Profile Details

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Hire Shelby P.

United States

USD 25 /hr

Freelance Clinical Research Specialist with 5+ years of experience in clinical research

Profile Summary

I have 5+ years of clinical research experience as a Clinical Research Coordinator, Data Quality/Site Compliance Manager, and Safety Notification Specialist. I have worked in Academic Research, at a major Clinical Research Organization (CRO), and for a Sponsor (pharmaceutical company) directly. My diverse set of roles within a variety of types of clinical research companies have provided me with a well-rounded set of clinical research skills including the following. -SOP, CAPA, RCA development and implementation -Data Quality review, improvement, and assessment -IRB regulatory submission and maintenance -Protocol development and review -Protocol deviation identification and reporting/documenting -Best documentation practices, GCP, ALCOA-C+ -Adverse event identification, reporting, follow-up -etc.

Subject Matter Expertise

• ☆ Data Management
• ☆ Healthcare Quality Improvement
• ☆ Research Methodology
• ☆ Medical Writing

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Work Experience

Clinical Safety Notification Specialist

Astellas Pharma Inc.

June 2020 - Present

Site Compliance Manager

Accelerated Enrollment Solutions

February 2019 - May 2020

Research Project Coordinator

Northwestern University

April 2018 - February 2019

Clinical Research Coordinator

Midwest Orthopaedics at Rush

April 2016 - April 2018

Research Assistant

Knights of a Columbus Developmental Center

January 2015 - April 2016

Education

Master of Public Health

Saint Louis University

August 2014 - May 2016

Bachelor of Science

University of Illinois

August 2010 - May 2014

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Romeo, A.A., Thorsness, R.J., Sumner, S.A., Gobezie, R., Lederman, E.S., Denard, P.J.(2018). Short-term clinical outcome of an anatomic short-stem humeral component in total shoulder arthroplasty . Journal of Shoulder and Elbow Surgery. 27. (1). p. 70-74.

Frank, R.M., Romeo, A.A., Richardson, C., Sumner, S., Verma, N.N., Cole, B.J., Nicholson, G.P., Provencher, M.T.(2018). Outcomes of Latarjet Versus Distal Tibia Allograft for Anterior Shoulder Instability Repair: A Matched Cohort Analysis . American Journal of Sports Medicine. 46. (5). p. 1030-1038.

Savin, D.D., Frank, R.M., Sumner, S., Richardson, C., Nicholson, G.P., Romeo, A.A.(2018). Good functional outcomes expected after shoulder arthroplasty irrespective of body mass index . Journal of Shoulder and Elbow Surgery. 27. (6). p. S43-S49.

Riff, A.J., Frank, R.M., Sumner, S., Friel, N., Bach, B.R., Verma, N.N., Romeo, A.A.(2017). Trends in Shoulder Stabilization Techniques Used in the United States Based on a Large Private-Payer Database . Orthopaedic Journal of Sports Medicine. 5. (12).