Margaret M. Leutwyler has over 20 years of experience in clinical research and human resources. She has worked in roles such as a Temperature Management Coordinator ensuring compliance with clinical trial protocols, a Project Manager obtaining supplies for clinical trials, and a Clinical Research Associate monitoring trials and ensuring compliance with regulations. She has strong communication, organizational, and problem-solving skills. Her resume details employment history and education including a BA in Psychology from the University of North Carolina.

1. Margaret M. Leutwyler
107 Cherry Lane
Dublin, PA 18917
267-945-3532
margaretleutwyler@yahoo.com
Strengths: Excellent written and oral communication skills, reliable and team oriented,
highly organized and efficient, learn new skills quickly, welcome new challenges, well-
versed in pharmaceutical record keeping systems (eTMF, CTMS)
Employment History:
September 2015 – Present
Telerx
Horsham, PA
Human Resources Account Representative
Responsible for handling internal human resources inquiries for Merck & Co.
October 2013 – January 2015
Janssen Pharmaceutical
Horsham, PA
Temperature Management Coordinator
Responsible for management of all temperature excursions associated to clinical
supplies during the trial execution ensuring prompt resolution and compliance with all
SOP, GMP, Quality, and Regulatory guidelines. Managed sites’ with temperature
excursions and assisted all sites with regular monitoring of clinical IP temperature
ranges.
July 2013 – October 2013
Ancillare
Horsham, PA
Project Manager
Worked closely with sponsor companies and clinical sites to provide
ancillary study supplies. Worked with outside vendors to obtain the supplies
needed for each study and ensure that the sponsor receives quality and
cost-effective items. Assisted sites with budgets and prepared invoices for the CRO
and/or the sites.
April 2007 – April 2013
PRA International
Horsham, PA
In-House Clinical Research Associate III (Senior In-House CRA)/ Clinical Research
Associate I(Oncology, Pain Management, Alzheimer’s Disease, Anxiety, Pediatric
Gastroenterology, Gastroenterology)/ Project Assistant I

2. Worked closely with the Clinical Team Managers and Clinical Research
Associates to provide support, assisting with the preparation and
organization of investigator and study site materials both at a local and
international level (assisted with CRF creation and editing and preparing budgets for
studies). Monitored the progress of clinical studies at investigative sites or remotely and
ensured the clinical trials were conducted, recorded and reported in
accordance with the protocol, standard operating procedures and ICH-GCP.
March 2006 – March 2007
Krempa Associates, Inc.
Fountainville, PA
Office Manager
Supported the President, Vice-President and Branch Manager and managed small
office of eight employees.
August 2005 – March 2006
First Managed Care Option
Fort Washington, PA
Administrative Assistant
Supported the Vice-President/General Manager and two Case
Management Nurses.
February 1999 – June 2005
Doylestown Hospital
Doylestown, PA
Senior Administrative Assistant - Medical Staff Services/Institutional Review Board
Coordinator - Clinical Research Department/Senior Administrative Assistant – Patient
Education
Supported Diabetes Education Coordinator, supported Nutrition Education Coordinator.
Supported the Vice-President/Chief of the Medical Staff and the Director of
Clinical Research Department.
.
Education:
1993 – 1995 University of North Carolina
Chapel Hill, NC
BA Psychology
1991 – 1993 Bucks County Community College
Newtown, PA
AA Psychology
Dean’s List, President’s List, Phi Theta Kappa
1981 – 1985 Archbishop Ryan High School
Philadelphia, PA