physiology I
· Chemistry I
· Medical Terminology I
B.A. | DECEMBER 2015 | NORTH CAROLINA STATE UNIVERSITY
· Major: Pre-Law
· Minor: Philosophy

Experience

ASSOCIATE REGULATORY AFFAIRS SPECIALIST | MEDTRONIC | DEC 2017-PRESENT
· Coordinating and preparing product documentation for international regulatory agencies
· Coordinating and consulting with other departments on the content, review and assembly of regulatory documentation
· Maintenance of electronic and physical regulatory archives for all products
· Computer database and software applications knowledge, strong communication skills, results oriented focus, the ability to work independently on multiple projects, and international regulatory medical device knowledge are also required
CUSTODY PARALEGAL | THE COUNCIL FOR CHILDREN’S RIGHTS | JUNE 2016-AUG 2017
· Provided direct support to five staff attorneys with duties such as: requesting various records from medical facilities, criminal institutions, schools, the Department of Social Services, etc., reviewing and understanding records, drafting documents, and filling documents.
· Further duties included attending Calendar Call and scheduling trials, which involved assigning volunteer attorneys and custody advocates, as well as maintaining the volunteer database.
INTAKE COORDINATOR | WAKE CO. PUBLIC DEFENDER’S OFFICE| NOV 2015-JUNE 2016
· Main tasks were assigning over 30 in-house and over 75 contract attorneys to all incoming cases.
· Conflict checking was crucial to avoid a conflict of interest between attorneys and other clients, and consisted of cross-checking co-defendants, victims, previous charges, etc.
· Other duties involved maintaining the attorneys’ schedules, caseloads, and the types of cases that they were taking.
· Database skills were necessary to use ACIS, the courthouse system, as well as several Excel spreadsheets.

Certificates and Training

MEDTRONIC LEAP MENTORSHIP PROGRAM| AUG 2018-APR 2018
· Mentorship program involving associate level and senior level Medtronic employees across various business functions fostering professional growth through active programming and company networking.
· Program concludes with an immersive, cross functional capstone project presented to the Memphis Executive Leadership Team.
CITI GOOD CLINICAL PRACTICE AND ICH | AWARDED AUG 2017
· Completed training program regarding good clinical practices for trials involving drugs and devices.
· The training program included modules on ICH; FDA regulations; informed consent, particularly with vulnerable subjects; detecting, evaluating, and reporting adverse events; and audits, inspections, and monitoring clinical trials.
CITI BIOMEDICAL HUMAN SUBJECTS RESEARCH | AWARDED AUG 2017
· Completed training program regarding biomedical human subjects research.
· The training program included modules on the history and ethics behind human subjects research, which led to the regulations that are in place today; basic IRB functions, regulations, and review process; the various types of human subject research; human subjects that require further protections beyond the standard level; HIPPA protections; and conflicts of interests involving human subjects.
PARALEGAL CERTIFICATE | AWARDED OCT 2015
· Completed an eight-teen week program, finishing in the top five percent, through North Carolina State University.
· Program work involved, but was not limited to the preparation of documents, response to ethical situations, litigation support, client communication, legal system structure, legal referencing, legal research, issue spotting, relevant fact practice, etc.

Professional Memberships

MEDTRONIC MEMPHIS YOUNG PROFESSIONALS| JULY 2018-PRESENT
SOCIETY OF CLINICAL RESEARCH ASSOCIATES| SEPT 2017-PRESENT
THE ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS| SEPT 2017-PRESENT

Skills and Abilities

CROSS-CULTURAL COMMUNICATION
· I have studied abroad in France, visited various European, Asian, and Caribbean countries, as well as have worked with colleagues that are in locations abroad, allowing me to develop advanced skills in cross-cultural communication.
MANAGEMENT
· While working in retail during my time in undergraduate school, I was quickly promoted to management roles that included scheduling, training, key holding, floor sets, executive meetings, etc.
STATISTICAL PACKAGE FOR THE SOCIAL SCIENCES
· I have proficient skills in SPSS that require the understanding and manipulation, organization, and assessment of variables from data sets to run analysis on the data at hand.
· Analysis may include regression analysis, data frequencies, graphing, etc.
· SPSS is useful for understanding and evaluating large data sets that are commonly surveys and other such similar information.
MICROSOFT OFFICE SUITE
· Proficient skills and knowledge in all areas of Microsoft Office Suite, and these skills are used daily.

Education

Aug2017-DEC2018

Master's in PreClinical and Clinical Research-Regulatory Affairs at The Ohio State University

Aug2018-DEC2015

Bachelor's in Pre-Law at North Carolina State University

  • Updated 2 years ago

To contact this candidate email elizabethstarling93@gmail.com

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