Health Clinical Research

Amanda Rudelt, MPH

**** ****** *** *, ***********, MN 55411 651-***-**** ******.******@*****.***

Objective

An opportunity to build on my clinical research coordination, regulatory affairs experience and utilize my epidemiology and

biostatistics training.

Education

Masters of Public Health August 2012 University of Minnesota, Minneapolis MN

Major: Epidemiology

Related coursework: Epidemiologic Methods (SAS), Biostatistical Inference(R),Biostat Modeling and Methods (R, SAS),

Public Health Policy Prevention Strategy, Decision Making in Public Health, Budgeting and Planning in Public Health, and

Nutrition

Bachelor of FIne Arts May 2000 Rochester Institute of Technology, Rochester NY

Major: Applied Photography

Related coursework: Advertising Photography, Photo Chemistry, Historic Photo Chemistry, Optics

Publication

Rudelt A, Harnack L, French S, 14-year Trends in Sodium Content of Menu Offerings at Eight Leading Fast Food

Restaurants in the U.S. Public Health Nutrition. Accepted 25 July 2013

Skills & Abilities

Communication and Writing

Master’s Thesis accepted for publication in peer reviewed journal.

Illustrated ability to explain complex study protocols, risks and benefits, and required elements of consent at 8 th grade reading

level.

Data Analysis

Trained in bio-statistical modeling and methods. Conducted analysis, model fitting, and interpretation in SAS, Stata, and R

environments.

Understanding of linear, logistical, hierarchical, and hazard models.

Broad understanding of study design.

Experience

Regulatory Affairs Associate Davita Clinical Research Via Baker Tilly June 2012-December 2012

Created regulatory documents for all sites ensuring they met sponsor and FDA Federal Code of Regulation requirements.

Coached and trained physicians new to research in obtaining IRB approval, developed 10 new research sites, and expanded

enrollment pools.

Acted as primary liaison between sites, sponsors, and IRBs.

Reviewed study protocols and analysis plans and created case report forms ensuring all needed data was collected appropriately

following Good Clinical Practice and respecting Health Insurance Portability and Accountability Act.

Clinical Research Coordinator University of Minnesota December 2011-April 2012

Completed Case Report Forms for National Institute of Health funded kidney transplant genomics study to meet data lock

deadline.

Reviewed electronic medical records (EPIC, Allscripts, OTTR) to extract study data.

Ensure accuracy of departmental databases. Address found discrepancies.

Informed Consent Specialist Medtronic Via Medfocus July 2011-November 2011

Wrote study specific Informed Consent Forms (ICFs) templates containing all required elements of consent. Reviewed and

approved site specific ICFs following Standard Operating Procedures and obtaining all necessary legal review.

Prepared Master Clinical Trial Agreement resource to aid in contract negotiations.

Community Program Specialist UniverSity of Minnesota May 2005-July 2009

Acted as lead coordinator for CARDIA Fitness Year 20 exam. Full time staff research assistant for ACCORD Study.

Obtained informed consent form over 1000 participants in multiple studies ensuring proper documentation.

Organized and maintained more than 10,000 patient years of study data including Case Report Forms.

Peer reviewed and internally monitored other interviewer’s surveys and CRFs for accuracy and completion.

Trained and certified peer coordinators to maintain study required certifications.

Developed screening tools to assess patient eligibility.

Met study enrollment goals.

Recorded adverse events, collected all required documentation for event adjudication.

Coordinated communication with participants’ primary care physicians and study physicians.

Designed forms for receiving, processing, and transmitting accelerometer data.

Schedule staff, participants, and rooms for study exams.

Page 2

Page 3

Contact this candidate